Floor Statements

Mr. President, I wish to speak today in remembrance of former Senator Robert Stafford, who passed away this past December and for whom we will be having a memorial service this evening.

I personally remember Bob as a moderate voice in the Senate, never putting partisan politics above his principled ideals. He and I served together on the Senate Committee of Labor and Human Resources in the early 1980s, beginning when I was a relatively young first-term Senator chairing the committee and Bob was beginning his third decade of congressional service. I often found Bob's advice and counsel to be helpful in handling many of the issues which came before the committee.

I, personally, remember what a profound influence Bob had on the Labor and Human Resources Committee while I was chairman. As a young chairman and a relatively new Member

of the Senate, I was sometimes frustrated with the way Bob and Senator Lowell Weicker often voted with the Democrats on almost every issue. This disparity of views within my committee forced me to work even harder to forge worthwhile and well-thought-out bipartisan compromises in order to move important legislation. This proved to be an enormous challenge but one that shaped my career and made me a better legislator. There is no question that challenges and beliefs of Bob and Lowell made me the legislator I am today.

Bob was born in 1913 in Rutland, VT. As a product of the Rutland public schools, he attended Middlebury College and received his first degree in 1935. He graduated from Boston University Law School in 1938 and immediately began what would be a long and distinguished career in public service.

Immediately after graduating from law school, Bob served as a Rutland County prosecuting attorney. In 1942, he left the prosecutor's office to serve our country in World War II. Enlisting in the Navy as a lieutenant commander, he served in active duty for the duration of the war.

Bob returned home to Rutland, VT, in 1947 and became a Vermont state's attorney. He served in that capacity for 4 years before volunteering to serve in our Nation's military in another foreign conflict, this time in Korea. Bob once again served honorably in the Navy from 1951 to 1953.

Returning home again in 1953, Robert began his career in Vermont State politics. I think both Senators Leahy and Sanders would agree that Bob was iconic figure in Vermont's political history.

Bob worked in the Vermont Attorney General's Office from 1953 to 1957, serving those last 2 years as Vermont's attorney general. In 1957, he was elected Lieutenant Governor, and in 1959, he was elected to be the State's Governor.

After rising quickly to the top of Vermont state politics, he was elected to Vermont's only seat in the House of Representatives in 1960 and, after being elected to five successive terms, he resigned his seat in 1971 to accept appointment to the Senate, temporarily filling the vacancy left by the death of Senator Winston L. Prouty.

Though he began his Senate tenure as a temporary replacement, Bob would, in many ways, become a permanent part of this institution. He won a special election in 1972 to serve out the remainder of Senator Prouty's term, and he would remain Vermont's Senator for 17 more years, retiring on his own terms in 1989.

As an educated man himself, he was always a champion of higher education. In fact, our Nation's most prominent student loan program was renamed after Bob during his last term in office.

He also played an important role in modernizing Federal disaster relief. In 1988, President Reagan signed into law the Robert T. Stafford Disaster Relief and Emergency Assistance Act, which created the system in place today by which a Presidential disaster declaration of an emergency triggers financial and physical assistance through the Federal Emergency Management Agency, FEMA. Obviously, Bob was instrumental in passing this landmark legislation.

During his time in Congress, Bob and I worked together to reform parts of the Federal entitlement system and to trim the fat from costly Federal programs. Although he and I would often disagree, I always enjoyed hearing his persuasive arguments to articulate his commitment. Even if you didn't agree with Bob's politics, you had to respect the thoughtful and genuine effort he put in to formulating his opinions and arguing his positions. I appreciated Bob very much for his convictions and his passion.

Mr. President, in Bob, our Nation has lost an elder statesman and a principled leader. His leadership and tireless public service are examples for all of us who have aspired to serve this great Nation. I am grateful for this evening's opportunity to remember his service and to reflect on his example.

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

Mr. President, I would like to discuss the amendment which deals with antibiotics and enantiomers, which is included in the managers' package we are adopting today.

I offered this amendment at the HELP Committee markup, but withdrew it with assurances that we would work it out prior to floor action. There have been constructive discussions among all interested parties and I believe we have worked language out that is acceptable.

There is a great urgency to this situation, and I want to make certain my colleagues understand it fully.

The Infectious Diseases Society of America, the Alliance for Aging Research, the Institute of Medicine, the Resources for the Future, the Centers for Disease Control, and many others have been sounding the alarm about the growing threat from resistant microorganisms and the need for innovation in the area of antibiotics.

Congress must listen.

Nobel Laureate Joshua Lederberg said it well:

We are running out of bullets for dealing with a number of

(bacterial) infections. Patients are dying because we no

longer in many cases have antibiotics that work.

The Hatch amendment is intended to be an initial step in the fight against these resistant strains of bacteria by increasing incentives and innovation.

Additionally, the language in the amendment requests FDA to work with companies to apply the Orphan Drug Act to antibiotics wherever possible. Hand-in-hand with this, it reauthorizes the Orphan Drug Act grant and contracts from fiscal years 2008 through 2012. As many of my colleagues know, this act has resulted in important medicines for rare diseases.

The Hatch amendment also ensures that currently existing incentives for new drugs are available for new single enantiomers in new therapeutic areas such as Alzheimer's, cancer, and type II diabetes among others. In 1997, FDA issued a Federal Register notice acknowledging that the policy needed clarification and this amendment would do that.

Let me start with the issue of antibiotics and the need for new antibiotics to fight drug-resistant infections. Many of us have become more and more concerned that there is an alarming increase in the number of drug-resistant infections--many of them serious--and we are running out of treatment options.

My first chart is based on data from the Centers for Disease Control and

Prevention and shows how resistant strains of infections have spread rapidly from 1980 to 2000. My colleagues, this is a very alarming trend and sadly, for all of us, the problem of resistance continues to grow.

A report many of us are familiar with, Bad Bugs, No Drugs, from the Infectious Diseases Society of America, IDSA, highlights the lack of R&D for new antibiotics.

Antibiotics are not profitable compared to medications that treat chronic conditions and lifestyle issues. Also, antibiotics are taken for short periods of time--unlike medications for chronic disease which may be taken daily.

And, when a new antibiotic comes on the market, it is discouraged from use to avoid the development of resistance. As a result, it is fair to say that major pharmaceutical companies have not been making significant investments in antibiotics.

Given that there are few, if any, antibiotics in the drug development pipeline, if Congress fails to act, we walk blindly into a future where we must fear basic infections we have long taken for granted are not a problem.

