Access to Life-Saving Medicine Act

Mr. President, I rise in support of S. 1082, the Food and Drug Administration Revitalization Act.

This legislation addresses many critical issues, including the need for provide proper incentives and support for the development and review of pharmaceuticals and medical devices, including products for children, and the need for heightened efforts to assure the safety of medications.

As we debate this legislation, let us remember we all have the same goals in mind.

We want Americans to benefit from life-saving, life-enhancing drug and device products.

We want Americans to have access to drugs that are safe and effective.

We want Americans to have all the relevant safety information available on their drugs.

And, indeed, we want Americans to know that the Food and Drug Administration, the agency responsible for ensuring drug and device safety, has the resources to do its job.

That is what this bill is all about protecting Americans and giving the FDA the tools to do its job.

The legislation before us reauthorizes both the Prescription Drug User Fee Act, better known as PDUFA, and the Medical Device User Modernization Fee Act, better known as MDUFMA.

It is of critical importance that both programs be authorized by the end of the fiscal year. This legislation embodies the agreements reached by both industries and the FDA, along with refinements added by the Congress.

Let me make clear that I am supportive of these reauthorizations. It is fair to say that I had reservations about PDUFA when it was enacted in 1992, questioning the wisdom of whether an industry should be required to support a governmental function. To a certain extent, I still have those reservations. That being said, it has become abundantly clear that there are not the resources in the Agriculture Appropriations bill to support these review functions absent a user fee, and thus I recognize their necessity.

With regard to MDUFMA, I have been particularly concerned about the impact that user fees could have on small medical device manufacturers, many of which are located in Utah. Indeed, I am proud that there are over 100 medical device companies in Utah, companies that represent the best in American innovation. They are true world leaders in their industry.

The changes made in the last reauthorization at my request, along with the new structure of the user fee in FDARA and the improved trigger provision satisfy me that the manufacturers are being fairly treated by the user fee program in this bill. And, indeed, this is a serious concern.

In February of 2006, the Lewin Group prepared a report for the FDA entitled ``Medical Device Industry Perspectives on MDUFMA. That report revealed that senior industry experts felt FDA is generally doing an excellent job in premarket regulation of medical devices and that the industry was generally supportive of the purpose and goals of MDUFMA. However, key among the findings was the fact that the industry perceived little or no evidence of attaining the main intent of the program or in realizing a favorable return on investment from user fees. In fact, whenever I return to Utah to meet with medical device executives, I hear the same concern. And it is a concern I share.

Indicative of that concern is the astounding fact that 70 percent of responding device manufacturers perceived that MDUFMA goals have not resulted in meaningful improvements in either the predictability or timeliness of reviews. In fact, when I reviewed the device approval times, I understood those concerns. For some classes of devices, FDA had made great progress. For others not. This was disturbing to me, since we would all hope that progress would have been made across the board.

It is my hope with the new fee structure embodied in S. 1082, we will make better progress in achieving the approval time goals. I am pleased that Chairman Kennedy and Senator Enzi included provisions at my request which make certain the fees for smaller companies are affordable.

Let me turn to the issue of direct-to-consumer advertising, or DTC. This is an issue on which our colleague, the senior Senator from Kansas, Mr. Pat Roberts, has shown great leadership, both in the HELP Committee, and here in the Senate Chamber. Senator Roberts has led the charge to eliminate the 2-year moratorium on prescription advertising for newly approved drugs. He has expressed constitutional concerns about such a moratorium. I share those concerns. He is right to bring this up.

In general, I believe we should be guided by a very simple rule. Advertising about products the FDA regulates should be truthful and not misleading.

I do understand the arguments that some in this body make with respect to pharmaceutical advertising. Some nights, when I watch television, those ads do become tiresome. But I could say that about a lot of ads.

Some have argued we need to be particularly careful about what pharmaceutical advertising is allowed, because we have limited knowledge about drugs, especially when they come on the market.

Those who make such arguments fail to recognize that FDARA will guarantee that consumers have access to greater clinical and safety information about medications because it gives the FDA more authority to review and react to drug safety data. User fees created by S. 1082 will bolster the FDA office responsible for reviewing drug advertisements.

The FDA has told my office and others that drug manufacturers cooperate fully with the FDA when a concern is raised about an advertisement. That would be my preference for how these ads should be handled.

I am hopeful we will be able to address this issue and I am encouraged by recent discussions involving the Senator from Kansas and others members of the Senate HELP Committee.

The bill's drug safety provisions are probably its most important component. Indeed, shortly after the Institute of Medicine issued its report on this issue, we all began to see a floor of letters in support of efforts to improve the drug safety program.

Members of the HELP Committee undertook serious discussions on how to address the problems that have been identified, and the result is this legislation developed by Senator Enzi and Chairman Kennedy. The Enzi- Kennedy bill has benefited from the guidance of our colleagues, former Chairman Gregg and Senator Burr, who have pointed out the necessity for more flexibility in determining when a risk evaluation mitigation plan--or REMS--is needed. Senator Coburn added greatly to the discussion by raising issues relating to the access of our constituents in rural areas to needed pharmaceuticals.

I believe the product of these discussions strikes the appropriate balance. It requires, for example, that determining whether the FDA should further assess the safety of a drug should be based on scientific evidence. To me, that is probably the most integral part of this bill--when concerns are raised about drugs, these concerns must be based on scientific evidence and not on innuendos or hearsay. This approach allows proper evaluation of relevant information and gives the FDA greater authority to warn consumers when there are problems.

In addition, the drug safety title strengthens the FDA's existing authority to monitor drugs once they have been approved by making it clear that evaluation must occur before and after approval. One of the most important components of this legislation is that more drug safety information will be made more available to the public. I believe that is an important victory for the American consumer.

I also want to take a few minutes to talk about the pediatric testing and research provisions included in this bill.

I have supported both the Best Pharmaceuticals for Children Act and the Pediatric Research Improvement Act. In fact, I have supported these efforts since our former colleague from Ohio, Senator Mike DeWine, brought the need for additional pediatric testing of prescription drugs to our attention during consideration of the FDA Modernization Act of 1997. He fought long and hard to encourage drug companies to conduct clinical trials on pediatric uses of their drugs. His efforts paid off and this program has been extremely successful.

My good friend and colleague from Connecticut, subcommittee Chairman Chris Dodd, has also shown great leadership on this issue when FDAMA was being considered in 1997. He held a hearing on this issue earlier this year with his ranking Republican member, Senator Lamar Alexander. That hearing was very insightful and I believe that many of us are trying to do the right thing as we reauthorize both programs.

I urge my colleagues not to lose sight of the purpose of these two programs as we make decisions on this part of the bill. We want good, solid information about the safest way to prescribe drugs for children. And by giving companies market exclusivity to conduct clinical trials, we will know the safest dosage levels for children. So let us not lose sight of the original propose of these programs--to help children have the safest dosages for prescriptions. I am hopeful that we will be able to work out our differences on these provisions on these very important issues.

Food safety is another issue that is on nearly everyone's mind these days. When I was a kid, we were always told to eat our spinach so we could grow muscles like Popeye. Peanut butter is almost a staple for most Americans. And yet these ordinary, common foods have harmed rather than helped. Pets are getting sick and we have discovered that their food has been contaminated. Something needs to be done.

I have worked with Senators Kennedy, Enzi, Durbin and Allard to figure out a constructive approach to these important issues. I think that we have made a lot of progress and I look forward continuing those discussions as the bill progresses toward enactment.

One factor that is not discussed enough is the need to appropriate more funding for inspectors and inspector training, especially abroad. I can recall over a decade though when Jim Phillips, a former investigator for the FDA, brought to our attention the woefully lacking FDA resources for foreign inspections. We were shocked then, and unfortunately, we are shocked now.

Today, only one percent of imported food is inspected. I believe this issue needs to be carefully reviewed by Congress so people no longer have to worry about whether food for them or their pets is safe.

I offered and withdrew an amendment during the HELP Committee consideration of this bill that would address another important issue. My amendment had several provisions which encouraged innovation and development of safe antibiotics, required the FDA to convene a meeting to determine how the Orphan Drug Act should be applied to antibiotics, and reauthorized the grant programs for the Orphan Drug Act. Finally, my amendment provided for a 5-year exclusivity for enantiomers of previously approved racemic drugs if and only if, one, they are approved for new therapeutic uses and, two, a completely new data set has been created for approval of this enantiomer. It is my expectation that our current discussions on these provisions will lead toward their adoption later in the week.

I also want to point out that there have been many discussions on ways to ensure that citizens' petitions do not unfairly delay generic drug approvals. I believe this is a problem, although I do not believe it is of a magnitude as some would suggest. I do not oppose making changes to ensure that any abuses in this area are stopped, as long as FDA still has the ability to do the appropriate scientific and legal review of abbreviated new drug approval applications in the timeframe it desires.

Let me turn now to one provision which is not in the bill: language authorizing a pathway for the Food and Drug Administration to approve copies of biologics. This is commonly referred to as the ``biosimilars,'' ``biogenerics,'' or ``follow-on biologics'' legislation. Senator Gregg spoke so well about this subject just a few minutes ago.

While language on this issue is not included in the bill we consider today, I want to make perfectly clear that it is my intention to work toward development of an acceptable compromise that can be included in the final version of FDARA and signed into law. It is my hope Senators will refrain from offering any amendments on this issue until we have time to develop consensus. And I do believe consensus can be developed without delay. It is my intention to do so.

As my colleagues are aware, I am the Hatch of Hatch-Waxman. I have a serious interest in making certain the law Chairman Waxman and I developed in 1984, the Drug Price Competition and Patent Term Restoration Act, is used as the basis for development of legislation to provide an abbreviated pathway for approval of follow-on biological products. In so doing, we must make certain we include the appropriate incentives for development of those products. Indeed, that is my high priority.

By any estimate, the Hatch-Waxman law has done consumers tremendous good by fostering today's modern generic drug industry. It has saved patients literally billions of dollars. Similarly, using it as a basis for development of a pathway for follow-on biologics will help consumers with access to the innovative, life-affirming biologic products. But in so doing, we must be mindful of the fact that we need to encourage and nurture the innovation that provides the biologics that the generic companies seek to copy. This is a tremendously complicated task, but it is one worth doing.

In 1984, when Chairman Waxman and I undertook a series of negotiations that led to approval of the Drug Price Competition and Patent Term Restoration Act, it was a very different time.

There were no cell phones, no DVDs, almost no one had a personal computer, and a stamp cost 20 cents

It was a much less complicated time. Generic drugs were a small, struggling industry, with no discernible footprint in the pharmaceutical world. The innovators had yet to respond to their first paragraph IV certification. In 1984, brands versus generics largely an American endeavor. Today, the pharmaceutical market--both innovator and generic--is an international marker--for research, development and marketing.

Biological products were not an issue in 1984. Today, they are becoming an increasingly larger part of pharmaceutical spending.

It is my strong belief that we can learn from this experience and build another solid law that will help consumers--both by supporting the incentive to discover and develop new biologics, and by fostering a climate that will lead to lower prices. This is a classic win-win situation.

And why is that so important?

A February report by the Center for Medicare and Medicaid Services paints the picture very well: America's health care spending in the next 10 years will double to $4.1 trillion. Or, to look at it another way, that is 20 cents out of every dollar spent. We spend about $7,500 per capita on health care in the U.S. Yet in 2016, that will rise to an astounding $12,800 per person. Greater spending for pharmaceuticals is expected to fuel much of the increase, the report's authors concluded.

And there it is in a nutshell. The good news and the bad news.

Not much worries Congress more than the costs of medical care--both from the perspective of a balanced budget, and from the view of our constituents' pocketbooks.

In many ways, it is an embarrassment of riches.

We have exciting new therapies to treat our medical ills--new drugs, new devices, stem cell treatments. Their potential to improve human health and well-being is almost limitless.

And yet the cost of those treatments, the impact they have on the budget, at times seems equally limitless. In fact, in 2005, prescription drug spending was estimated at $214 billion, a healthy amount by anyone's measure. That same year, spending on biologics was estimated at $32 billion.

Since biologicals are generally more expensive products, ways to reduce their costs interest policymakers and

other stakeholders in expenditure of the health care dollar, foremost among them employers, insurers, pharmacy benefits managers, and of course, the government.

Comes now the generic drug industry, which has been proven to provide alternative, safe and effective therapies in a much more cost beneficial manner. We look to them to be part of the solution to this problem. And they, in turn, look to us to help them be part of that solution.

It is no secret that several senators have been meeting to develop a bill that would establish a pathway for biosimilar products to be approved by the Food and Drug Administration. We had hoped to have it ready for inclusion in FDARA, but it was not, despite the talks of the four Senators. I am referring to Health, Education, Labor, and Pensions Committee Chairman Ted Kennedy, the committee's ranking Republican, Mike Enzi, Senator Hillary Clinton, and me. All members of the HELP Committee, we have worked to develop consensus on what legislation would include.

Senator Kennedy and I began these talks several months ago. He is committed to developing a bill on a priority basis. Our staffs literally have been working night and day.

Our work has been aided immeasurably by the leadership of Chairman Waxman, and in the Senate, Senator Chuck Schumer and Senator Clinton, who have introduced the companion to the Waxman bill. Their legislation, the Access to Life-Saving Medicine Act, H.R. 1038/S. 623, provides a solid starting point for discussions. It is an important work that has added immeasurably to the congressional dialogue.

It is my hope that our discussions will also be informed by the work of Representatives Jay Inslee, Gene Green and Tammy Baldwin, who recently introduced the Patient Protection and Innovative Biologic Medicines Act of 2007, H.R. 1956, and by the views of the many, many stakeholders in this legislative effort.

The time to develop a pathway for approval of biosimilar products is long past overdue. It should be our priority, and it should be our high priority, to get it done this year. But, we should get it done right. Our deliberations must be based on science. The original balance of the law must be maintained, but we must also recognize the emerging realities of this new world.

And what are those realities? First, biotechnology products are not drugs; they are very complicated molecules that are not easily reproduced. An inadvertent change in the structure of that molecule can lead to very devastating consequences.