Medicine changed dramatically when penicillin was discovered and physicians had a tool to treat deadly infections.

Can any of my colleagues imagine life without penicillin? I am sorry to inform you, we are about there.

Over the years, many infections became resistant to penicillin, but we were OK--we moved on to the next antibiotic. We had methicillin--and now serious infections are resistant to that.

We should consider what the health professionals are telling us. Will we listen? We are taking antibiotics and our ability to treat bacterial infections for granted.

Infectious disease doctors from all over the country have been writing to their Senators to express their support for my amendment. They tell heart-wrenching stories.

Dr. Helen Boucher, a physician at Tufts Medical Center in Boston, MA, wrote to tell Congress that patients are routinely lost ``to infections caused by resistant bacteria for which we have few to no options. [They] recently lost two bone marrow transplant recipients who survived all the chemo but died of multiply-resistant gram negative infections. In both cases, [physicians] pulled an old antibiotic off the shelf and gave it as a last resort, knowing how toxic it was but having NO other options for these young people. . . .''

She wrote:

As a doc and an American, it's horrifying to know that few

to no companies are investing even in discovery of new

antibiotics for these infections . . . just this week [she]

was presented a case of a previously completely healthy 33

year-old lady who presented to the hospital in Boston with

pneumonia and died within 6 hours from community-acquired

MRSA. Her story and so many others that we see ALL the time,

make the need for new and powerful options to treat these

infections critical.

Community-acquired MRSA is an infection that was historically acquired while in the hospital, but now is impacting young, healthy people. We have heard stories of high school, college and professional athletes losing their lives or careers as a result of these infections. Sadly, this infection has become far too common, difficult to treat and has few options to fight it. It can leave individuals disfigured, if they survive.

In my own State of Utah, the number of children with MRSA infections at the Primary Children's Medical Center in Salt Lake City has dramatically increased since 1989.

Dr. Andy Pavia of Salt Lake City told me that he ``cared for a 2 month old girl who developed MRSA pneumonia and almost died as a complication of an otherwise mild respiratory infection. She survived and will be going home to her parents, but only after 2 weeks of the most sophisticated intensive care and an additional 4 weeks of intravenous antibiotics.''

Dr. Pavia went on to explain that the Primary Children's Medical Center sees the impact of resistant bacteria almost every day.

In fact, he wrote:

Last week a two year old girl [who] was weeks away from

being cured of Burkitt's lymphoma developed shock due to a

bloodstream infection with a highly resistant strain of a

gram-negative bacteria. Fortunately, the bacteria was

sensitive to one remaining antibiotic. If it had been

resistant, she would not have left the Pediatric ICU alive.

The doctor related that MRSA is an aggressive, difficult to treat, form of staph that has spread rapidly within communities. Half of the children he sees with severe MRSA infections acquired their infection at home.

This is a picture of Bryce, whose family tells a similar story. He had his first cold 2 days before Christmas. Before then, 14-month-old Bryce Smith had never been sick. At 2 a.m. on New Year's Day, his parents took him to the emergency room, where the seriousness of their son's condition became immediately apparent.

An X-ray showed that Bryce had pneumonia. A CT scan showed that his right lung was filled with fluid. Four hours after arriving at the ER, Bryce was scheduled for surgery. Doctors found that a methicillin- resistant staph infection had eaten a hole through his lung.

For the first 12 days that Bryce was in the hospital, the doctors didn't know whether he would live. Doctors battled to force air into the child's lungs, but as they told his mom, it was like trying to pump air into a brick.

Doctors prescribed high levels of antibiotics, including vancomycin, in a desperate battle to fight the infections. For 6 weeks, the child did not wake up. During Bryce's stay in the hospital, he has suffered from several additional infections. Bryce is doing much better now, he was released from the hospital, but he still must relearn how to walk. His recovery could take several months. As of April 2007, the Smiths' total bill for Bryce's care is just under $1 million.

Fortunately, the family's insurance does not have a ceiling on payments; otherwise, the Smiths say they would be in financial ruin. Bryce's ongoing care needs are decreasing, but he still has regular visits with the pulmonologist, nephrologist, and his pediatrician. He still tires out easily with exertion.

The fact that children acquire this infection at home is significant because we used to only worry about it in the hospital.

Last month, there were numerous articles about CDC's concern that cases of resistant gonorrhea have dramatically increased and respond to only one antibiotic.

There has been much concern over the past couple months related to extensively-drug resistant--XDR-TB. Right now, there is a man in Phoenix, AZ, whom authorities took action to isolate in order to avoid the spread of the deadly XDR-TB infection he had contracted while out of the country.

This comes in addition to the numerous reports of our soldiers coming home from Iraq with Acinetobactor--a resistant infection that is especially difficult to treat and the only option is a very toxic antibiotic.

One doctor we have heard from, in a local community, indicated he has seen two patients just this month with infections resistant to every antibiotic currently available.

That is becoming a common occurrence.

Infections disease specialists can do little more than provide supportive care for those unfortunate patients. Without any new antibiotics in the pharmaceutical pipeline, there is no promise of a treatment for years to come.

Whatever we do to begin to address this serious concern, we can't hope to realize the benefit for more than a decade. Drug development takes time and money. Yet few companies are willing to invest either in the area of antibiotics.

I believe this chart shows that is the case. As you can see from this chart, the number of new antibacterial agents that have actually been approved is minimal. The market forces don't work well for antibiotics. When we cannot rely on the market, government has an obligation to step in.

The Hatch amendment focuses on incentives for research and development of antibiotics. Specifically, my amendment: Provides equitable treatment for so-called ``old'' antibiotics; promotes communication and education of current law orphan drug incentives by directing FDA to convene a public meeting to clarify what ``bad bugs'' may qualify for orphan designation; reauthorizes the Orphan Drug grants and contracts program which expired September 30, and requires FDA to establish, update and make publicly available information on antibiotic

breakpoints. This is important to assure that the antibiotics we and our children take are effective against bacterial infections and minimize the progression of resistance.

Antimicrobial resistance is a public health crisis. In many ways, it is even bigger than drug safety, a point our colleague, Dr. Coburn, made at the HELP mark up.

This is an issue that touches not just the old or the young, but all Americans throughout every walk of life. Antibiotics are as precious a natural resource as water is to a vibrant and healthy community and, guess what, the creek is drying up. The Hatch amendment only takes the first steps to address these issues.