Second, today, it is unlikely that any follow-on company will be able to produce an exact copy of a biotech molecule, a generic biologic if you will, at least at first.

Third, because science advances, and because American researchers are very good at advancing science--stem cell research is one example that comes readily to mind--we must hold open the possibility that one day there will be true biogenerics.

And we must also develop a pathway so that biosimilar products can be approved without a full biologics license application, a time-consuming and expensive process.

But whatever policy we develop, it must be based on soundness of science, rather than the practicalities of politics.

Fourth, we must take into account the unique nature of today's industry. This is so much more than an exercise between big Pharma and the generics, or even between big bio and the generics.

Indeed, there are about 1,400 biotech companies in the United States. How many of them are profitable? Astoundingly, only 20.

Many of these companies are small, with revenues of under a million dollars per year. Many do not even have a product on the market.

We must examine closely the issue of who will be making biosimilars? Will it be the Barr Labs and Tevas of the world? Undoubtedly.

But it may also be generic subsidiaries of innovator companies.

It is also very likely to be companies in India and China. As we have seen with the recent concerns over pet food, inspecting foreign manufacturing plants has historically been a problem for the resource- constrained Food and Drug Administration.

Fifth, we must use the framework of Hatch-Waxman where we can, but we must recognize there may be ways to improve it.

There are obvious differences between regulating a pathway for biosimilars and for copies of chemical drugs. For example, as I mentioned, today's science will probably not allow identical copies of today's biologics. So, the concept of bioequivalence cannot be imported into this debate. Instead, we must work carefully to define biosimilarity.

Another difference today is the fact that process patents are much more integrally tied to the manufacture of biologics. Current law does not require listing of process patents in the orange book.

Waxman-Hatch is inherently a litigious process. But its framework-- the patent holder or drug manufacturer--v. the generic--does not easily translate to a system in which multiple patent holders may exist, including, for example, major universities and research centers.

Sixth, the incentives for development of biotech products must be maintained, enhanced where it advances public policy. But at the same time, we cannot seed a new generation of roadblocks that preclude biosimilar entry. This is the nub of the key, crucial balance.

Seventh, the role of the FDA must be carefully evaluated. We must empower the agency to evaluate pure, safe and potent copies of biotech products, but we must all recognize that there must be a bright line that separates a safe copy from a new product which should be subject to a full biologic license application.

We need to free the agency and provide it with the flexibility to evaluate the adequacy of a biosimilar submission based on good science, but we must also recognize that, as Commissioner von Eschenbach has said, there may be some products which cannot be copied safely with today's science.

Eighth, we must make certain the resources are there for the FDA to do the job right. I must note that negotiations between the agency and the pharmaceutical industry on the Prescription Drug User Fee Act reauthorization, or PDUFA, took over one year. Every indication I have is that review of a biosimilar application is very likely to be more complex and time consuming than that for a new biologics license application.

There must be authority for a fee to be collected that reflects this complex workload. If we do not provide adequate resources to the FDA, then review of new products could suffer at the expense of cheaper copies as reviewers become siphoned off from new products to the biosimilars. We should not design a system in which this occurs.

And I must digress at this point to underscore that the FDA is already cash-strapped and that situation simply must be corrected. The dire FDA resources issue appears to have manifested iself in such recent revelations as to the inadequacy of food inspections for some of the most ubiquitous products in American life, including pet food and peanut butter.

Federal policymakers must take this into account when legislating, and the Food and Drug Administration Revitalization Act is a good place to start.

Enacting follow-on biologics legislation is a top priority for me. I want us to finalize a bill on a priority basis, and it is my hope it can be included in the final version of FDARA that emerges from the conference committee.

Before I close, I want to talk about one other issue that is often debated when FDA-related legislation is considered on the floor: importation of prescription drugs. This morning, I listened to our colleague, the Senator from North Dakota, Mr. Dorgan, talk about his legislation which allows prescription drugs from other countries to be imported into the United States from other countries. My colleague refers to this as drug reimportation which I believe gives people the false impression that these drugs are originally manufactured in the United States, exported to another country and then imported back to the United States. I just want to clarify that is not typically the case.

In addition, I saw the Senator from North Dakota hold up two bottles of

Lipitor and say that there is no difference between a drug manufactured in Ireland and a drug manufactured in the United States. He suggested that the pills may be different colors but the bottles are the same and the medicine in the bottle is the same.

That may be true for the two bottles of drugs that he had on the Senate floor. But how could we be assured that is always the case? Can we always guarantee that pills in a bottle labeled from Ireland are actually manufactured in Ireland? I don't think so.

This issue is the crux of the problem--unless the FDA has approved these medications, we have no way of knowing what is actually in the bottle. In fact, when I served as chairman of the Senate Judiciary Committee, I held a hearing on drug importation and this issue was raised by one of the members of the committee. At that July 14, 2004, hearing, one Senator specifically asked about a prescription drug bottle labeled as being from Canada. William Hubbard, the Associate Commissioner for Policy and Planning for the FDA, told her that even though the label said the bottle was from Canada, the FDA had no idea where that bottle had originated.

In fact, at that hearing, Mr. Hubbard said:

Although some purchasers of drugs from foreign sources may

receive genuine product, others may unknowingly buy

counterfeit copies that contain only inert ingredients,

legitimate drugs that are outdated and have been diverted to

unscrupulous resellers, or dangerous sub-potent or super-

potent products that were improperly manufactured.

Furthermore, in the case of foreign-based sources, if a

consumer has an adverse drug reaction or any other problem,

the consumer may have little or no recourse either because

the operator of the pharmacy often is not known, or the

physical location of the seller is unknown or beyond the

consumer's reach. FDA has only limited ability to take action

against these foreign operators.

On a related issue, I would like to share Mr. Hubbard's insights on the safety of drugs that have been imported from other countries.

FDA remains concerned about the public health implications

of unapproved prescription drugs from entities seeking to

profit by getting around U.S. legal standards for drug safety

and effectiveness. Many drugs obtained from foreign sources

that either purport to be or appear to be the same as U.S.-

approved prescription drugs are, in fact, of unknown quality.

Consumers are exposed to a number of potential risks when

they purchase drugs from foreign sources or from sources that

are not operated by pharmacies properly licensed under state

pharmacy laws. These outlets may dispense expired, subpotent,

contaminated or counterfeit product, the wrong or a

contraindicated product, an incorrect dose, or medication

unaccompanied by adequate directions for use. The labeling of

the drug may not be in English and therefore important

information regarding dosage, warnings and side effects may

not be available to the consumer. The drugs may not have been

packaged and stored under appropriate conditions to prevent

degradation, and there is no assurance that these products

were manufactured under current good manufacturing practice

(cGMP) standards. When consumers take such medications, they

face risks of dangerous drug interactions and/or of suffering

adverse events, some of which can be life-threatening. More

commonly, if the drugs are subpotent or ineffective, they may

suffer complications from the illnesses that their

prescriptions were intended to treat, without ever knowing

the true cause.

Mr. President, this was a sobering hearing and I urge my colleagues, especially those who support the importation of prescription drugs into this country, to take the time to review the testimony from the July 14, 2004, hearing. We had many witnesses who provided valuable insights on this issue.

To address Senator Dorgan's other point regarding the cost of prescription drugs, I want to make one thing perfectly clear--I want Americans to have access to affordable drugs, but I also want these drugs to be safe and effective. As one of the authors of Hatch-Waxman, I understand the problem of pharmaceutical costs, and I have a record of working to find solutions. But bringing potentially unsafe medicines, medicines uncertified by the FDA, into the United States is not a solution.

In conclusion, I ask my colleagues who are skeptical about this bill to reserve judgment and listen carefully to the debate. While I supported this bill when it was considered by the Senate HELP Committee 2 weeks ago, I honestly believe that members of the HELP Committee have worked hard together to make the reported bill even better. So I urge my colleagues to take the time to review the bill because there are a lot of good provisions in it.

I would like to take this opportunity to recognize the hard work of the staffs of both our committee chairman, Senator Kennedy, and our ranking minority member, Senator Enzi. I would specifically like to thank Amy Muhlberg and David Dorsey for their dedication and hard work on this issue--they have been working on drug safety legislation for over 2 years and I want both of them to know how much all of us appreciate their efforts. I also want to recognize Shana Christrup and David Bowen for their leadership in helping their bosses get this bill to the floor under very difficult time constraints. All of the HELP Committee members' staff have worked long hours and many weekend hours and I just want you to know how much I appreciate all of you.

Mr. President, I yield the floor.

As usual, my dear friend from North Dakota is articulate, and he deserves to be listened to, but I disagree with him.

The Dorgan amendment allows individuals to import a qualifying drug, and this will pose an overwhelming set of resource burdens for the FDA, Customs, and other agencies, especially

the FDA. It would, as I have mentioned before, create very significant safety concerns.

This amendment establishes a complicated system for the regulation of imported drugs. Now this system that he suggests is so vast, it would take and require a lot of money, more than all of the proposed fees could support.

Where would an already strapped Federal agency such as FDA get these additional dollars? So far we have not given it to them. There have been estimates that these dollars would amount to so much that there is no way that we could give them enough money.

This amendment allows foreign-imported products to be approved for distribution in the United States even when they may not be bioequivalent to the FDA-approved products. Now the reason I cite that is because the letter from the FDA, this letter was sent to the Honorable Byron L. Dorgan, Senator Dorgan. This letter was sent April 10, 2007.

I ask unanimous consent that this letter be printed at the conclusion of my remarks.

In that letter, just to mention a couple of things, the Acting Deputy Commissioner for Policy, Randall W. Lutter, Ph.D.--let me just mention a couple of sentences.

He said:

Nevertheless, the Agency continues to have concerns with

enacting such a sweeping importation program and fears that

intermediaries would likely swallow the bulk of cost-savings,

preventing the American consumers from enjoying much, if any,

practical benefit from such a program.

On safety concerns, he said:

We have safety concerns related to both the identification

of unsafe or non-complaint drug products and about the

substitutability for domestic products.

On identifying unsafe/noncompliant drug products, he said:

The section of the bill that would allow individuals to

import a qualifying drug from a registered exporter would

likely pose an overwhelming resource burden for the Agency

and create significant safety concerns.

Just reading at random:

S.242 would establish a complicated system for the

regulation of imported drugs. This complex system is so vast

that it would be enormously resource-intensive, likely much

greater than the proposed registration fees and inspection

fees could support.

On a lack of substitutability, he said:

The proposed bill provides a mechanism for foreign imported

products to be approved for distribution in the U.S. even

though these products may not be bioequivalent to the FDA-

approved product.

This letter is a serious letter. I don't think we should ignore letters such as these in our zeal to resolve problems. I believe the distinguished Senator from North Dakota is very well intentioned. I have a tremendous regard for him and for his ability to explain things on the floor of the Senate.

I also ask unanimous consent to have printed in the Record excerpts of the testimony before the Senate Judiciary Committee on July 14, 2004, entitled ``Examining the Implications of Drug Importation,'' of Mr. William Hubbard, Associate Commissioner for Policy and Planning of the U.S. FDA.

These are serious statements by serious people. I don't think we should ignore them. It is one thing to argue that you don't like the pharmaceutical companies, and many don't. It is another thing to argue that these drugs that are going to be imported or reimported are absolute identical copies of what they represent. I would pay attention to what these people are saying.

I also ask unanimous consent to print in the Record the statement of a Customs officer who came and testified on the 14th.

It was a startling statement. I know at least one Democratic Senator, who takes matters very seriously and who was for importation or reimportation of drugs, was shocked at some of the testimony because she did not believe things could be as bad as they represented and was kind of shocked that they made a pretty darn good case that these matters are much more serious than some are taking them.

I don't have anything more to say at this time, but I hope we will think this through before we saddle the American people with something that can be disastrous in their lives. I am familiar with how some of these drugs that people think are good drugs that come into this country are adulterated. Some are made with contaminated water, do not have any efficacy in them at all. Yet they look identical to what our U.S. manufacturers are making or what other qualified manufacturers are doing. We can't ignore these things. I think even if we could give FDA all the money--and it would amount to trillions of dollars, certainly hundreds of billions of dollars but I think trillions of dollars--to handle this, there is still no way FDA can take care of all the problems that would come up.

We have a pretty good system here. I have to admit, I wish we could get drug prices down. As the author of the Hatch-Waxman Act, we worked hard to get the generic business into action. At the time we did Hatch- Waxman, generics were no more than 17 or 18

percent of the total marketplace. Today they are over 50 percent. Hatch-Waxman is the reason they are there. In every case, every year we have saved at least $10 billion for the consumers. What many in this body seem to ignore is that it costs these innovator companies upwards of $1 billion to create one of these drugs. Most of them go through at least 6,000 failed experiments before they arrive at one of these drugs. We can't ignore that fact. The only way they can recoup that money is within the few years that are left of their patent life.

This is the only industry I know of--there may be others, but I can't think of any--where if you create a widget, you have 20 years of patent life, market exclusivity. In this industry, a lot of that is eaten up by the FDA process. It means that the innovator companies have very few years in which to recoup that billion dollars, upwards of a billion dollars. A few years ago, it was $800 million, which was astounding to me. Now it is approaching a billion; in some cases, maybe even more.

It is one thing to throttle the pharmaceutical companies in the interest of politics. It is another thing to ignore reality and ignore what happens here.

One reason for Hatch-Waxman was because one side wanted all drug price competition. They wanted 100 percent generics if they could get them. The problem is, there would not be any generics if you don't have the innovator companies doing the innovative drugs.

Sure.

I have heard some who I believe are using it politically in the Congress. But I would never ascribe that type of attitude to the distinguished Senator from North Dakota. I believe he is very sincere. I believe he is truly trying to represent the consumers in the best possible way. I just believe he is ignoring some of these comments and statements made under oath before committees of the Senate that fly in the face of what is being said here. I would like to see drug prices reduced. There is no question about it. I worked hard to get them reduced. That is what Hatch-Waxman is all about. But there are two sides to that. One was drug price competition, to make sure we could get drugs in generic form immediately, once they come off patent, which we did. The other, of course, is the patent term restoration so that we could give innovator companies some restoration of patent life or market exclusivity so they could recoup the moneys, the extraordinary costs that are involved.

When I say I have heard some in the Congress who I think have exploited this for political purposes, I would never say that about my friend from North Dakota. I don't particularly want to disparage anybody else, but I can say this: There have been some who have used this issue politically, and there is no doubt about it. I believe the Senator from North Dakota is articulate and means what he says and is doing so for the right reasons. Having said that, I don't think we should ignore the testimony of these top people in the administration who say this could be a disaster for the American consuming public. I don't think you can ignore those comments. I am suggesting that I hope people will read these comments, and I will put more into the record before we are through with this debate. We are all interested in getting drug prices down. There is no question about it. I don't think there is anybody in this Congress who has done more to bring drug prices down than I have, through Hatch-Waxman and my friend Henry Waxman over in the House and others who supported that bill. There is no question about it. I am as interested as anybody in making sure the consumer public is not ripped off.

On the other hand, these innovative drugs cost a lot of money to develop. When we get into follow-on biologics, it apparently costs even more for these large-molecule drugs that may not be readily duplicated. In fact, under current science, they are not readily duplicated. I am very concerned about this whole issue. I am very concerned about making sure that the record shows that we have brought out how serious this issue is and how serious the consequences are if people are wrong, if they happen to get this type of legislation through.

Let me add one other thing. I would suggest to my friend from North Dakota that the President has already said that if this language is in this bill, he is going to veto it. I believe that veto would be sustained. I think it should be sustained. It is one thing to come out and argue for something such as this, but I would hope that he will withdraw his amendment because I would hate to see a bill as important to our country as this drug safety bill, a bill that has brought together Democrats and Republicans from the left to the right, a bill that would help to save as many lives as this bill will do, a bill that will help bring to the forefront the FDA in a way that it should be brought, a bill that has the MDUFA and PDUFA moneys in, a bill that has children's programs in, I would hate to see this bill vetoed, but I would not blame the President one bit if he vetoes it based upon the testimony of scientists who have testified before our committees.

Frankly, I would think he would be right if he vetoed it. But be that as it may, I am only one Senator, and I think most people know I am very sincere in this area. I work very hard in these areas. I have a record of accomplishment in these areas. I just want to make sure that our consuming public has every protection they possibly can. Unfortunately, it costs a lot of money to give them that protection. I wish there was some way we could bring those prices down.

Having said that, back in the early 1990s, I helped put through this body the FDA Revitalization Act. Among the purposes of that act was to create a unitary campus for FDA rather than have over 30 different locations in the greater metropolitan area around the District of Columbia, to have a central campus, state-of-the-art equipment, the highest technology we can, with an incentive to bring the very best scientific minds we can into FDA. We all know the White Oak complex is being built now. It didn't start until about 5 or 6 years ago. It is going to take another 10 years and probably cost a lot more than it would have had we done what that bill said we could do immediately. It was only an authorizing bill. The appropriators did not appropriate the funds to develop that campus. But we have to find a way of helping FDA. The sooner we get that campus and they have all of the integral online services and equipment and top-of-the-line approaches that they can bring to bear, we should be able to bring drug prices down through that. But we are a long way from the completion of White Oak, as we stand here today.

Frankly, at least we are doing it. At least we are going somewhere. I wish to attribute some of that to the distinguished Senator from Maryland, Barbara Mikulski, and others in the House who have worked very hard to make sure that the FDA revitalization approach finally comes to fruition.

One of the biggest problems we have in Government today is to get top scientists at FDA. We can't pay them commensurate with scientists at the major pharmaceuticals or even the major generic companies. In fact, they can start at three times or more what we pay at FDA. So we have a very difficult time continuously getting top scientists to come and work at FDA. That is a big problem. It is a blessing that we do have some of the best scientists in the world working there who are willing to sacrifice to do what they consider to be the important work of the Food and Drug Administration. This bill will help the Food and Drug Administration to do a better job, to go forward with more backing from the Congress and, in the end, benefit all of us who benefit so much from the work of the Food and Drug Administration.

I yield the floor.

Exhibit 1

Department of Health and Human Services, Food and Drug

Administration

Rockville, MD, April 10, 2007.

Hon. Byron L. Dorgan,

Chairman, Subcommittee on Interstate Commerce, Trade and

Tourism, Committee on Commerce, Science, and

Transportation, U.S. Senate, Washington, DC.

Dear Senator Dorgan: Thank you for the opportunity to

testify at the March 7, 2007, hearing entitled, ``Policy

Implications of Pharmaceutical Importation for U.S.

Consumers,'' before the Senate Subcommittee on Interstate

Commerce, Trade, and Tourism. The Food and Drug

Administration (FDA or the Agency) is responding to address

the March 9, 2007, correspondence you sent in follow-up to

that hearing.

Your correspondence included statements made by former FDA

Commissioner, David Kessler, at an April 19, 2005, hearing

entitled, ``Examining S. 334, to amend the Federal Food,

Drug, and Cosmetic Act with respect to the importation of

prescription drugs,'' held by the Senate Committee on Health,

Education, Labor, and Pensions. Dr. Kessler's statements

focused on the issues of safety, resources, supply chain

security, and standards for approval of foreign versions of

FDA-approved drugs. You asked that I explain my views on the

``Pharmaceutical Market Access and Drug Safety Act'' in the

context of these issues. The bulk of this response details

our views about these issues.

I would like to start, however, by commending you for your

efforts to address American consumers' concerns regarding

access to affordable prescription medications. Nevertheless,

the Agency continues to have concerns with enacting such a

sweeping importation program and fears that intermediaries

would likely swallow the bulk of cost-savings, preventing

American consumers from enjoying much, if any, practical

benefit from such a program. We expect such a result might

lead consumers to continue to look for substantial savings on

their prescription medications by seeking products outside

the legalized importation system, just as some do now. We

continue to observe that many consumers buy drugs from

foreign Internet sources even though generic versions of

those products are approved by FDA and such products are

generally cheaper in the United States than abroad.

We note that legalizing commercial importation may have

unintended effects on protection of intellectual property and

may reduce incentives for research and development, as noted

in the 2004 report issued by the Health and Human Services'

(HHS) Task Force Report on Drug Importation.

safety concerns

We have safety concerns related to both the identification

of unsafe and or non-compliant drug products and about the

substitutability of foreign products for domestic products.

Identifying unsafe/non-compliant drug products

The section of the bill that would allow individuals to

import a qualifying drug from a registered exporter would

likely pose an overwhelming resource burden for the Agency

and create significant safety concerns. Under such a program,

the anticipated high volume of products would make it

extremely difficult for FDA and U.S. Customs and Border

Protection officials to examine adequately all of the

personally imported drug products to ensure that they comply.

In fact, the HHS Task Force estimated that it would have cost

$3 billion annually to examine and process each of the 10

million packages that entered the U.S. in 2003. Even if a

lower level of examination were considered adequate, the

costs to FDA would still be very high.

Despite its registration and inspection fee provisions, the

bill likely provides inadequate resources to conduct such

examination on a routine basis. Resources are limited to 2.5

percent of the total price of qualifying drugs imported by

registered exporters, an amount likely to be a small fraction

of the cost of inspecting packages at international mail

facilities. This is a particular concern because, once

personal importation is given the appearance of legality,

consumers may be less vigilant in scrutinizing the drug

shipments they receive from abroad.

S. 242 would establish a complicated system for the

regulation of imported drugs. This complex system is so vast

that it would be enormously resource-intensive, likely much

greater than the proposed registration fees and inspection

fees could support. The bill and its associated fees also do

not appear to account for the costs of the increased volume

of packages likely to inundate the U.S., or address the

accompanying and likely substantial enforcement work that

will arise as a result of legalized importation as more

unscrupulous vendors set up shop to circumvent the new U.S.

system.

Lack of substitutability

The proposed bill provides a mechanism for foreign imported

products to be approved for distribution in the U.S. even

though these products may not be bioequivalent to the FDA-

approved product. This mechanism seems to by-pass the

existing drug approval process for drug products that are not

bioequivalent to an FDA-approved product, which is through

the submission of a new drug application (NDA) that is

thoroughly reviewed for safety and efficacy. Ultimately, the

bill appears to establish for imported drugs an alternative

to FDA's existing generic drugs program.

The bill would allow non-bioequivalent products to be sold

in the U.S. as approved ``variations'' of the innovator

product under the existing NDA, which would create confusion

for doctors and pharmacists in prescribing or dispensing,

respectively. Dr. Todd Cecil of the U.S. Pharmacopeia

testified at the April 2005 Senate HELP hearing regarding

pharmaceutical equivalence and bioequivalence and his

concerns with this bill. In addition, doctors cannot

anticipate which version of a drug product their patients

will receive, and pharmacists may not know which version of a

drug the doctor intended to prescribe. The possibility of

confusion is significant and poses a real public health

concern as this increases the chance of error in prescribing

and/or dispensing of medications. In addition, the domestic

and foreign versions of prescription drugs may become

commingled in the drug supply chain. It is unclear whether a

patient will be able to specify if he wants the foreign

version or the original FDA-approved version when he gets his

prescription filled at the pharmacy or receives medication at

a hospital or other medical treatment facility.

Inadequate Resources

It is uncertain whether the anticipated fee revenues will

be realized because the market response to legalization of

importation cannot be accurately predicted. This uncertainty

could pose problems for FDA's program, because large costs of

starting and developing a program to regulate imports will

have to be incurred even if the volume of legalized imports

is initially low. Although the bill does assume certain sales

volumes in the first several years for purposes of collecting

inspection fees, with only a few registered importers and

exporters participating initially, the high pro rata share of

fees may actually discourage participation and make it

difficult for FDA to collect fees at the designated levels.

Even once a program is developed, the bill is not likely to

provide the necessary funds to continue an adequate

regulatory program if inspection fees are low because imports

do not reach the anticipated levels.

Supply Chain Security

We are proud of FDA's efforts with supply chain

stakeholders and states to maintain a safe and secure drug

supply in the U.S. that is premised on a closed, tightly

regulated system. The type of drug importation program in the

bill would increase the number of foreign entities FDA would

have to monitor and regulate. It can be difficult for FDA

enforcement to reach foreign entities violating our laws and

regulations. This bill would open the door to more entities

outside our domestic legal framework. We also have grave

concerns for consumers who may be harmed from products

from these foreign sources. The bill does not take into

account protecting the rights of the consumer if they are

injured after using one of these products.

As we all agree, counterfeit drugs must be kept out of the

U.S. drug supply chain. FDA is currently using its resources

and authorities as efficiently as possible to secure the drug

supply chain and protect American consumers from counterfeit

and diverted drugs. Opening the U.S. drug distribution system

to foreign markets would provide more opportunity for

counterfeit drugs to enter our currently closed system and

would significantly complicate FDA's efforts to investigate

irregularities in the drug supply chain.

Conducting foreign investigations and prosecutions is

inherently costly and difficult and often is complicated by

language barriers and issues of extraterritorial jurisdiction

and extradition. We are concerned that the bill does not

provide sufficient enforcement tools and penalties to deter

foreign entities from introducing counterfeit or otherwise

substandard drugs into the U.S. drug supply chain.

Approval of Foreign Versions

We believe the bill creates complicated application and

inspection requirements for imported ``foreign'' versions of

FDA-approved products. These requirements would be difficult

to implement, as each foreign country has its own regulatory

scheme and requirements for the information necessary to

approve a drug product. FDA would essentially have to review

foreign information in a foreign format, all in less time

than is required for review of traditional NDAs. In addition,

the bill would require imported ``foreign'' versions of a

drug bear the labeling associated with the original FDA-

approved product. This practice would essentially legalize

the misbranding of these products, and raises concerns for

FDA not only in the approval context but also in the

counterfeits context. It is difficult enough for FDA and

other federal enforcement agencies to detect counterfeit drug

products and packaging; creating a mechanism that would allow

persons to label foreign drugs with reproductions of FDA-

approved labeling would make it even harder to distinguish

between ``legal'' foreign products and counterfeits.

U.S. consumers currently have a number of options available

to them when looking for affordable medications within the

closed U.S. drug distribution system. Many essential drugs

have a generic alternative and some even have many generics,

which are generally less expensive than the brand product. We

continue to find that many consumers currently buying foreign

products are actually trying to purchase, or are unknowingly

receiving, a foreign product that

often is more expensive than the U.S. product. In addition,

the consumers are at risk when receiving foreign drug

products, as there are documented cases where the wrong

medication was received (the haloperidol case mentioned in my

testimony). Many pharmaceutical companies and Pharmaceutical

Research and Manufacturers Association of America offer

discounts and sometimes even free medications for consumers

who cannot afford them. Medicare Part D has also helped some

seniors cut their prescription costs. Consumers should not

feel restricted to higher priced innovator (brand) products.

Consumers must also understand that if a medication is

costly, they should discuss other treatment options with

their doctor and pharmacist, as most often there are lower-

cost alternatives available. We will continue to strive to

make more affordable medicines available to consumers, but we

remain concerned about the implications of legalizing drug

importation as one of those options.

In conclusion, I would like to reiterate concerns about the

economic implications of prescription drug importation, as

stated in the 2004 HHS Task Force Report on Drug Importation.

Even if all the safety concerns could be allayed, these

concerns would remain: that savings to U.S. consumers would

be small as a percent of total drug spending; that

implementing such a program would incur significant costs;

and that legalized importation would likely adversely affect

the future development of new drugs for American consumers.

In 2004, the HHS Task Force Report noted that generic drugs

account for most prescription drugs used in the U.S. and that

these are usually less expensive in the U.S. than abroad. We

thus have a well-functioning system of intellectual property

rights that balances the short-term interests of consumers

with the long-term research incentives.

Thank you for the opportunity to address some of our

concerns with S. 242.

Sincerely,

Randall W. Lutter,

Acting Deputy Commissioner for Policy.