If we cannot work together on these more minor provisions, how will we truly combat antimicrobial resistance? What will we say to the children, soldiers, athletes, elderly and so many others that contract these deadly diseases which only years before were successfully treated with antibiotics? Are we really willing to walk away and leave nothing in our arsenal to fight these bad bugs?

I would like to turn my attention now to a provision in the Hatch amendment which encourages innovation in another area. This provision provides for 5-year exclusivity for enantiomers of previously approved racemic drugs in different therapeutic areas based on new data.

Enantiomers are mirror images of the same drug. You can think of them as left-handed and right-handed molecules. We now understand that, in some cases, these enantiomers have very different activity and safety profiles.

In simplest terms, imagine the biological target is a glove that fits one hand better than the other. When Hatch-Waxman was passed originally, we didn't contemplate the isolation of one enantiomer from an approved drug made up of a mixture of enantiomers and its development for a new use based on all new data.

But today that is exactly what is happening. Sponsors are finding new important uses for enantiomers of drugs previously approved as a mixture of enantiomers.

Where FDA is requiring all new data for approval of these single enantiomers and will not allow a company to rely on any of the data submitted in the original application for the mixture of enantiomers, these single enantiomers are effectively new chemical entities and should be entitled to 5-year exclusivity.

In 1997, in a Federal Register notice, FDA laid out the issue, acknowledging the lack of clarity in the law regarding 5-year exclusivity for enantiomers and the need to incentivize this type of development. FDA requested comments but never finalized a policy.

The Hatch amendment makes it clear that development of an enantiomer for new use in a new therapeutic area based on new data would qualify for 5-year exclusivity. However, in order to address the potential for abuse the revised provision limits 5-year exclusivity to approvals in a new therapeutic class.

As this chart states, innovation and development of enantiomers may provide treatments in cancer, Alzheimer's disease, type II diabetes. When it comes to FDA, we need to get it right.

I feel we have done a lot of good with this bill, and I voted for it in committee with the understanding the issues I raised on antibiotics and enantiomers would be addressed before we reached final passage. I am glad that, as of yesterday afternoon, we have worked out all remaining concerns and I believe the chairman's commitment at the markup has been honored.

I know that some were concerned about this amendment, specifically because its incentives provisions were fueled by exclusivity. With all due respect, I understand the importance of the generic drug industry. We spoke earlier about the need to get it right for follow-on biologics.

But we should listen to the public health associations, who understand the need to support innovation. Indeed, the Alliance for Aging Research, Infectious Diseases Society of America, National Organization of Rare Disorders, and Immune Deficiency Foundation are dedicated to advocating for patients and doctors and improving public health in this country, and they fully support this amendment in its entirety.

The Infectious Diseases Society of America represents doctors that see the threat of resistant bugs every day. They recognize the need for innovation in their therapeutic area.

This isn't different than 10 years ago when the American Academy of Pediatrics argued passionately for the need for innovation in pediatric research. Some may not remember that the generic drug industry opposed that provision saying that innovation was not necessary.

In contrast, I am pleased that we have achieved an agreement today that recognizes the need for this innovation in research involving antibiotics and enantiomers.

Ten years ago, Congress passed the last major piece of FDA legislation, the Food and Drug Administration Modernization Act, or

I rise to speak about the amendment I offered to S. 1082 on antibiotics access and innovation. My amendment is supported by the Infectious Diseases Society of America, IDSA, the Alliance for Aging Research, the National Organization of Rare Disorders, and the Immune Deficiency Foundation. It is intended to take initial steps to address the important issue of drug resistant microorganisms and the need for new antibiotics. Senate Health, Education, Labor, and Pensions Committee Chairman Ted Kennedy and its Ranking Member Mike Enzi have worked with me on the provision as well as Senators Burr, Brown, and Cochran. I appreciate all their efforts to address this important issue and am pleased that we have reached an agreement on language to include in S. 1082.

Senator Kennedy has always been a leader in public health issues and I appreciate the efforts of him and his staff to address this important matter. However, I am concerned one provision of my amendment that was not included which deals with bioequivalence standards for locally-acting non-absorbed drugs. In the amendment I filed for Committee, I had asked for the Food and Drug Administration to establish a new bioequivalence standard for these drugs through a guidance allowing for transparency and a public process. The underlying bill deals with drug safety and although I am a supporter of the generic drug industry, I want to ensure that their bioequivalence standards are based on science--we need to ensure that FDA is applying high scientific standards and allowing for public input when these standards are developed by the Office of Generic Drugs.

Yes, it is. I appreciate the remarks of the Senator from Ohio. I yield to the Senator from Mississippi.

I thank the Senator from Mississippi for his leadership on this matter. I agree that we need to pursue this further if we don't get good answers from the FDA. The agency's lack of a response is a big concern to me.

I might also add that your health advisor, Leigh Ann Ross, who is a pharmacist, has been very helpful in explaining the issues of pharmaceutical science at issue here. I also want to acknowledge the work of my colleague from Massachusetts who has shown great leadership here and his dedicated staffer, David Dorsey, who has worked tirelessly on this entire bill and this issue in particular. I also appreciate the hard work of Senator Enzi's staff person, David Schmickel, who has made great efforts to reach an agreement on this issue. We would not have been able to reach this point without Senator Kennedy's and Senator Enzi's leadership on the entire bill.

In addition, I would like to acknowledge Senator Brown's health staffer, Ellie Dehoney, who has made valuable contributions to this discussion.

I thank the Senator. I appreciate my colleagues' willingness to work with me on this important issue. Although the language on the bioequivalence issue is not in the agreed-to version of the amendment, by accepting the revised amendment, I want to make it perfectly clear that we want to have clear answers from the FDA on its current process in establishing a bioequivalence standard for

locally-acting non-absorbed drugs. It is certainly not my intent or the intent of my colleagues to suggest that we have concluded the oversight of FDA on this issue. Instead, we have agreed to engage with FDA through the oversight function of the HELP Committee to ensure that the scientific standards and procedures used in establishing bioequivalence for this life-threatening antibiotic are appropriate.

I thank the Senator from Pennsylvania and I know that he has been in communication with FDA regarding this issue. His contributions to this dialog have been considerable. I look forward to working with him, Senator Cochran and my HELP Committee colleagues in getting some answers from the FDA on this situation.