Madam President, I ask unanimous consent to speak as in morning business before addressing the pending legislation.

Madam President, there have been comments on the floor about the fact that in just 2 hours the President of the United States will have an opportunity to sign or veto a bill which literally will affect the lives of 150,000 soldiers and their families, if not every American. It is a bill that was passed by the House and Senate, with bipartisan votes in both bodies, and sent to the President. It fully funds the troops in Iraq, giving them all the resources they need, and more, so they can execute this war and their duties in a safe manner.

But it also does something significant; it starts to change the mission in Iraq. We are in the fifth year of this war. We have lost 3,351 American lives. I respect very much the Senator from Wyoming. He tries to make a point that it is not a civil war. My understanding of a civil war is when people of the same nation are at war with one another.

That, sadly, is the reality of what is going on in Iraq today--Iraqis killing one another while Americans stand in the midst of the crossfire. Had the President of the United States come to this Congress in October of 2002 and suggested we send 150,000 soldiers into Iraq for the purpose of refereeing a civil war or a religious war that had its origins in 14 centuries of anger, had he said to us we must stay as long as 5 years and spend $500 billion and risk thousands of American lives, with no end in sight, what were the chances we would have passed that resolution? None. That is not what the President told us.

He told us Iraq was a threat to the United States of America with weapons of mass destruction, and nuclear weapons, that somehow they had been in concert with al-Qaida, that led to 9/11. None of those things turned out to be true--not one of them.

On that basis, we authorized the President to go to war, and he decided to take a preventive course of action--not preemptive but preventive course of action--and invade this country before they threatened the United States. That is what we are in today.

Within 2 hours, the President will pick up a pen and have a chance to start bringing this to an end. If he signs this bill we have sent to him, it will mean that American soldiers can start coming home and that, equally important, the Iraqis understand it is now their country, their war, and their future, that they have to put their lives on the line and not rely on the bravery of our soldiers to keep their country intact.

If the President vetoes this bill, exactly the opposite message goes to the Iraqis. Its message: Continue business as usual. Continue waiting out the political opposition, not resolving your differences, really allowing this religious or civil war to become even worse.

The month of April was the deadliest month for American soldiers this year. We continue to see thousands of Iraqis killed each month in this country. The President, though he is limited in support for this position, continues to argue that with just a few more American soldiers, a little longer period of time, some more money, everything is going to get better. Many of us are skeptical. The American people believe--and I concur with their belief--we do need a timetable to start bringing American troops home on a responsible, reasonable basis.

I hope the President will reconsider. I hope he will sign this bill. I hope the troops will be funded and the direction of this war will change.

Madam President, this bill is for the Food and Drug Administration's reauthorization. This is an agency which is often overlooked. Madam President, $1.7 billion a year in a Federal budget is not a huge amount of money. There are many other agencies with less responsibility and more resources. The Food and Drug Administration is responsible for really determining the safety of so many things American families take for granted: when you are buying food, when you are buying drugs, when you are buying over-the-counter medicines. Many of the appliances you buy really have to be tested to be safe by the Food and Drug Administration. We count on this small agency to do a very big job and a job that gets bigger by the year.

The bill that is before us is basically the law which authorizes the Food and Drug Administration to do its business. I am glad we brought it to the floor. I salute Senator Enzi on the Republican side and Senator Kennedy on the Democratic side for their leadership.

The Food and Drug Administration is an essential guardian of the public's health and safety in America. In recent years, their reputation has been at risk because of incidents of drug safety problems and questions about their independence. The FDA has been faulted for neglecting its drug safety responsibilities and for failing to respond to concerns raised by its own drug safety specialists.

Experts have warned that the FDA does not have adequate authority to pull dangerous drugs off the market, mandate changes in drug labels, or sanction drug companies that do not monitor drug safety.

The most glaring example of a drug safety problem is the handling of Vioxx, a painkiller that was found to increase the risk of heart attack and stroke and was used by 20 million people across America. Merck was aware--the company that made Vioxx--that product raised the risk of cardiovascular problems, and they continued to market it, nevertheless, long before it stopped selling the drug in 2004. The episode has raised serious questions about FDA's ability to react quickly to signs of safety problems with drugs already on the market.

Listen to what one of FDA's own drug safety experts said in testimony before the Senate Finance Committee. I quote:

I would argue that the FDA, as currently configured, is

incapable of protecting America against another Vioxx. We are

virtually defenseless.

That is quite a statement. It troubles me.

That concern of that individual does not stand alone. A survey of FDA scientists conducted last year by the Union of Concerned Scientists found the following: 47 percent of FDA scientists said their FDA office is less effective than it was 5 years ago; nearly 40 percent said the FDA is not acting effectively to protect public health; more than one- third of FDA scientists said FDA officials care more about approving new drugs and devices than ensuring they are safe; and 15 percent

said they personally have been inappropriately asked to exclude or alter information or conclusions for nonscientific reasons. That is a horrible comment on an agency with the responsibility of the Food and Drug Administration.

Our priority must be to take this reauthorization as an opportunity to change the FDA. The bill does that. It restores balance between timely approval of innovative drugs and safety and effectiveness.

Problems with drug safety in recent years highlight the limits of FDA's ability to monitor and respond to safety problems that arise after approval. Safety problems may not be detected prior to FDA approval because the clinical trials FDA relies upon often involve only a few thousand people.

This bill, S. 1082, responds to this problem by making postapproval monitoring of drugs a core responsibility of the FDA, strengthening and clarifying the tools it has to make their products safer. The bill requires active monitoring for drug safety problems through the use of Federal and private databases. It creates a system for approving drugs with a specific strategy for evaluating and mitigating their risks. It promotes greater transparency by disclosing information on clinical trials.

These and other provisions in this bipartisan bill will help to restore public confidence in the FDA. S. 1082 will help FDA fulfill its crucial and complex mission. I look forward to supporting it.

One of the things most people do not realize is the major responsibility the Food and Drug Administration has for the food we eat.

Now, let me tell you at the outset, I am not capable, having served on Capitol Hill for a few years, to describe to the people who follow this debate what we call the food safety system in America. Imagine, if you will, that we have 12 to 15 different Federal agencies responsible for food safety. Imagine 30 different laws and legal standards for food safety, 40 or 50 different committees on Capitol Hill with jurisdiction, hundreds, if not thousands, of lobbyists and special interest groups hovering over this whole scene. Add to that thousands of Government workers and bureaucrats who are protecting their turf, and we have a system that is virtually out of control--not just when it comes to drugs, as important as they are, but when it comes to the food we eat.

I thank Chairman Kennedy and Senator Enzi and others for partnering with me on an amendment which I will offer as soon as I am given the green light by the chairman and the ranking member on the issue of food safety. I thank them for working with my staff for several months to come up with language to the deal with some serious challenges.

For too long, we have gone without updating the resources and authorities of the FDA in the area of food safety. I think our system has broken down. Now is the time for an appropriate amendment to close some of the gaps we have in our current system.

In the larger picture, I have been working on this issue for a long time. I said, over 10 years ago, we need a single food safety system.

I see Senator Lieberman from Connecticut on the floor. His House colleague, Congresswoman Rosa DeLauro, herself a victim of food poisoning at an early age, has been my ally in this effort. We believe a single food safety system, based on science and not on politics, is the only answer. We need to do that and do it soon.

The amendment which I am going to offer does not reach that level. It does not achieve all of the goals we wanted to on a legal basis, but it moves us forward.

How important an issue is food safety? The Centers for Disease Control estimates that as many as 76 million people suffer from food poisoning each year. Thirty-two thousand Americans will be hospitalized each year for food poisoning; 5,000 will die. With emerging pathogens, an aging population, and an increasing volume of food imports, this situation isn't going to improve without decisive action.

I agree with Chairman Kennedy and Senator Enzi that we should proceed with the broad issue of food safety within general order, and I appreciate their willingness to work with me. The amendment is not what I hoped for in creating a single food safety agency, but it is a step forward.

The most recent news, of course, is about pet food, but believe me, it hasn't been that long ago when we talked about salmonella- contaminated peanut butter and E. coli-contaminated spinach. If it seems as if these food crises are occurring more frequently, they are. We may have the safest food supply in the world, but the fact is, every parent, every family wants to have peace of mind that when they buy something at the grocery store, they can put it on the table, feed it to their family, and no one will get sick. There are questions that are being raised almost on a daily basis about whether we can have that confidence.

The issue that came up recently was on pet food. Batches of wheat gluten and rice protein concentrate contaminated with a chemical called melamine were imported from China by several shipping companies. We just learned over the last few days from stories printed in the press that melamine is regularly added to animal feed in China.

Why would they add a chemical called melamine to something they are going to feed to livestock? Well, it is a way to increase the value of the product. If there is more protein in the feed, then they can charge a higher price. When the food product is tested to see if there is protein, you look for the presence of nitrogen. The chemical, melamine, when added, tests for higher nitrogen levels, therefore they argue higher protein levels, therefore they argue they should be paid more. So it is an economic fraud. They have argued that this is a product that doesn't hurt people. We are not sure of that, but we do know that the animals that died as a result of contaminated pet food, some of them were found to have melamine in their system. It is a serious question as to whether it is toxic.

We know now that this pet food contamination has resulted in the deaths of more than 4,000 animals across America. This contaminated product came into America without inspection or without suspicion. The FDA did not have a memorandum of understanding with China or a certification that their standards for food safety were even close to those of the United States. The product made its way from the importer ChemNutra into various manufacturers of pet food. Menu Foods is a Canadian company. They make pet food under a dozen different labels. They learned on February 20 there was a problem. How did they know there was a problem? The cats and dogs told them. They stopped eating their food and they started getting sick.

So you own a company that has dozens of different pet food labels, and you notice that animals are getting sick. What is the responsible thing for a company to do at that time? Pull the product off the shelf and notify the Federal Government. They waited 3 weeks before they sent out a notification. By the time the Food and Drug Administration learned about this, there were millions of cans of pet food and other products under different labels spread all across America with this contaminated product. Three weeks they waited. Why? Because the law does not currently require them to report on a timely basis.

I asked the FDA last week: What is the penalty against Menu Foods for waiting 3 weeks? They said: Well, we are considering. We are talking to our counsel. We will get back to you. Months have passed. Nothing has happened. Menu Foods waited 3 weeks instead of reporting on a timely basis. By then, the product was all across America.

In the case of rice protein concentrate, there is less certainty. Importer Wilbur Ellis purchased product from the Binzhou Futian Company in China. It then distributed the product to a host of companies that produce pet food. These brands and labels have been recalled in a haphazard way over the past 3 weeks--again, delays in reporting. The FDA has even refused to name several companies for more than a week trying to get to the bottom of this investigation because the records process is so broken down at this agency.

One or more of the manufacturers sold some refuse pet food that it produced using contaminated product to hog farms in California and other States. These farms fed their hogs the

contaminated feed, some of which was sold to consumers and much more of it has been quarantined and is slated for destruction.

In addition, we just learned this week that 38 poultry farms in Indiana received contaminated feed. So the plot thickens, and the safety issue grows as we wonder if what was originally pet food is now being fed to livestock, and if humans consume the food what impact it will have.

There is a mystery importer involved as well from China that we have heard about but we can't identify yet. Supposedly this second importer purchased rice protein from the Chinese firm in question in larger quantities than the firm Wilbur Ellis.

In terms of the investigation in China, the FDA said: We want to send inspectors to China to see what they are sending to us. Well, first the Chinese said: We deny you the visas for your FDA inspectors. Imagine that. Millions of dollars worth of foodstuffs coming in from China, contaminated and poisoned, killing off pets, threatening human consumption, and when we say to the Chinese that we want to take a look at their production facilities, they denied us visas. I joined with Congresswoman DeLauro and sent a letter to the Chinese Embassy, and they reversed their position, offering the visas. We have to make it clear to China and every other country that if they want to do business with the United States, they will do it on our terms when it comes to health and safety. We will never allow them to compromise the safety and health of American citizens in the process.

The amendment I am going to offer--and I hope it will be accepted-- does several things based on what we have learned over the last 6 weeks. First, during this recall, consumers, veterinarians, and retailers, among others, expressed concern about the scope of the recall, what products were included, or what not to feed to domestic animals. The FDA was slow, uneven, and inconsistent in sharing information on the recall. While there are mechanisms in place to proactively track human food-borne illnesses and then share information, no similar system exists for companion animals.

I visited the FDA pet food recall Web site the day before the March 12 Agriculture appropriations hearing and found a jumble of corporate press releases. It was virtually unintelligible. I said to the FDA: Can't you make this information clearer so consumers can have the information they need to purchase these products? They took it to heart and made the changes. That is good.

In addition, following the recall, the FDA checked the records of companies such as Banfield, the largest privately owned veterinary hospital chain in the United States. The records kept showed a statistically significant increase in the instances of renal failures of cats. A system in place to track these events might have caught something like melamine earlier. So the amendment creates an early warning and surveillance system for companion animals and directs the Secretary to work with professional organizations, veterinarians, and others to disseminate information.

While we are at it, the amendment would direct the FDA, in cases of both pet food and human food, to keep up-to-date, comprehensive, searchable recall lists on their Web site.

Second, the amendment closes the gap that FDA itself identified in an earlier draft framework posted on its Web site in December of 2006. The guidances and practices that govern the pet food industry are currently generated by the American Association of Feed Control Officers, known as AAFCO. The guidelines on best practices and ingredient lists are updated annually and implemented on a voluntary basis by manufacturers and State departments of agriculture. However, there is no requirement under the law for States to adopt these practices, and they don't have the force of Federal guidelines. Inspections are not coordinated State to State, and some States have different standards. While the FDA participates in the AAFCO process, it does not provide a list of ingredients and additives. AAFCO's list is more comprehensive than the FDA's. Our amendment would direct the FDA to work with AAFCO and other stakeholders to give these guidelines the force of law.

Third, the amendment closes a loophole that this contamination has exposed with regard to our imports of food. The source of the contamination we know of was wheat gluten and rice protein concentrate originating in China. Neither shipment was inspected by the FDA. If you have some peace of mind or belief that a Federal inspector is watching food as it comes into the United States, the odds are 99 to 1 you are wrong. Only about 1 or 1.5 percent of all the shipments of food products coming into the United States are actually inspected.

As imports have increased the number of inspectors have decreased. This is an indication of U.S. food imports by country. As you can see, there have been dramatic increases in these fiscal years showing that the amount of food coming into the United States is increasing in volume. The number of inspectors who watch for this food to protect our families and consumers across America just hasn't kept pace.

In 2003, the United States imported $45.6 billion worth of agricultural products--in 2003; today, $64 billion. Agricultural imports from China have almost doubled in that period of time, from $1.2 billion to $2.1 billion. Due to flat budgets and increasing responsibilities, the overall number of FDA inspectors looking at these shipments and at domestic food processors has actually decreased from 2003 to the present time; imports up, inspectors down.

Are we surprised at what has happened? The FDA doesn't have the resources or the authority to make sure what we are bringing in from overseas is safe. We need to tackle it in a larger bill.

What our amendment does is close the loophole by improving data collection and reporting. It creates an FDA database of food adulterants that would be filled by FDA inspectors as well as importers of food. The extra series of data points would better pick out trends and help FDA do a better risk-based inspection job. It also creates a system in which adulterations are reported quickly so as to prevent contamination from spreading. This would have helped in this most recent case, but because of delays in reporting it led to an expansion of recalled product into dozens of different companies and got perilously close to the human food chain. The data would then be used by the Secretary to issue import alerts, blocking similar risky products.

I have also pursued a separate track on the issue of resources for FDA by sending a letter to Chairman Kohl of Wisconsin and Senator Bennett of Utah requesting additional resources for food inspection at the Food and Drug Administration. I hope my colleagues will join me in that effort.

Also, I am filing an amendment that would authorize a study on user fees for food producers. It is vital that we explore various revenue streams for the FDA in light of the shortage of resources they have for inspection.

The last two items in my amendment are a sense of the Senate and a clarification that companies are required to maintain records and make them accessible to the FDA as part of an investigation. This latter item would prevent delays that keep contaminations from being known as quickly as possible. In the case of recalled peanut butter this past winter, an FDA report showed that inspectors were denied documents when they were requested. The language would clarify that when the FDA makes the inspection, it will have access to those documents needed for purposes of safeguarding the food supply.

The sense-of-the-Senate language goes beyond this amendment and this bill, stating that it is vital to update resources, direction, and authorities of the FDA to better safeguard our food supply. The sense of the Senate directs the FDA to work with our trading partners to establish cooperative agreements.

Several weeks ago, Robert Brackett, Director of the FDA's food arm, said:

These outbreaks point to a need to completely overhaul the

way the agency does business.

I am thankful the sponsors of this legislation for the reauthorization of the Food and Drug Administration understand that expanding the scope of our debate on this bill to include food safety is overdue.

Mr. Brackett went on to say:

We have 60,000 to 80,000 facilities that we are responsible

for in any given year. We have to get out of the 1950s

paradigm.

Dr. Stephen Sundlof, Director of the Center for Veterinary Medicine of FDA, which has jurisdiction for pet food, implied as much when he was quoted last month as saying:

In this case, we're going to have to look at this after the

dust settles and determine if there is something from a

regulatory standpoint that we could have done differently to

prevent this incident from occurring.

I couldn't agree more. This is a situation where we need one food safety agency, not driven by the politics of Washington but driven by science, to make sure the food fed to our children, the food fed to our pets, or any food served in America is as safe as possible. As we import more food with fewer inspectors, the risk increases.

I might add that we have looked at the pet food contamination and others from the aspect of greed and negligence. In the instance of China, they were adulterating their product with a chemical so that it was worth more in the marketplace. That is economic fraud. In the instance of spinach and peanut butter, we are dealing with negligence-- negligence that results in a deadly product being sold across America. But we can't stop there, unfortunately. In the world we live in, with the vulnerabilities we have, food could also become a terrorist weapon. That may sound far-fetched to some, but when Governor Tommy Thompson left the Bush Cabinet, he said in parting that he found it hard to imagine why the terrorists had not attacked our food supply. He said he worried about it on a regular basis.

We have to have inspection standards in place that mitigate against greed and negligence and the possibility of someone intentionally contaminating our food supply, causing terrible suffering and death across America.

That is why this amendment is a step in the direction for a safer food supply. I sincerely hope my colleagues on both sides of the aisle will support my efforts.

I yield the floor.

Mr. President, about 1 hour ago, the President of the United States vetoed the supplemental appropriations bill for the war in Iraq. It was a bill that we have worked on in Congress since its arrival in the middle of February. It was the subject of lengthy deliberations. There were long debates on the floor of the House and Senate. There was a lot of compromise that led to the final work product and a bipartisan vote which sent it to the President.

There were people who were skeptical as to whether the Senate and the House

of Representatives could rise to this challenge. In a nation that is so divided on so many political issues, in a nation where the war in Iraq is the biggest issue by far, there were serious doubts as to whether this Congress, with scant majorities of Democrats in both the House and the Senate, could produce a bill for President Bush to consider.

Congress rose to that occasion. With the leadership of Speaker Pelosi and the leadership of our majority leader, Harry Reid of Nevada, we produced a bill which attracted not only the overwhelming support of the Democratic caucus but also the support of Republican Senators who joined us in passing this bill.

It was our hope that our work product would be considered seriously by the President. It was sent to him this afternoon. A few hours after receiving it, the President vetoed it and announced his veto in a public press conference.

I am disappointed. The President had a chance to sign a bill that would have funded the troops in this war. More importantly, it was a bill he could have signed which could have changed the course of this war--something that is long overdue.

I listened in my office as the President gave his veto message to the American people. It was short, direct but, in many ways inadequate when you consider the awesome responsibility we face in Congress and in the White House.

The President referred to our timetable to start bringing American troops home as a date for failure. It is ironic the President would make that statement on the fourth anniversary of his appearance on the USS Lincoln aircraft carrier under a banner announcing, 4 years ago, that our mission was accomplished. For the President to announce success and failure, accomplishment and lack of accomplishment, leaves something to be desired after that experience 4 years ago.

I am particularly troubled as well by the President's notion of what this bill was all about. You see, he said, at one point, for us to set a timetable to bring American troops home would--in the President's words--``demoralize the Iraqi people.'' Those were his words.

Mr. President, excuse me, but I am not as interested in building up the morale of the Iraqi people as I am in inspiring the leaders of the nation to stand up and lead. For too long now, with the protection of the U.S. troops, this Iraqi Government has failed to make even basic progress in taking control of their country. They have failed to address the key political issues that would lead to stability.

So the President is arguing that if we continue to send 150,000 or more American soldiers to risk their lives, it will build up the morale of the Iraqi people to seek nationhood, stability, and peace. So we expect American soldiers to stand in this crossfire of a bitter religious and civil war, hoping that the Iraqi people will be inspired enough to ask their Government for leadership?

Mr. President, 3,351 American soldiers have fought and died in Iraq, as I stand here today. Mr. President, 3,351 American lives should be enough to inspire the Iraqi people and their Government. How many more American lives will it take for that inspiration the President is looking for?

I am troubled by this notion that unless we will sacrifice our treasure and the lives of our brave soldiers, the Iraqis cannot rise to the occasion and lead themselves out of this morass.

I also listened to the President when he characterized the money that we added in Congress to his budget request. He called it--and I will quote--``billions in nonemergency spending that has nothing to do with fighting the war on terror.''

I wonder if the President's staff put the bill in front of him for him to take a close look at, in the few hours he had it before vetoing the bill.

Is the President arguing to the American people that providing $2 billion more in equipment to keep our troops safe in Iraq has nothing to do with fighting the war on terror?

Is the President arguing that the $1 billion in our supplemental appropriations bill--the $1 billion to replenish National Guard equipment destroyed and lost in the war in Iraq--that $1 billion has nothing to do with the war on terror?

Is the President arguing that the $2 billion in this bill for military hospitals--such as Walter Reed, so we do not relegate our fallen soldiers and those who were injured to a flophouse motel across Georgia Avenue from Walter Reed Hospital--is he arguing that the $2 billion that is in the bill for military hospitals has nothing to do with the war on terror?

Perhaps the President is not aware of the fact there was $2 billion in this bill for veterans hospitals all across America, for those who have come home with post-traumatic stress disorder, traumatic brain injury, and amputations who need the services of the VA hospitals. Is the President arguing that money for VA hospitals has ``nothing to do with the war on terror''? That is what he said. That is an exact quote.

This bill has add-ons that relate to real emergencies in America. I have outlined a few related directly to the war on terror, directly to our troops, directly to our national security.

There is money, as well, for the base closing commission, which it is my understanding the President wanted included. There is money, as well, for Hurricane Katrina. Here we are, a year and a half after that terrible tragedy, still trying to put New Orleans back on its feet and rebuild Louisiana and Mississippi and areas affected by Katrina and Rita. Yes, there is money in the bill for those emergency purposes.

For the President to dismiss this as billions in nonemergency spending suggests his staff did not do their job, they did not spell out to the President what was in that bill before he vetoed it.

Well, the President knows--and he said as much--we do not have the votes to override his veto. That is a reality. It takes 67 votes in the Senate. We have been able to rally 51 or 52 votes on a good day to question the President's policies in Iraq. Two or three Republican Senators have stood by our side on the Democratic side of the aisle. Few others have been willing to do so. So the thought of reaching 67 votes is probably a bridge too far. I think we know that reality.

But this much I will say: Congress cannot override the President's veto, but the President cannot override the reality of Iraq. The reality of Iraq is this: We are in the fifth year of a war. We have seen 3,351 American lives sacrificed, 25,000 or more injured, 7,000 or 8,000 seriously injured with traumatic brain injury and amputations.

Americans have sacrificed from their hard work and earnings $500 billion for this war and for rebuilding Iraq. That is the reality of Iraq today.

The reality is, this last month of April was the deadliest month this year for American soldiers. The reality is, this President has no plan to exit that country and bring our troops home. That is the reality. We may not be able to override this veto, but the President cannot override those realities.

Now it is time for the American people to understand what happens next.

We will fund these troops. We have made that promise, and we will keep it. They will not be bargaining chips in our policy debate in Washington. But we will continue, through this bill and through other legislation this year, to continue to put the issue of the Iraq war in front of the President, in front of the American people. They expect nothing less.

For those who are frustrated by the President's veto today, I join them in that frustration. But I join them, as well, in believing that as the American people speak out on this issue, the likelihood that Republicans will cross this aisle and join us increases.

The time will come--I am not sure when but I hope soon--that tipping point will be reached where the Republicans finally say to their President: Enough. We cannot ignore the reality of this war and what it has done to America. Then they will join us. Then this will truly become a bipartisan effort. Then we will be able to override vetoes and pass legislation that will make a meaningful change in the policy of this war.

I encourage those across America seeking a new direction in Iraq, do not be discouraged by this veto. There will be another day. There will be another bill. There will be another chance for us to change this policy. We need to keep our forces together--the forces for change in Iraq on the Democratic side and on the Republican side. We cannot allow the President's veto pen to be the

last word on this war in Iraq. We have to stand together, and we have to work together.

The President comes up with rosy reports on what is happening in Iraq. But we know the reality. Sectarian deaths are down, he said. Well, I guess they are down slightly, a small percentage, of those innocent civilians killed last month. There were fewer this month. I guess that is progress. But those who are there say the violence is subsiding while the surge is underway, and they are afraid it will return. I am, too.

We need to pass a bill for the troops, and sometime soon. We will work hard to try to find a way with the President. He has invited the leadership of the Senate and the House to meet with him tomorrow in the White House. I have been to those meetings before. There have been little results to point to for the time we have met and the dialog we have exchanged. But I go tomorrow with the hope that things will be different. I hope this President, after his moment in the sun with this veto, will now understand that we face the grim reality of Iraq, and the reality that we have no exit plan. This failed policy in Iraq must come to an end. We will continue to fight, with this democratic Congress, to make a change in that policy. We will stand by our soldiers, but we will not stand by a failed policy. I am encouraged by the fact that so many of my colleagues are ready to continue this fight, and I encourage the American people: Don't give up. Don't lose heart. This democracy works when you work with us to bring the will of the people to the law of the land.

Mr. President, I yield the floor.

Mr. President, it has been more than 200 years since Lewis and Clark first laid eyes on Mount Hood. Today, I propose, with Senator Smith, that the spectacular mountain, seen first by our pioneers, should be preserved for all time.

The Lewis and Clark Mount Hood Wilderness Act of 2007, which we introduce today, is similar to the bill Senator Smith and I introduced in the last Congress. It does include several improvements that came about from comments and constructive suggestions

from a variety of groups at home in Oregon.

The legislation also includes input from the Energy and Natural Resources Committee. We appreciate their input and believe their views can help speed the bill's passage.

In tribute to the great river-dependent journey of Lewis and Clark, our legislation adds nine free-flowing stretches of rivers to the National Wild and Scenic River System. This reflects the views of Oregonians, but, frankly, I hear it from folks in the Midwest, where the Presiding Officer lives, and from people from every nook and cranny in this country who have all come to treasure our spectacular mountain.

This legislation contains a number of provisions of the original Mount Hood legislation I introduced in 2004. The bill protects the lower elevation forests surrounding Mount Hood and the Columbia River Gorge as Lewis and Clark saw them. These forests embody the natural beauty of our home State. They provide the clean water necessary for the survival of threatened steelhead, Coho, and Chinook salmon. They provide critical habitat and diverse ecosystems for elk, deer, lynx, and the majestic bald eagle. These are the forests that provide unparalleled recreational opportunities for Oregonians and the scores and scores of visitors we get from Minnesota and every other part of the country as well.