Authorized Generics

My friend from West Virginia has had a longstanding interest in looking into this issue, and I certainly don't fault his tenacity in this area. When Congressman Henry Waxman and I wrote the Drug Price Competition and Patent Term Restoration Act in 1984, our intent was to improve generic competition, while preserving the ability of brand-name manufacturers to discover and market new and innovative products. I think this legislation has worked fairly well at achieving its intended goals. I know there have been a few problems along the way, but I think we addressed many of them in the Medicare Modernization Act of 2003. In that law, Congress closed several loopholes that were delaying generic competition and hindering consumer access to lower cost generic drugs. The law also clarified the 180-day period of market exclusivity for generic manufacturers. Now, I know Senator Rockefeller is very concerned about authorized generics, and I think we should have updated data on the number of authorized generic drugs are on the market. The language already included in S. 1082 will help the Federal Trade Commission complete its authorized generics study, which I know Senator Rockefeller requested along with Senators Grassley and Leahy. I support the completion of that study; however, Congress shouldn't contemplate additional legislation before having necessary data on authorized generics. I will work with my good friend and colleague from West Virginia to ensure that the FTC has the data needed to complete its study. So, I want to let my friend from West Virginia know that I want to continue to have a dialogue about this issue.

Mr. President, a number of questions have been raised about how the Durbin amendment on food safety, adopted yesterday by a unanimous vote, would affect regulation of dietary supplements.

I wanted to take this opportunity to clarify the record.

First, let me indicate my support for the efforts of the Senator from Illinois, Mr. Durbin. The recent misfortunes

with peanut butter, spinach, and pet food show me that our Nation's food safety policies are pitifully lacking. Therefore, I am supportive of Senator Durbin's work and also the considerable work of Senator Enzi and his staff to resolve problems that were found with the draft amendment.

For the edification of my colleagues, section 201ff of the Federal Food, Drug and Cosmetic Act, FFDCA, contains the definition of dietary supplements. That definition includes a proviso that supplements are to be considered foods, except in the instance when a product makes a drug claim. In other words, by Federal law, dietary supplements are generally considered to be foods.

It is for this reason that the language of the original Durbin amendment establishing a new adulterated food registry could have been read to apply to dietary supplements.

This raised problems for me, and indeed for our colleague Senator Harkin, since we had spent more than 2 years working with Senators Durbin, Kennedy, and Enzi to draft, pass and enact the Dietary Supplement and Nonprescription Drug Consumer Protection Act, Public Law 109-462. That law authorizes a new program so that reports of serious adverse events related to the use of a dietary supplement or over-the- counter drug would be reported to the Food and Drug Administration, FDA, on a priority basis.

As I said, the Durbin amendment contemplates a new adulterated food registry. Under the provisions establishing that registry, reports of adulterated foods would be made by many, if not all, of the same parties who are required to file reports of serious adverse events associated with the use of dietary supplements under Public Law 109- 462. And so passage of the Durbin amendment could be seen to supersede the law we enacted last year for supplements, which I am relieved to hear was not the intent of our colleague, Senator Durbin.

Consequently, the amendment we adopted yesterday contains language that Senator Harkin and I suggested to make certain that dietary supplements would not be covered by the new food safety language and thus last year's law would not be superseded. To reassure those who are interested in the Dietary Supplement Health and Education Act, DSHEA, I wanted to take a moment to outline those changes.

First, there is new language in the section establishing the adulterated food registry to express the sense of the Senate that: (1) DSHEA has established the legal framework to ensure that dietary supplements are safe and properly labeled foods; (2) the Dietary Supplement and Nonprescription Drug Consumer Protection Act has established a mandatory reporting system of serious adverse events for nonprescription drugs and dietary supplements sold and consumed in the United States; and (3) the adverse events reporting system under that act will serve as the early warning system for any potential public health issues associated with the use of these food products.

In addition, language contained in the Durbin amendment modifies the definition of supplement contained in 201ff of the FFDCA so that supplements will not be considered foods for the purpose of the new adulterated foods registry. This in no way would alter the time-honored conclusion of the Congress that supplements are to be considered foods. On the contrary, all it would do is exempt supplements from the registry.

These changes, all contained in the amendment which was approved yesterday, make clear that there are no new dietary supplement requirements in the Food and Drug Administration Revitalization Act. It is my hope this will reassure the many who have expressed concern that Congress was inadvertently repealing Public Law 109-462.

Mr. President, I thank my dear colleague from Tennessee for allowing me to go first, and also my two colleagues on the Democratic side, Senators Carper and Stabenow.

I ask unanimous consent that Senator Alexander be permitted to go next and then Senator Carper and then Senator Stabenow.

I think we have an agreement among the four of us.

I would add to that request the Senator from Oklahoma after Senator Stabenow.

Mr. President, I thank my colleagues, including the two managers of the bill on both the Democratic and the Republican side.

I rise in support of the Allard amendment. I want to take a few minutes to talk about pediatric testing and research provisions included in this bill. I have strongly supported both the Best Pharmaceuticals for Children Act and the Pediatric Research Improvement Act.

As my colleagues know, current law provides 6 months of exclusivity for drugs that do research and development in the area of pediatric use. I am very interested in keeping it that way. That has proven very efficacious in the Hatch-Waxman bill. It keeps companies involved in developing great drugs for children in this area. So it is a very important part of this.

I was deeply involved in those negotiations in 1997 with my former colleague, our former colleague, Senator Mike DeWine. I have supported these efforts from Ohio Senator Mike DeWine that brought 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. As a result, pediatric drugs are safer and more effective for children. The bill before us today reduces the 6-month exclusivity period for blockbuster drugs to 3 months.

I emphasize again this market exclusivity has provided the incentive needed to increase research and development for pediatric drugs. We used the

same type of an approach on the orphan drug bill many years ago. At that time there were only a few orphan drugs. Today there are over 300 being developed. It is the same principle here.

The Allard amendment restores current law and provides 6 months of exclusivity for all drugs. As I mentioned last night, my good friend and colleague from Connecticut, Senator 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, who has served long and well on this committee.

That hearing was very insightful, and I believe 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.

By giving companies market exclusivity to conduct clinical trials, we will know the safest dosage levels for children. So let's not lose sight of the original purpose of these programs: to help children have the safest dosages for prescriptions.

Now, it is no secret I support the Allard amendment. I would just like to add a few more facts. Nearly two-thirds of the drugs prescribed for children have not been studied and labeled for pediatric use. I know the importance of accurate clinical information about a drug's use in the pediatric population. This smaller body mass and higher metabolic rates of children mean they often respond differently to drug dosing than adults do.