But the legislation I offer today with Senator Smith differs from the bill I introduced several years ago because it responds to the many comments we have heard. We have received thousands of comments on our proposed legislation. Some comments came as a result of the general public meetings I held at home in Oregon. Many of the meetings lasted over 3 hours. Everybody who wanted to speak was given the opportunity to do so. Other comments came from the second Mount Hood summit that was held at Timberline Lodge, hosted by Congressmen Walden and Blumenauer. My staff and I met with over 100 community groups and local governments, the members of the Oregon congressional delegation, the Governor, and the Bush administration. More comments came from calls and letters from Oregonians who are saying that now, now, now is the time to preserve Mount Hood.

Overwhelmingly, these comments have urged that we build on Oregon's wilderness system. This goal is as important today as it was in 1804, when Lewis and Clark first viewed Mount Hood; in 1964, when the Wilderness Act was passed; or in 1984, when wilderness protections were last designated on Mount Hood. It is time to plan now to protect this treasure for future generations.

The Mount Hood National Forest is the seventh most visited national forest in our country. In the 22 years that have elapsed since any new wilderness has been designated on Mount Hood, the population in the local counties has increased significantly--25 percent in Multnomah County, 24 percent in Hood River County, and 28 percent in Clackamas County.

The predominant public use of this urban forest is nonmechanized activities such as hiking, camping, and fishing. With increasing emphasis on wild scenery, unspoiled wildlife habitats, free-flowing rivers, wilderness, and the need for opportunities for diverse outdoor recreation, sometimes it seems we are in jeopardy of loving our wild places to death. We all see Americans coming together to make sure the most special places are protected for future generations.

A few years ago, the Forest Service made a proposal to limit the number of people who could hike on the south side of Mount Hood. Suffice it to say, the public outcry in opposition was enormous. It seems to me, rather than tell people they are going to be restricted from using our public lands, part of the solution for Mount Hood lies in providing more opportunities for them to enjoy the mountain's great places. We ought to ensure that the Mount Hood National Forest can meet the increased demand for outdoor experiences, and the legislation I offer today with Senator Smith provides these opportunities. Hundreds of people spoke at the public meetings I held throughout the State. I have received 2,500 written comments urging additional wilderness on Mount Hood. There are a few key areas the citizens continually come back and refer to:

First, by astonishing numbers, they want to see additional wilderness on Mount Hood. A large number of Oregonians didn't think enough wilderness had been included, for example, in the legislation that was considered by the other body.

A second area is mountain biking. Some mountain bikers expressed concern that their recreation opportunities not be unfairly curtailed. Senator Smith and I had many discussions with them to ensure that would not be the case.

Third, fire protection and forest health was something referred to by many Oregonians. Citizens were concerned about the health of the forest. Those living in towns on the mountain and the gorge were concerned about fire protection in their communities, and we sought to address those issues as well.

An additional concern was developed recreation, with some citizens worried about maintaining a role for developed recreation, such as skiing, on Mount Hood.

In each of these areas, Senator Smith and I tried to follow up and be responsive to what citizens at home were saying.

With respect to additional wilderness, there are currently 189,200 acres of designated wilderness in the Mount Hood National Forest. This bill increases wilderness on Mount Hood by designating approximately 128,000 acres of new wilderness.

The bill adds the areas surrounding the oldest Mount Hood wilderness--the mountain itself--which was designated in the original Wilderness Act of 1964. These additions include cathedral old growth forests, special trails, lava beds that were created during the Mount Hood eruptions, and much of the legendary route that Oregon's pioneers used when they came to our great State.

To the north and west of the mountain, we add the viewshed of the Columbia Gorge to the current Mark O. Hatfield Wilderness. These areas encompass the spectacular ridges that frame the gorge that we marvel at from I-84 and include perhaps the greatest concentration of waterfalls in all of North America.

To the southwest of the mountain, we add lands to the current Salmon Huckleberry Wilderness to conserve their diverse wildlife and protect unique recreational areas such as those around the extremely popular Mirror Lake. These lands include Alder Creek, the source of drinking water for the city of Sandy, and that city unanimously endorsed the draft proposal.

Over to the east are proposed additions to the Badger Creek Wilderness area. These areas provide a critical link between westside forests and eastside ecosystems. This area is known for its spectacular colors in the fall and the best deer and elk hunting in our entire Mount Hood National Forest.

Among the areas we are protecting is the newly designated Richard L. Kohnstamm Memorial area. It is dedicated in honor of Mr. Kohnstamm who restored the historic Timberline Lodge built originally by the Works Progress Administration in 1937. Our new 2007 bill adds 2,730 acres of Marion County lands in the Bull of the Woods Wilderness Additions, while removing lands where users identified potential conflicts.

Second, in the area of wild and scenic rivers, we protect over 79 miles of wild and scenic rivers on nine free-flowing rivers. This protects some of the most pristine rivers in our State. Among those proposed rivers are the picturesque waterfalls and glacial outwash of the East Fork of the Hood River, and the ancestral hunting and fishing grounds of Fish Creek. Over 17 miles of extraordinary salmon and steelhead habitat on the Collowash River have also been added for protection under our legislation.

Mountain biking is an area where there has been a lot of debate. We believed the local riders raised valid concerns, and we took two steps. First, we proposed the Mount Hood National Recreation Area. This area was so popular in our last bill that Senator Smith and I decided to greatly expand it to include 34,640 acres, an increase of over 16,000 additional acres. It is going to offer permanent environmental protection to those beautiful areas, while

providing mountain bikers, recreational users, and others an opportunity to enjoy recreation on the mountain.

Additionally, I made boundary adjustments to ensure that all open mountain biking trails were not included in this proposed legislation.

With respect to fire protection and forest health, we tried to make clear that where there are healthy, older trees, they should not be harvested on Mount Hood or in the gorge. Older healthy stands are most resistant to fire and disease. However, there is an enormous backlog of overcrowded plantation, second growth that really ought to be thinned. The legislation includes provisions that would give the Forest Service a mandate to prepare an assessment for promoting forests resilient to fire, insects, and disease. This also includes provisions to study and encourage the development of biomass in conjunction with forest health work.

We happen to think that biomass is one of the most exciting new fields for Oregonians to get into. The opportunity to generate clean energy, help small rural communities, create family wage jobs, is something that we should not miss out on. This legislation tries to tap the potential for progress in the biomass field as well.

Finally, we add fire-safe community zones so that the Secretary of Agriculture will construct a system of fire-safe buffer zones around the communities of Cascade Locks and Government Camp.

With respect to developed recreation, we wanted to facilitate recreational opportunities in this area and thus adopted a provision that came from the other body known as ``fee retention'' that would establish a special account for the Mount Hood National Forest.

In addition, in order to help address growth while ensuring access to recreational opportunities, we have adopted provisions originally coming, again, from language from the other body directing the Secretary of Agriculture and the State of Oregon to develop an integrated transportation plan for the Mount Hood region.

I commend particularly my colleague in the other body, Congressman Blumenauer, one of the real pioneers in thinking about transportation.

Finally, with respect to key relationships with our tribes and our local governmental bodies, we have incorporated provisions on local and tribal relationships, emphasizing the rich history of the Mount Hood area and affirming the rights of Native peoples to access the mountains as they have for generations.

The protections of these important Oregon places is going to depend on the hard work and dedication of all Oregonians. I am very pleased--I am summing up, and the Senate has been patient in giving me this extra time--to say that this has been a bipartisan effort by the Oregon congressional delegation. Senator Smith joins me in introducing this legislation. We believe this brings together our county commissioners, entrepreneurs, environmentalists, Chamber of Commerce, State-elected officials, the Governor. All of those who feel so strongly about protecting Mount Hood rolled up their sleeves, went to work, and joined myself and Senator Smith to try to find common ground to make sure that Mount Hood would be protected for all time.

We are looking forward to perfecting the legislation together in the coming weeks and looking forward to seeing a swift adoption by Congress.

The grandeur of Mount Hood and our special treasures is pretty much in the chromosomes of Oregonians. Protecting our treasures is something about which we feel so strongly. Today is a special day for us because, once again, the citizens of our State have come together and have worked with myself and Senator Smith to take action to protect our treasures.

Mr. President, Oregon's Mount Hood is a cherished State treasure. This wild place is often photographed, visited and enjoyed by scores of Oregonians and non-Oregonians. Today, I am introducing, along with my colleague Senator Smith, a bi-partisan Oregon Wilderness bill: the ``Lewis and Clark Mount Hood Wilderness Act of 2007.'' This bill is similar to the one Senator Smith and I introduced in the last Congress, but it includes several improvements that resulted from comments received from stakeholders. The bill also includes input from the Energy and Natural Resources Committee, which we hope will help speed the bill's passage. In tribute to the great riverdependent journey of Lewis and Clark, our legislation adds nine free-flowing stretches of rivers to the National Wild and Scenic River System. This reflects the Oregonian wish to protect but also actively experience our State's treasures.

This bill contains many elements of the Mount Hood bill I introduced in 2004, while also incorporating many new provisions to protect and improve the Mount Hood region. This bill protects the lower elevation forests surrounding Mount Hood and the Columbia River Gorge as Lewis and Clark saw them. These forests embody the natural beauty of Oregon. They provide the clean water necessary for the survival of threatened steelhead, Coho and Chinook salmon. These forests provide critical habitat and diverse ecosystems for elk, deer, lynx and the majestic bald eagle. And these are the forests that provide unparalleled recreational opportunities for Oregonians and our visitors.

But the bill I introduce today differs from the bill I introduced 2 years ago because it responds to the many comments I heard in the ensuing years. I received thousands of comments on proposed Mount Hood legislation. Some comments came as a result of the general public meetings I held in Oregon. Many of the meetings lasted over 3 hours, and everyone who wanted to speak was given an opportunity to do so. Other comments came from the second Mount Hood Summit held at Timberline Lodge hosted by Representatives Walden and Blumenauer. I and my staff met with over 100 community groups and local governments, the members of the Oregon congressional delegation, the Governor, and the Bush administration. And still more comments came from letters and phone calls from Oregonians.

Overwhelmingly, these comments urged me to protect and build on Oregon's Wilderness system. This goal is as important today as it was in 1804, when Lewis and Clark first viewed Mount Hood, 1964, when the Wilderness Act was passed, or 1984, when wilderness protections were last designated on Mount Hood--if not more so. To succeed, we must provide the tools that help us create a planned future on Mount Hood. This bill does both.

The Mount Hood National Forest is the seventh most visited National Forest in the United States. In the 22 years that have elapsed since any new wilderness has been designated in the Mount Hood area, the population in local counties has increased significantly--25 percent in Multnomah County, 24 percent in Hood River County, and 28 percent in Clackamas County.

The predominant public use of this urban forest is non-mechanized activity like hiking, camping, and fishing. With increasing emphasis on wild scenery, unspoiled wildlife habitats, free flowing rivers, wilderness and the need for opportunities for diverse outdoor recreation, sometimes it seems we are in jeopardy of ``loving our wild places to death.''

A few years ago, the Forest Service made a proposal to limit the number of people that could hike the south side of Mount Hood and the public outcry was enormous. Seems to me, rather than tell people that they are going to be restricted from using our public lands, part of the solution for the future of the Mountain lies in providing more opportunities for them to enjoy the Mountain's great places. We should ensure the Mount Hood National Forest can meet the increased use and demand for outdoor experiences--my bill will provide those opportunities.

Of the hundreds of people who attended the meetings I held throughout the State of Oregon, the vast majority spoke in favor of more wilderness. Additionally, I have received more than 2,500 written comments supporting additional wilderness for Mount Hood.

This is what I have heard: First and foremost, I heard that Oregonians in astonishing numbers support protecting Mount Hood and the Columbia River Gorge with additional wilderness. A large number of Oregonians didn't think that enough wilderness areas had been included in the House proposal.

Some mountain bikers expressed concerns that their recreation opportunities not be unfairly curtailed.

Some people were worried about forest health, and those living in towns on the mountain and in the gorge were concerned about fire protection for their communities.

Some people were worried about maintaining a role for developed recreation, like skiing, on Mt. Hood.

This is what my bill does to address those concerns: There are currently l89,200 acres of designated wilderness in the Mount Hood National Forest. This bill increases wilderness on Mount Hood by designating approximately 128,600 new acres of wilderness.

This bill adds the areas surrounding the oldest Mt. Hood Wilderness-- the mountain itself--which was designated in the original Wilderness Act of 1964. These additions include cathedral old growth forests, the historic Tilly Jane trail, lava beds that were created during the Mt. Hood eruptions, and much of the legendary route that Oregon's pioneers used when they were settling our great State. To the north and west of the mountain, I would add the viewshed of the Columbia Gorge to the current Mark O. Hatfield wilderness. These areas encompass the spectacular ridges framing the Gorge that we all marvel at from 1-84 and include perhaps the greatest concentration of waterfalls in North America. To the southwest of the mountain I add lands to the current Salmon Huckleberry Wilderness to conserve their diverse wildlife and protect unique recreational areas like those around popular Mirror Lake. These lands include Alder Creek, the source of drinking water for the City of Sandy, which unanimously endorsed the draft proposal. Over to the east are proposed additions to the Badger Creek Wilderness. These areas provide a critical link between Westside forests and Eastside ecosystems. This area is known for beautiful fall color and the best deer and elk hunting in the entire Mount Hood National Forest. Among the areas we are protecting is the newly designated Richard L. Kohnstamm Memorial Area. It is dedicated in honor of Mr. Kohnstamm who restored the historic Timberline Lodge--built originally by the Works Progress Administration in 1937--to its former grandeur. Our new 2007 bill adds 2730 acres of Marion County lands in the Bull of the Woods Wilderness Additions, while removing lands where users identified potential conflicts.

My proposal seeks to protect over 79.6 miles of wild and scenic rivers on nine free flowing rivers. This includes some of the most pristine and beautiful rivers in Oregon. Among those proposed rivers are the picturesque waterfalls and glacial outwash of the East Fork of the Hood River, and the ancestral hunting and fishing grounds of Fish Creek. Over 17 miles of superb salmon and steelhead habitat on the Collowash River have also been proposed for protection.