A drug that is safe and effective in adults may not always be safe for children. The question is not whether we should study the safety of drugs for children but how we make that research happen.

In 1997, Congress considered this issue and created an incentives program for companies to study the use of their drugs in pediatric populations. The program offers an additional 6-month patent protection or exclusivity to drug manufacturers to help recoup the cost of investing in these critical pediatric studies. It is a win-win situation. Drug companies have the incentive to invest time and extra resources for a small share of the market, and, more importantly, children get the research they need.

The evidence is that the incentives for exclusivity should be maintained, not lowered. Despite the fact that the bill providing the incentive for pediatric studies was enacted a decade ago, nearly two- thirds of the drugs prescribed for children have not been studied and labeled for pediatric use.

We have had a great deal of study about the need for this incentive and how it should work.

The fact remains that there is a persistent public health need for accurate clinical information about how adult drugs will work in children.

Children are not adults, for reasons that the Senator from Oklahoma, Dr. Coburn, has well explained to this body.

Much of what our colleague from Connecticut, Senator Dodd, has just said underscores the need for a continued, strong, exclusivity provision.

The statistics he cited about the success of this program are truly remarkable and a significant milestone in the history of public health.

The only place where there seems to be disagreement on Best Pharmaceuticals for Children Act is the exclusivity period for what some define as ``blockbuster drugs.'' I know the Senator may call the 6 months period ``gouging'' but that ``gouging'' may very well be the incentive that has led to the FDA receiving more than 400 proposed pediatric-study requests and receiving 144 completed studies.

Those who support the Senator's amendment--and I know it is well- intentioned--suggest that without the 6 months' incentive, the pediatric testing will still continue and will be robust. Who knows if this is true?

I wonder if we want to call their bluff and take away this powerful incentive? I don't think we can take that chance.

I am happy to discuss this issue with my colleagues. As they are aware, this has been my high priority for a number of years, given that I am the author with Representative Henry Waxman of the Drug Price Competition and Patent Term Restoration Act--or ``Hatch-Waxman''. The Schumer-Clinton bill, which I know has been introduced by Representative Waxman in the House, is an important contribution to this dialogue. I want to work to reach an acceptable compromise on an expedited basis, and it is clear to me it must be a bipartisan effort.

I look forward to working with my colleagues to include bipartisan follow-on biologics legislation in the conference agreement on the FDA Revitalization Act. It is clear that consumers would benefit tremendously from an abbreviated pathway for consideration of biosimilar products. Any effort, though, must be based on a sound understanding of the science involved and it must contain incentives for development of the innovator products which will be copied.

Will the Senator yield?

Mr. President, I thank my dear friend and colleague. It is so nice of him to say that. I take tremendous interest in this bill, as I do every piece of legislation, but this bill in particular.

I congratulate the chairman and the ranking member for the way they have conducted not only the committee through this process but this bill itself. I hope this bill will pass and that we can correct whatever needs to be corrected, and that we will be able to do this follow-on biological work together. If we can do that, this will be a major breakthrough bill, and will do a great deal of good for the FDA. If that happens, then I think the chairman and the ranking member deserve a great deal of credit. I am very grateful my friend from Massachusetts has been so kind to me today.

Mr. President, to say the distinguished Senator from New York knows how to stick it to a person on the floor is all I can say.

I am grateful for this friendship and grateful for his and Senator Clinton's work on this as well, and willingness to work together in a bipartisan way. This is big-time stuff. If we get it right, it will surely do a lot of good, as Hatch-Waxman has done over the last 23 years.

My office has been inundated by calls from people throughout the country who believe that this legislation, specifically the provision establishing a Reagan-Udall Institute, will overturn the Dietary Supplement Health and Education Act of 1994. That has not been my reading of the bill, but I wonder if other Senators have heard similar concerns?

That explanation is very helpful. What, specifically, would the role of the Foundation be with respect to dietary supplements?

To add to that point, it seems that the language could, in fact, help dietary supplement consumers, because it would allow collaboration between government and industry to conduct research on issues that might be helpful to supplement consumers?

I thank you for those assurances and that clarification.

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.

Mr. President, I rise today to join with Senate Committee on Homeland Security and Governmental Affairs Chairman Joseph Lieberman and Senator Robert Bennett in introducing the District of Columbia Voting House Rights Act of 2007. Our colleagues in the House of Representatives recently passed similar legislation, H.R. 1905, that would provide a fourth congressional seat for my home state of Utah and the first voting member for the District of Columbia. No doubt, this is a historic time for the citizens of the District of Columbia and a unique opportunity for Utah to receive a long overdue fourth congressional seat.

The Founding Fathers made clear in article 1, section 8 of the Constitution that the District of Columbia would be the seat of the national government and granted Congress the power ``[t]o exercise exclusive Legislation, in all Cases whatsoever, over such District (not exceeding ten Miles square) as may, by Cession of particular States, and the Acceptance of Congress become the Seat of the Government of the United States . . .'' This clause became effective in 1790 when Congress accepted land that Maryland and Virginia ceded to the United States to create the national capital. Ten years later, in December 1800, jurisdiction over the District of Columbia was vested in the Federal Government. Since then, District residents have not had the right to vote for Members of Congress. Additionally, article 1, section 2 and section 3 of the Constitution provides that citizens of States shall have voting representation in the House and Senate.

During my time in the Senate, I have heard from many District residents who believe strongly that their voice should be heard in Congress. They pay taxes, vote in presidential elections, and serve in the military. Yet these nearly 600,000 Americans do not have a voting representative in Congress. Many, including myself, have been reluctant to support previous proposals based upon the constitutional principle that States, not territories, are afforded congressional representation. I understand the argument that congressional representation is dependent on statehood and, therefore, the Constitution would need to be amended before the District is given a voting representative in Congress. While the Constitution does not affirmatively grant District residents the right to vote in congressional elections, it does affirmatively grant Congress plenary power to govern the District's affairs. Indeed, the Constitution grants Congress exclusive authority to legislate all matters concerning the District, and I believe this authority extends to the granting of congressional voting rights for District residents.

I support this legislation not only because it rectifies the District's undemocratic political status, but it gives my home State of Utah a long overdue fourth voting Member in the House of Representatives.

During the 2000 Census count, Utah missed out on a fourth House seat by only 857 people. The Census Bureau counted members of the military serving abroad as residents of their home State, but did not count an estimated 14,000 Utah missionaries from the Church of Jesus Christ of Latter-day Saints living abroad. Utah took its fight for a fourth seat all the way to the Supreme Court, but lost. Instead, North Carolina gained another seat in the House by 856 residents. Since then, I have heard from many Utahns and share their frustrations about the outcome of the 2000 Census.

Why push for an additional seat now? Under normal circumstances, Utah would have to wait until the 2010 Census to see if its growing population justifies another congressional seat. However, the proposed legislation provides Utah a chance to receive another voting member of Congress 5 years early. That is equivalent to two and a half terms for a Member of Congress and places the new Member well on his or her way in establishing seniority and influence for the benefit of Utah's citizens. I don't think this is an offer we should dismiss.

I have some constitutional concerns with H.R. 1905's attempt to impose an at-large seat upon my State of Utah. In States with more than one seat in the House, Members are expected to represent insular constituencies. Under H.R. 1905, residents of one State would be represented by two House Members while citizens in other States would have one. In addition, in our constitutional system, States are responsible for elections and Utah has chosen the approach it wants to take by redistricting. I see no warrant for Congress to undermine this balance and impose upon Utah a scheme it has not chosen for itself. For this reason, in the proposed Senate legislation, I insisted that Utah be required to redistrict to provide for the new seat. I believe that Utah's legislators deserve the freedom to determine their representatives' districts without unjustified intrusion or mandate of the Federal Government.

Additionally, the House bill would require Utah to hold a special election in 2007 if the bill passes. The Senate version requires that both seats be elected in the November 2008 general election. Thereafter, both new Members would begin their service at the start of the 111th Congress in 2009.

In conclusion, let me say that I recognize there are many who strongly oppose this legislation. There are many who wish the District voting rights issue would simply go away. The Democratic-controlled Congress could have simply pushed forward with legislation giving the District of Columbia a seat without balancing a ``Democrat'' seat with a ``Republican'' seat. I am pleased that this was not the case. The House of Representatives has already voted in favor of moving this legislation forward. Now it is up to the Senate. Let me be clear, the proposed legislation does not provide Senate representation for the District of Columbia. I am not in favor of granting two Senators for the District and would not support such a proposal.

As one who represents Utah, I have an important responsibility to ensure

that my State is dealt with properly and fairly. And, in light of the House's recent legislative action, I am determined to do all that I can to ensure that Utah's fourth seat configuration is done right. I want my fellow Utahns to know that the window of opportunity is quickly closing. In fact, I dare say there won't be another opportunity like this again. For this reason, I intend to make the most of it and hope that my Senate colleagues will support me in this endeavor.

Mr. President, I rise today to join with Senate Committee on Homeland Security and Governmental Affairs Chairman Joseph Lieberman and Senator Robert Bennett in introducing the District of Columbia Voting House Rights Act of 2007. Our colleagues in the House of Representatives recently passed similar legislation, H.R. 1905, that would provide a fourth congressional seat for my home state of Utah and the first voting member for the District of Columbia. No doubt, this is a historic time for the citizens of the District of Columbia and a unique opportunity for Utah to receive a long overdue fourth congressional seat.

The Founding Fathers made clear in article 1, section 8 of the Constitution that the District of Columbia would be the seat of the national government and granted Congress the power ``[t]o exercise exclusive Legislation, in all Cases whatsoever, over such District (not exceeding ten Miles square) as may, by Cession of particular States, and the Acceptance of Congress become the Seat of the Government of the United States . . .'' This clause became effective in 1790 when Congress accepted land that Maryland and Virginia ceded to the United States to create the national capital. Ten years later, in December 1800, jurisdiction over the District of Columbia was vested in the Federal Government. Since then, District residents have not had the right to vote for Members of Congress. Additionally, article 1, section 2 and section 3 of the Constitution provides that citizens of States shall have voting representation in the House and Senate.

During my time in the Senate, I have heard from many District residents who believe strongly that their voice should be heard in Congress. They pay taxes, vote in presidential elections, and serve in the military. Yet these nearly 600,000 Americans do not have a voting representative in Congress. Many, including myself, have been reluctant to support previous proposals based upon the constitutional principle that States, not territories, are afforded congressional representation. I understand the argument that congressional representation is dependent on statehood and, therefore, the Constitution would need to be amended before the District is given a voting representative in Congress. While the Constitution does not affirmatively grant District residents the right to vote in congressional elections, it does affirmatively grant Congress plenary power to govern the District's affairs. Indeed, the Constitution grants Congress exclusive authority to legislate all matters concerning the District, and I believe this authority extends to the granting of congressional voting rights for District residents.

I support this legislation not only because it rectifies the District's undemocratic political status, but it gives my home State of Utah a long overdue fourth voting Member in the House of Representatives.

During the 2000 Census count, Utah missed out on a fourth House seat by only 857 people. The Census Bureau counted members of the military serving abroad as residents of their home State, but did not count an estimated 14,000 Utah missionaries from the Church of Jesus Christ of Latter-day Saints living abroad. Utah took its fight for a fourth seat all the way to the Supreme Court, but lost. Instead, North Carolina gained another seat in the House by 856 residents. Since then, I have heard from many Utahns and share their frustrations about the outcome of the 2000 Census.

Why push for an additional seat now? Under normal circumstances, Utah would have to wait until the 2010 Census to see if its growing population justifies another congressional seat. However, the proposed legislation provides Utah a chance to receive another voting member of Congress 5 years early. That is equivalent to two and a half terms for a Member of Congress and places the new Member well on his or her way in establishing seniority and influence for the benefit of Utah's citizens. I don't think this is an offer we should dismiss.

I have some constitutional concerns with H.R. 1905's attempt to impose an at-large seat upon my State of Utah. In States with more than one seat in the House, Members are expected to represent insular constituencies. Under H.R. 1905, residents of one State would be represented by two House Members while citizens in other States would have one. In addition, in our constitutional system, States are responsible for elections and Utah has chosen the approach it wants to take by redistricting. I see no warrant for Congress to undermine this balance and impose upon Utah a scheme it has not chosen for itself. For this reason, in the proposed Senate legislation, I insisted that Utah be required to redistrict to provide for the new seat. I believe that Utah's legislators deserve the freedom to determine their representatives' districts without unjustified intrusion or mandate of the Federal Government.

Additionally, the House bill would require Utah to hold a special election in 2007 if the bill passes. The Senate version requires that both seats be elected in the November 2008 general election. Thereafter, both new Members would begin their service at the start of the 111th Congress in 2009.