I believe that local riders raised some valid concerns, so I did two things. I have proposed Mount Hood National Recreation Area. This area was so popular in our last bill that Senator Smith and I decided to greatly expand it to include 34,640 acres--an increase of over 16,700 acres. It will offer greater, permanent environmental protections to those beautiful areas, while providing mountain bikers and other recreational users an opportunity to continue to recreate in these areas. Additionally, I made boundary adjustments to ensure all open mountain biking trails were not included in my proposed wilderness.

I protect wilderness, where there are healthy, older trees that should never be harvested on Mount Hood or in the Gorge. Older, healthy stands are the most resistant to fire and disease. However, there is an enormous backlog of over-crowded, plantation, second-growth that should be thinned. My bill includes provisions that would give the Forest Service a mandate to prepare an assessment for promoting forests resilient to fire, insects and disease. This also includes provisions to study and encourage the development of biomass in conjunction with forest health work. In addition, I added fire safe community zones so that the Secretary will construct a system of fire safe buffer zones around the communities of Cascade Locks and Government Camp.

In order to facilitate developed recreation opportunities, I have adopted the House provisions establishing a ``feeretention'' provision that will establish an account for the Mount Hood National Forest. In addition, in order to help address growth while ensuring access to recreational opportunities, I have adopted provisions, originally coming from the language passed in the House last Congress, directing the Secretary and the State of Oregon to develop an integrated transportation plan for the Mount Hood region.

I have also incorporated provisions on local and tribal relationships emphasizing the rich history of the Mount Hood region and affirming the rights of Native peoples to access the mountain's resources, as they have for generations.

The protection of these important Oregon places will depend on the hard work and dedication of all Oregonians and particularly that of my Oregon colleagues here in the Congress. I am especially pleased that Senator Smith has joined me in developing this bipartisan legislation and putting forth our proposal for wilderness. I am hopeful everyone will pull together: county Commissioners, environmentalists, entrepreneurs, chambers of commerce, State elected officials, the Governor, and the Oregon delegation here in the Capitol. I look forward to perfecting legislation together in the coming weeks, and seeing its swift adoption by Congress thereafter. Then the grandeur of Mount Hood and other Oregon treasures can be assured for future generations.

I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, today I am introducing the ``Competitive and Fair Agricultural Markets Act of 2007.'' Cosponsors joining me in introducing this legislation are: Senators Enzi, Feingold, Thomas, Dorgan, Baucus and McCaskill. This legislation seeks to level the playing field for agricultural producers by strengthening and clarifying the Packers and Stockyards Act of 1921 and the Agricultural Fair Practices Act of 1967 and strengthening enforcement of both laws by USDA. I intend to use this legislation as the basis for developing a proposed competition title in the new farm bill this year.

Consolidation is happening in all sectors of agriculture and having a negative effect on producers and consumers across the Nation. Consolidation in itself is not a violation of the Packers and Stockyards Act, but when some entities become larger and more powerful that makes enforcement of the Packers and Stockyards Act absolutely critical for independent livestock and poultry

producers. The statistics speak for themselves. For example, today, only four firms control 84 percent of the procurement of cattle and 64 percent of the procurement of hogs. Economists have stated that when four firms control over 40 percent of the industry, marketplace competitiveness begins to decline. Taken together with fewer buyers of livestock, highly integrated firms can exert tremendous power over the industry.

The Grain Inspection, Packers and Stockyards Administration, GIPSA, at USDA has the responsibility to enforce the Packers and Stockyards Act. This Act is critical, and protects livestock producers from unfair, unjustly discriminatory and anti-competitive practices in the marketplace. For years I have had my doubts about whether USDA was serious about enforcing the Packers and Stockyards Act. In 2005, I requested an audit by USDA's Inspector General to investigate USDA's oversight, and enforcement of the law. Last year, the Inspector General confirmed the concerns I had and uncovered even more systemic problems. The report described widespread inaction, management of the agency actively blocking employees from conducting investigations into anti- competitive behavior and a scheme to cover up the lack of enforcement by inflating the reported number of investigations conducted.

That is why today, the legislation I introduce will reorganize the structure in how USDA enforces the Packers and Stockyards Act and create an office of special counsel on competition matters. The special counsel would be appointed by the President with advice and consent from the U.S. Senate. Some would argue that Senate advice and consent is not needed. However, for over five years, GIPSA failed to move competition investigations forward and no one above the level of deputy administrator at GIPSA seemed to have any idea that any problems were going on, despite the fact I was sending letters to the Secretary of Agriculture pointing out that USDA was failing to enforce the law.

In the past year, GIPSA has worked in good faith to improve its enforcement activities. However, GIPSA only investigates potential violations of the law, they do not litigate and follow-through with the investigation to the end. Litigating cases is reserved only for USDA's Office of General Counsel, OGC, unless they refer it to the Department of Justice.

USDA's Office of General Counsel has not been active on cases involving anti-competitive practices in recent years since GIPSA was not referring cases to them. To be sure, only two cases involving anti- competitive practices were referred to OGC in 5 years. But there are concerns that OGC is not as committed to enforcing competition investigations as they should be. This lack of commitment was clearly evident last year in testimony provided by OGC Assistant General Counsel in the Trade Practices Division at a hearing by the Senate Committee on Agriculture, Nutrition, and Forestry.

Concerns about OGC's attitude toward enforcing the Packers and Stockyards Act are not new. USDA's Inspector General stated in its 1997 audit that Packers and Stockyards program officials were concerned that OGC did not want to litigate competition cases ``because they are complicated and time consuming'' and OGC had ``limited expertise'' with them. In 2000, the Government Accountability Office found ``disagreements'' between OGC and GIPSA regarding the interpretation of the Act's competition provisions. By combining investigation and prosecution activities into the proposed special counsel office, designated to handle competition issues, it reduces the ability for investigations to be batted back and forth within USDA.

This legislation also makes many important clarifications to the Packers and Stockyards Act. The Packers and Stockyards Act prohibits unfair, unjustly discriminatory and anti-competitive practices, but some courts have ruled that producers need to prove an impact on competition in the market in order to prevail in such cases involving unfair or deceptive practices. For example, the United States Eleventh Circuit Court of Appeals ruled that a poultry grower operation failed to prove how its case involving an unfair termination of its contract adversely affected competition. The court indicated that the grower had to prove that their unfair treatment affected competition in the relevant market. That is very difficult to prove and was never the intent of the Packers and Stockyards Act.

This legislation also modifies the Packers and Stockyards Act so that poultry growers have the same enforcement protections by USDA as livestock. Currently, it is unlawful for a livestock packer or live poultry dealer to engage in any unfair, unjustly discriminatory or deceptive practice, but USDA does not have the authority to enforce violations because the enforcement section of the law is absent of any reference to poultry. This important statutory change is long overdue. In addition, to better reflect the integrated nature of the poultry industry, this legislation also ensures that protections under the law extend to all poultry growers, such as breeder hen and pullet operations, not just those who raise broilers.

The Agricultural Fair Practices Act of 1967 was passed by Congress to ensure that producers are allowed to join together as an association to strengthen their position in the marketplace without being discriminated against by handlers. Unfortunately, this act was passed with a clause that essentially abolishes the actual intent of the law. The act states that ``nothing in this Act shall prevent handlers and producers from selecting their customers'' and it also states that it does not ``require a handler to deal with an association of producers.'' This clause in effect allows handlers to think of any reason possible to not do business with certain producers, as long as the stated reason is not because they belong to an association.

I propose to expand the Agricultural Fair Practices Act to provide new needed protections for agricultural contracts. As I have mentioned earlier, consolidation in all sectors of agriculture is reducing the number of buyers of commodities and for the very few who are left, many require contracts to conduct business. With so few buyers, it increases the chances that some firms will force unfair contracts upon producers. As a result, some producers have little or no choice but to contract with a firm with questionable practices or face leaving the industry they have known for their whole lives.

This amendment to the Agricultural Fair Practices Act requires that the contract spell out in clear language what is required by the producer. This legislation prohibits confidentiality clauses, ensuring producers the ability to share the contract with family members or a lawyer to help them make an informed decision on whether or not to sign it. This legislation also prevents companies from prematurely terminating contracts without notice when producers have made large capital investments as a condition of signing the contract. And it only allows mandatory arbitration after a dispute arises and both parties agree to it in writing. Producers should not be forced to sign contracts with arbitration clauses thereby preventing them from seeking legal remedy in the courts.

Mr. President, producers deserve to have a fair and evenhanded market in which to conduct business. This legislation won't be able to turn back the clock, but it will strengthen laws and enforcement of them so that markets operate more fairly.

Mr. President, I am honored to join with the distinguished senior Senator from Oregon, Senator Smith, to introduce the Safe Babies Act of 2007.

It is a tragic fact that America's child welfare system is failing our most vulnerable. From birth to age five, children develop their social, emotional, cognitive and moral capacities more rapidly than at any other time in life. Early experiences and relationships are absolutely critical to future development; they set the stage for how well individuals learn, think, control their emotions, and relate to others.

This critical period is a time of tremendous promise, but also a time of great vulnerability. Unfortunately, infants and toddlers are disproportionately affected by child abuse and neglect. Children between birth and age three are twice as likely as older children to become victims of maltreatment, and are three times more likely to be placed in foster care. Abuse and neglect during this significant period can lead to perilous developmental outcomes, including school failure, delinquency and crime, substance abuse, and mental health problems.

Yet the current child welfare system does a particularly poor job of serving infants and toddlers. Once in foster care, infants and toddlers are more likely to be abused. And they stay in foster care longer than older children. More than 40 percent of infants and toddlers involved in a maltreatment investigation are developmentally delayed, yet only 10 percent of these young people currently receive treatment for developmental problems.

A Federal review of 19 States' performance on child welfare outcomes found that all of the States received failing grades on outcomes related to providing adequate physical and mental health services.

Without intervention, we put our future generation at risk and perpetuate the cycle of maltreatment. But we can alter these developmental outcomes by ensuring that children are in safe, permanent homes and have access to necessary mental and physical health care. The Safe Babies Act authorizes funding for juvenile courts to create Court Teams for the integrated handling of infant and toddler abuse and neglect cases. By bringing together the legal, child welfare, and children's services communities, we can promote the health and well- being of our babies and toddlers.

First, this bill establishes a National Court Teams Resource Center. This Resource Center would provide grants and technical assistance to juvenile courts for the creation of local Court Teams to better handle infant and toddler abuse and neglect cases. Few judges have all the necessary knowledge about early childhood development and they frequently lack resources in the community for services necessary for young children. They are often frustrated by the piecemeal provision of services and the overburdened child welfare system. To adequately serve children, they need the expertise of child welfare workers, Guardians Ad Litem, Court Appointed Special Advocates, substance abuse treatment providers and mental health care providers. Court Teams bring together this expertise. Through monthly case reviews, judges can coordinate efforts by all members of the team to ensure efficient and effective provision of services. The goal of these courts is to prevent multiple placements for infants and toddlers in foster care, secure needed services, and find a permanent home for these children as quickly as possible.

Court Teams work with families in an effort to reunite children with their parents. By bringing together multiple service providers, they can facilitate opportunities for parents to learn to create a safe and nurturing home environment. Court Teams ensure support for future reunification only when the

parent is ready and able to step up to provide an appropriate and safe environment. We know from research that each visit between a child and birth parent triples the likelihood of achieving permanence. Through the Court Teams, judges are able to coordinate education and supervision so parents can visit their children and continue to nurture a loving bond.

Although reunification with parents is the ultimate goal, when that is not possible, Court Teams are also focusing on Plan B. By conducting concurrent planning, Court Teams are more likely to find an appropriate placement that will lead to permanency and minimize disruptions. By supporting training for foster parents and newly reunified biological parents, we can prevent children from being bounced around in the foster care system.

Court Teams are also able to coordinate services for children. Judges and child welfare services are able to collaborate to include necessary medical and developmental interventions. By improving access to mental health and substance abuse treatment for parents and children, Court Teams make sure children are able to access needed services and increase the chances of successful, healthy development.

Finally, Court Teams provide services and supports for families to preserve and stabilize homes for children. Judges are able to use court oversight to ensure compliance, facilitate visits with caregivers to promote positive attachments, and make sure that children are in safe environments after placement.

The Safe Babies Act will make an important impact in the way we treat infants and toddlers in the court system. By facilitating involvement from all parties, Court Teams are better equipped to ensure that young children have the community support and services they need. Early evaluation research in the Miami/Dade County court project finds a high rate of permanency for children in the court and increased quality of parent-child interaction. By finding permanent homes, children were able to escape the limbo of the foster care system. More importantly, the court was successful in preventing any future recurrence of abuse or neglect.

Together we can work to protect the safety and well-being of our infants and toddlers. With this legislation, we have the opportunity to ensure that children are placed quickly in safe and loving homes. I look forward to working with my colleagues to ensure that this legislation is passed and signed into law.

Mr. President, as you may have heard, today we are launching the Partnership for Play Every Day and it has been spearheaded by three terrific organizations: the YMCA, the National Recreation and Park Association, and the National Association for Sport and Physical Education. Together, they have 350 years of experience in helping our kids to be physically active or, to use the old-fashioned word, ``to play.''

More than a century ago, these groups came together to support the Playground Movement, which took kids out of factories and coal mines, and gave them parks and playgrounds where they could be children again.

Well, today we face a different challenge. As we confront an epidemic of childhood obesity, as many new elementary schools are built without playgrounds, as recess and PE are phased out of so many of our schools, we need a 21st century Playground Movement. And that's what we are launching this morning.

On a personal note, I have been a lifelong admirer of the YMCA. When I was in my early 20s and aspiring to join the Navy as a fighter pilot, they told me: First you've got to learn how to swim. So what did I do? I signed up at the Y in downtown Des Moines for swimming lessons.

Well, the Y was there for me, just as the Y is there for millions of American families, giving them the facilities and tools to stay fit and healthy.

You know, there is something fundamentally wrong when kids spend their free time parked in front of the TV instead of playing in parks.