In conclusion, let me say that I recognize there are many who strongly oppose this legislation. There are many who wish the District voting rights issue would simply go away. The Democratic-controlled Congress could have simply pushed forward with legislation giving the District of Columbia a seat without balancing a ``Democrat'' seat with a ``Republican'' seat. I am pleased that this was not the case. The House of Representatives has already voted in favor of moving this legislation forward. Now it is up to the Senate. Let me be clear, the proposed legislation does not provide Senate representation for the District of Columbia. I am not in favor of granting two Senators for the District and would not support such a proposal.

As one who represents Utah, I have an important responsibility to ensure

that my State is dealt with properly and fairly. And, in light of the House's recent legislative action, I am determined to do all that I can to ensure that Utah's fourth seat configuration is done right. I want my fellow Utahns to know that the window of opportunity is quickly closing. In fact, I dare say there won't be another opportunity like this again. For this reason, I intend to make the most of it and hope that my Senate colleagues will support me in this endeavor.

Mr. President, I ask unanimous consent that Remy Yucel, a fellow in my staff, be granted the privilege of the floor for the pendency of the consideration of S. 1082, including any conference report.

Mr. President, I wish to honor my good friend Jack Valenti, who, passed away last week on April 26.

Throughout his life, Jack Valenti wore several hats, including that of a soldier, a devoted public servant, and a pioneer in the film industry.

Jack was born on September 5, 1921, in Houston, TX and was the grandson of Sicilian immigrants. At age 15, he became the youngest high school graduate in the history of the city of Houston and began a career as an office boy with Exxon Oil.

Jack served honorably in the Army Air Corps during World War II, flying in 51 separate combat missions as pilot of the B-25 attack bomber with the 12th Air Force in Italy. He obtained the rank of lieutenant and received multiple decorations, including the Distinguished Flying Cross, the Air Medal with four clusters, the Distinguished Unit Citation with one cluster, and the European Theater Ribbon with four battle stars.

After serving in the war, Jack attended college at the University of Houston, doing all his undergraduate work at night as he worked during the day. He earned a bachelor of arts degree in 1946 and later became the University of Houston's first graduate ever to be admitted to Harvard Business School. He received an MBA from Harvard in 1948.

In the intervening years, Jack held many positions in this town, but in 1966 Jack resigned from a top position in the White House to become only the third president of the Motion Picture Association of America, MPAA. He held this, his most famous position, for 38 years before retiring in 2004.

As president of MPAA, Jack arbitrated one of the most famous developments the film industry has ever come out with--the voluntary rating system. The ratings ``G,'' ``PG,'' ``PG-13'' and ``R'' have become staples, not only in the movie-going practices of every American but also in our Nation's cultural consciousness. However, more important than the societal notions and the cliched images associated with these ratings is the real assistance that this system has provided to parents and families in evaluating the appropriateness of various movies. Indeed, the MPAA rating system pioneered by Jack Valenti has become a prime example of the effectiveness of industry self-regulation without government intervention, and I am very grateful for Jack's work in this area even when many in his industry fought him along the way.

In addition to pioneering the rating system, Jack Valenti also worked to advance the film industry into the 21st century. Indeed, during his tenure at the MPAA, he presided over unprecedented changes in the worldwide film industry, including the advancement of the digital era. I remember having several conversations with Jack as the film industry struggled to deal with the new challenges presented by digital distribution of their content. Together, Jack and I worked tirelessly to balance the competing demands of consumer's rights and the protection of one of America's largest exports--entertainment.

With Jack's help, we were able to refocus the Federal Government's resources to more effectively protect the creative genius of a great American industry--the film industry. We all know how blatantly some bad actors around the world pirate America's movies and rob the United States of jobs. Thanks to Jack's efforts, we have made great strides in this area and laid the groundwork to allow us to stamp out this criminal activity in the years ahead. Combating the theft and piracy of intellectual property was a real passion for Jack, and I was privileged to work with him in this endeavor.

Mr. President, those of us who knew Jack Valenti personally will always remember him as a charitable man who was devoted to his family. While his influence on the film industry has been famous and unmistakable, many of us will remember him more for the personal friendship we shared with him. I will miss him greatly.

Mr. President, I rise today to introduce an important resolution designating the 30th day of April 2007 as ``Dia de los Ninos: Celebrating Young Americans.''

Nations throughout the world, and especially within Latin America, celebrate Dia de los Ninos on the 30th of April, in recognition and celebration of their countries' future--their children. Many American Hispanic families continue the tradition of honoring their children on this day by celebrating Dia de los Ninos in their homes.

The designation of a day to honor the children of the Nation will help us affirm the significance of family, education, and community. This special recognition of children will provide us with an opportunity to reflect on their futures, articulate their dreams and aspirations, and find comfort and security in the support of their family members and communities. This resolution calls on the American people to join with all children, families, organizations, communities, churches, cities, and states across the Nation to observe the day with appropriate ceremonies and activities. In the past years in my state of Utah, there have been a number of events and special programs for Dia de los Ninos in schools, libraries, cultural centers, and even hospitals.

Joining me as original cosponsors to this Resolution are Mel Martinez, Jeff Bingaman, Ken Salazar, Robert Menendez, and Barbara Boxer.

I urge my colleagues to join us in passing this resolution.

Mr. President, today I rise to speak on a question that continues to weigh rather heavily on my heart. I am reluctant to ask it since such a question would never have been asked, or even contemplated, by previous generations of Americans. But it is a question that now must be asked since it is central to our future: Do we, as Americans, have the resolve to see our commitments through? It is a question we must confront in a number of policy arenas that will directly affect the way we, our children, and our grandchildren will live in this new century. Do we have the resolve and the courage to meet our commitments and confront the looming crisis of Social Security?

Do we have the resolve to balance our Nation's budget? Do we have the resolve to endow our children with a proper education so they can master and push the limits of science, thereby providing our Nation the means to compete in an increasingly competitive world economy?

However, at this point in our Nation's history, the crucial question concerning our resolve as a nation does not relate to matters of domestic policy. It relates to our commitments beyond our borders. It is the central and critical component in determining who will prevail in the global war on terrorism. Will we, our coalition allies, the people of Iraq and their elected Government, emerge victorious? Or will we renounce and abdicate our commitments and responsibilities to the Iraqi people--leaving them to a fate controlled by terrorists and leaving our future security as a nation in peril?

Generations ago that, unto itself, would be a stain on the honor of this country; but these are different times.