I mentioned the childhood obesity epidemic. ``Epidemic'' is not my word. That's what the Centers for Disease Control and Prevention call it. Today, nearly 15 percent of American children and teenagers are obese. A quarter of the children between the ages of 5 and 10 already show the early warning signs of heart disease. Cases of adult-onset diabetes in children--which used to be almost unheard of--have exploded tenfold in the last two decades.

Add it all up, and experts say there is a very real prospect that today's kids could be the first generation in American history to have a shorter lifespan than their parent's generation.

And that is unacceptable. We are not going to let that happen. And that is why we have set the goal of ensuring that every child in America gets 60 minutes of play and physical activity every day.

Hand in hand with this important new initiative, today I am honored to introduce with Senator Hillary Clinton a bill called the PLAY Every Day Act. That first word, PLAY, is an acronym for ``Promoting Lifelong Active Communities.''

The PLAY Every Day Act will help to promote the national physical- activity standards for both children and adults.

To that end, the legislation will do two things:

One, it will mandate the development of a well-validated assessment tool called the ``community play index,'' to identify barriers preventing young people from being physically active in a given community.

And two, it will help local coalitions to use this ``community play index'' as they craft plans to promote physical activity and wellness in their communities.

My vision is to have every community in America focused on promoting

health and preventing disease--instead of just dealing with the bad consequences of obesity, diabetes, and heart disease.

By the way, I am grateful to the good corporate citizens that are joining in the Partnership for Play Every Day, including PepsiCo, Toyota, Kellogg Company, General Mills, PlayCore, and Landscape Structures. Your support of this legislation and new initiative is going to be critical to the Partnership's success.

So, again, I salute all the players in this new Partnership. Together, we can build a better, healthier future for America's children.

Mr. President, I ask unanimous consent the order for the quorum call be rescinded.

Mr. President, I rise to speak today on this FDA bill that has been brought forward by Chairman Kennedy and Senator Enzi. I begin by thanking them for their cooperative, collegial, and inclusive approach over the last couple of weeks to get this bill in a form that makes it much more effective, accomplishing the goals we all have.

Senator Kennedy and Senator Enzi for a long time have been great advocates of making sure we have a strong and effective FDA. Senator Kennedy, of course, has been involved in this for many years and has played a huge role in the success of the FDA, which is, as we know, one of the extraordinarily successful agencies in the Federal Government. It gives the American people confidence, when they go into a grocery store and purchase food or when they go into a pharmacy and purchase a pharmaceutical product or have a prescription filled, that they are going to receive goods which are safe and effective and that they are not going to be at risk of harm as a result of adulteration, fraud, abuse, or misuse of those goods.

It is one of the most amazing successes of our Federal Government in the area of protecting consumers. It arose out of the early 1900 period when there were serious issues relative to food safety in this country, and has evolved into clearly one of the finest agencies, not only in our Government but in the world. It is respected around the world as the gold standard for protecting American citizens and citizens who use the products made by American companies.

This bill builds on that success. I congratulate the Senator from Massachusetts and the Senator from Wyoming for doing such a strong job of building on that success. This bill continues the effort to make sure we have a prompt but safe procedure for getting drugs approved in this country, something called PDUFA, which basically allows drug companies to pay a fairly significant portion of the cost of the approval of new drugs, which has expedited dramatically the rate of approval of new drugs. That means pharmaceuticals and biologics come to the market, which help people, which save lives, which basically makes life better. That is the good news.

In addition, there is, for devices, the MDUFMA proposals, which deal with devices, medical devices the way we deal with pharmaceuticals, setting up a fee system for the approval of medical devices. This is something, when I was chairman of this committee, I had the good fortune to be involved in developing. These two initiatives are the essence of how we maintain a vibrant drug and medical device approval process in this country. It is absolutely critical they be reauthorized, and this bill does it in an effective way.

In addition, the bill takes on a number of other issues which are timely and appropriate. The most significant, from my perspective, although there are a lot of significant ones here, is the issue of drug safety and how we make sure the drugs which do come to the market are safe. This involves not guesswork but finding out what the science is and what happens when people start using these drugs and medical devices. The concept behind that in this bill is that we should set up a regime that basically collects information from all sorts of different sources. There are literally thousands of different sources, but there are some very big ones that we develop information about the reactions people have when they take drugs. We have the tremendous database of the Medicare system, for example. We have the tremendous database of provider groups, such as the Kaiser Permanente fund out in California. These different provider groups have a huge amount of information on what is happening when somebody takes some form of medication. But what happens is that information, although it is collected, is not effectively screened and is not effectively evaluated.

What this bill does, essentially, is create a regime that allows us to more effectively, first, collect the data; second, when there are red flags popping up on that data that say there is a reaction here or reaction there or something occurs here that was not expected, that information becomes more visible under this regime and more available; and then, third, if it is clear there is something that is not going right here, that there is a series of aberrations nobody expected, then it sets up a process where we take that information out and we give it to selected groups of specialists in the academic and private world who have the ability to evaluate that information and tell us what is going on.

There are centers at MIT and I believe at Duke, for example, that do exactly this. The idea, of course, is to first collect the information effectively; second, make sure when those aberrations or red flags start to show up they are noted; and, third, when there is a certain critical mass of information that reflects something that may not be correct or is out of kilter, it makes sure we have that information evaluated in a very science-based, professional way by people who specialize in this and who have the ability to do it--something which FDA does not have the resources, necessarily, to do right now.

With that information in hand, with that science in hand, then you can make decisions. This bill creates a new regime for making those decisions--as to what a company must tell people or tell providers when they are using these different drugs and medications. But it will be a science-based decision, and that is the key here. All of this will key off of science that is hard and that is effectively reviewed and evaluated in order to come to the conclusion that certain actions must be taken in how you distribute this medication and how you communicate what the implications of this medication are. So this new safety and surveillance regime, which is known as mining the information, and then pulling it together and taking advantage of it, validating it and integrating it--this new regime is at the essence of the safety concerns which are involved in this bill.

It is very positive. It opens a new world of review in the area of pharmaceuticals and medicines, a postmarket review process which will be based on science and which will be very healthy to the system as a whole. I congratulate and thank both Senator Kennedy and Senator Enzi for evolving this process in this bill.

In addition, there is the pediatric language in this bill. There is the BSE program, which is the program which basically rewards companies that are willing to go out and do extra research to see how a drug might affect a child. Historically, drugs will be brought to the market and you would never know--because all the clinical exams have been done on adults--how they would affect children. Some of these drugs, obviously, if given to a child, could have a significant negative impact and, if given in the wrong doses, might have an extraordinarily adverse effect. Some could actually be very positive if given in the right dosage. So it became a guessing game as to when these pharmaceuticals, when these medications, were good for children, in many instances. As a result, doctors and prescribers simply didn't know whether to make them available, in many instances, to children.

This BSE pharmaceutical procedure said essentially, We will give you, the producer of this pharmaceutical, of this medication--we will give you an extra 6 months of exclusivity in exchange for your testing this and making sure it will work effectively, or finding out if it will not work effectively, on children. The practical effect of that, of giving that incentive, has been that hundreds of new drugs have been made available to children which were not available before. This has had a very positive impact on children and the ability of children to get pharmaceuticals.

With the BSE program, we also developed a program called the Pediatric Research Equity Act, which essentially takes the opposite approach from the BSE program. It creates a mandate where, in certain instances, certain medications have to be tested on children. They have to go through a process of seeing if they will work for children. The two together basically work in tandem and the idea is they will feed off of each other, and you will create an atmosphere out there where the two different approaches--one basically being a carrot and the other being a stick--will lead to better medications being available for children.

It has worked amazingly well. The key to this, of course, is to keep these two in tandem. In order to accomplish that, they both, in my opinion--and fortunately in the opinion of the chairman and the ranking member of the committee now, at least--have to be on the same wavelength. They have to be dealt with the same way relative to things such as their sunsets, when they get reviewed and when they don't get reviewed, because if you were to have one sunsetted at a different time than the other or one sunset and the other not sunset, you wouldn't get an effective review of the two together, and they both work, as I said, together.

This bill makes sure they are treated the same way in that area, and that is a major step in the right direction toward making sure children get proper pediatric care. There is still going to be an issue tomorrow, I understand, on exclusivity, which is going to be brought up by another Senator; that is, the length of the exclusivity that is necessary in order to get pharmaceutical companies to pursue proper research on children is an issue. But I happen to think what we have now has been shown to work, and why fix something that is not broken, in my opinion. So I believe we should stay with what we have for the 6- month exclusivity period.

In addition, there are a number of other issues floating around this bill. This bill, obviously being a major health care bill, attracts a lot of other concerns. One of them that I have filed as an amendment-- but I don't intend to bring it up unless we move into the issue of reimportation, which may be brought up on the floor--is the question of safety of Internet pharmacies. I believe very strongly, when somebody goes on line and purchases a pharmaceutical product over the Internet-- which is happening more and more often as people become more comfortable with dealing with the Internet on a variety of different levels, but certainly senior citizens as people age into their senior citizenship years who had been dealing with the Internet for quite a few years and are comfortable with it--I believe it is critical we have in place a system which allows people, when they look at the site on the Internet, to know whether that Internet pharmacy is selling the product they say they are selling and whether the product they say they are selling has received FDA approval.

The problem we have here is a lot of these pharmacies will represent that they are selling some sort of pharmaceutical good and it turns out that product is, in many cases, adulterated or inappropriately made, in which case people end up getting a pharmaceutical product which is bad for them. In some cases it can actually lead to death. So it is critical that we have a way so when somebody goes on the Internet and looks at a site on the Internet, they know that Internet pharmacy they are looking at is legitimate and the products they sell are legitimate and have been through the FDA approval process.

In order to accomplish that, we need to set up a whole new regime, basically, and we need to pay for it. This amendment which I have put in accomplishes that. It essentially gives the FDA the authority to review pharmacy sites on line, to meet with the people who have set up those sites, to make sure to set up a certification process where they are guaranteed the sites are meeting the conditions of selling pharmaceutical products or medications which have met the FDA approval, and then to put sort of a Good Housekeeping seal on that site, which is tamperproof, which says this site has FDA-approved products. It would be a huge step forward in safety for American citizens using Internet pharmacies.

It is complicated, though, in its enforcement. It is simple to state but complicated to enforce because it means the FDA needs the resources to deal with these sites and also to deal directly with these pharmaceutical Internet sales places which may be somewhere other than the United States. Second, you have to have in the United States a point at which you can deal with the site if something goes wrong, a responsible representative on the ground in the United States who has the economic wherewithal to basically bond the site, for all intents and purposes.

Setting up that type of regime will be expensive. The language of this amendment puts in place a fee system which allows that to be paid for so we can be assured that the FDA has the resources necessary to review these sites and accomplish this goal of making sure these Internet pharmacy sites are safe for Americans to use. I think this would be a tremendous step forward in safety for all Americans, especially as we move toward a much more

Internet-oriented purchasing process in this country.

Another issue which is going to be discussed here, and which I understand from the chairman may be held over for conference or come into play in some area, is a crucial issue of follow-on biologics or similar biologics.

We know we can produce a generic pharmaceutical and do it with a fair amount of predictability. We know that if a generic company brings on a pharmaceutical product which has run its course, it has proper patent coverage, that that generic is going to be safe and effective and be essentially the same thing as the pharmaceutical because they are chemical compounds.

In the biologics area, this is not the case because you are dealing with a much more complex process of producing the biological medication. It is a fermentation process, it involves proteins, it involves mutation of proteins, which depends to a great extent on a huge number of factors which are very uniquely identified with the way that that vat of medication was evolved through the process.

Anyone who has been to one of these facilities can see how complex it is to maintain consistency, even within the facility that is producing the medication. If you stepped out of that facility and tried to reproduce that medication, the complexities would even be more difficult to replicate.

It is critical that as we move into this biologic area, we understand we are not dealing with generic pharmaceuticals. You know, when you put the title ``generic pharmaceuticals'' on something that is sort of a motherhood term, that is a good idea. It is a good idea if it works. But if you put the generic title on biologics, you are probably going to mislead a lot of people and, in the process, potentially produce medicines which can be extremely harmful or could not accomplish the purposes.

So as we move down this road of looking at biologics and how we give the opportunity to produce similar biologics to people after the patent life has run, we have to be very careful that we don't oversimplify the exercise in the name of getting something, as ``motherhoodish'' as generics; rather, we have to make sure we put in place a process which allows those biologics, when they are produced as similar biologics, to have been properly reviewed to be sure they accomplish what they claim they are going to accomplish.

This means that almost in every instance of an individual biologic, you are going to have to have clinical trials for the similar biologic. There are going to be very rare instances where you can actually bring to the market something that doesn't go through clinical trials in this area, in my opinion, and you have to be very sure that you demonstrate safety and effectiveness of the similar product before you step into this arena of awarding the authority to go ahead and sell that product in the market generally.

You will also need very aggressive postmarket surveillance in this area because you do not know, in many instances--you hope you know, but you do not necessarily know--how individuals will react to taking this type of medication, which is developed as a similar medication, as versus the basic medication which is trying to be replicated.

This area of biologics is a complex one. It should not be rushed into. I know there is a great desire to step forward and say: We have a huge victory for the American people, we can now have generic biologics. But if we rush into this exercise and create a process with approval which does not adequately account for the significantly, the exponentially more complex process of bringing online a biologic when compared to a chemical pharmaceutical, then we will not have done our job as policy people but will simply have given ourselves a good press release and in the end probably have given ourselves a very dangerous process relevant to protecting the American people in the area of biologics.

As we move down this road of generics, I do hope we will move in a way that understands there is a significant difference in pharmaceuticals and that those differences are going to require a much more detailed and a much more complex approval process than we presently have in moving in the generic pharmaceutical area.

Those are some of the concerns I have relative to other issues that might be brought up in this bill. But I do again wish to congratulate the Senator from Wyoming, I wish to congratulate the chairman from Massachusetts for once again bringing to the floor a very strong piece of legislation, which will significantly improve the capacity of the FDA to continue its extraordinary record of protecting the American people relevant to food and drug safety.

I yield the floor.