Turning our back now will only provide our enemies with a new base of operations, and unlike Afghanistan, this base contains vast oil wealth. Imagine al-Qaida with billions of dollars to do with as Osama bin Laden wishes. I wonder what they will buy with all that money. Remember, shortly after the liberation of Kabul, there were numerous media reports that al-Qaida was working on chemical weapons.

So, with that in mind, I again ask: Do we have the resolve to see our commitments through?

As we seek to answer this question, I am reminded of events that occurred during the summer of 1940. The Nazi armies, seemingly invincible, had conquered Western Europe. France, the Netherlands, Poland, Denmark, Norway, and Belgium had all fallen.

The British Army, after its rescue from Dunkirk, no longer possessed sufficient numbers of artillery and tanks to defend against the blitzkrieg. All that stood between Hitler and complete victory was the English Channel and 650 fighters of the Royal Air Force.

Then Hitler offered a deal. In exchange for a ``free hand in Europe,'' the Nazis would provide ``guarantees'' that they would not invade Great Britain.

Despite the fact that the British Army lacked sufficient equipment to effectively repulse an invasion, Prime Minister Churchill resolved to keep his nation's commitment to the people of Europe. He would not abandon them.

His words, which I will paraphrase, still echo today:

The Battle of France is over . . . the Battle of Britain is

about to begin. Upon this battle depends the survival of . .

. Western civilization. . . .The whole fury and might of the

enemy must very soon be turned on us. Hitler knows that he

will have to break us . . . or lose the war. If we can stand

up to him, all Europe may be free. . . . But if we fail, then

the whole world, including the United States . . . and all

that we have known and cared for, will sink into the abyss of

a new Dark Age made more sinister, and perhaps

more protracted, by the lights of perverted science. Let

us, therefore, brace ourselves to our duties and so bear

ourselves that . . . men will say--This Was Their Finest

Hour.

This is the lesson that history teaches us: that resolution to see your commitments through is what great statesmen and nations are made of--that peace and justice can only be restored through bold action.

So what do my colleagues on the other side of the aisle offer, knowing full well this lesson of history? In a word: defeat. In his own words, the Democratic leader said on the floor of the Senate, on April 19, the ``war is lost.'' To be fair, the leader did attempt to temper his words by saying:

As long as we follow the President's path, the war is lost.

But there is still a chance to change course and we must

change course. No one wants us to succeed in the Middle East

more than I do. But there must be a change of course.

So what plan, or new course, does the Democratic leader or other Democrats offer? How can we, in his words, ``succeed in the Middle East''?

His answer can be found in the conference report to this bill. But I warn anyone who attempts to read this legislation, first you must wade through billions in spending allocated to projects and programs that have nothing to do with the war before you learn how our Democratic colleagues plan to ``succeed in the Middle East.''

What is their plan for victory? Well, their legislation states that no matter what happens, the bulk of our forces will begin to withdraw after July 1, or if the President makes certain certifications, after October 1.

So what is their strategy? I believe Winston Churchill would have characterized the Democratic strategy as: guaranteed defeat.

Is this resolve?

Is this determination to see our commitments through?

No.

This is the worst case of capitulation to appeasement since Neville Chamberlain spoke the words ``peace in our time.''

What is needed now is leadership. Now, at this critical moment in history, great nations need to follow Churchill's advice, yet the Democrats offer us only Chamberlain's.

The Democratic leaders previously stated, in 2005:

[A]s far as setting a timeline . . . that's not a wise

decision because it only empowers those who don't want us

there, and it doesn't work well to do it.

Wise and sound words. That was real leadership. Unfortunately, that was when the polls supported their position to stand firm. Now the Democratic leaders have reversed themselves because the polls have told them that is what they should do.

Two days ago, during an interview on CNN, the Senator from Nevada was asked if he would believe the words of our new commander General Petraeus ``that there is progress going on in Iraq, that the so-called surge is working. Will you believe him when he says that?''

What was his response? ``No, I don't believe him, because it's not happening.''

Now, I find this to be an incredible remark. Less than 3 months ago, the majority leader had joined a unanimous Senate and voted in favor of General Petraeus. But this was more than just another confirmation vote. The major subject of his confirmation hearing and the subsequent debate on the Senate floor was the new strategy the general had outlined.

So what is the new strategy? Simply put, General Petraeus is executing one of the tenets of a classic counterinsurgency strategy by providing and maintaining security to the local population and neighborhoods in Baghdad. Only when this is achieved will the Iraqi Government be able to continually offer basic services such as clean water and electricity, which are the backbone of any modern society.

This, in turn, creates conditions where the Iraqi people can begin to develop a growing economy and where families feel safe to send their kids to school. As these goals are achieved, more and more of the population will desire even greater stability and will support and work toward creating Iraqi Government institutions and security services that maintain and enhance this new, secure environment.

How is this different from the past? Previously, U.S. forces would clear an area of insurgents, but, unfortunately, soon thereafter, our forces would leave and the insurgents would return. Now, under General Petraeus's plan, American and Iraqi security forces will

maintain security in the cleared neighborhoods of Baghdad. To date, over 50 security force units, based in what are called garrisons, can be found in the neighborhoods of the city, and even more are planned.

That is why the additional forces that we are sending to Iraq are vital. It is not more for more's sake, but to maintain a secure environment for the Iraqi people and to help them stand up for themselves.

Based upon the briefing that the Senate received yesterday from General Petraeus, and information I have examined as a member of the Senate Intelligence Committee, I can report that we are seeing signs of progress.

Frankly, I believe the changes that have been made in the last 3 months are remarkable and need our full support, and it is readily apparent we do not yet have all the promised forces deployed and in Iraq.

So let us return to the question that I asked when I began my remarks: Do we, as Americans, have the resolve to see our commitments through? Or will we falter?

That is what the vote on this conference report will demonstrate. Will we stand with firm resolve behind our commitments and see our new strategy through? Or do we adopt a policy of appeasement and hope that al-Qaida, and those who wish us harm and seek to destroy the values that we hold so dear, do not follow us home to our country?

What side of history do you wish to be on? Based on America's history and our resolve that has seen us through so many difficulties in the past, I believe the American people do not want retreat, they want success and security.

Mr. President, today I wish to pay tribute to SPC Eric R. Sieger of Layton, UT, who died of injuries suffered while conducting operations in Iraq. He was a remarkable young man who overcame much adversity in his life. On March 9 of this year, he would have turned 19 years old.

Part of the 1st Cavalry Division, Specialist Sieger was also a member of a very special family. I understand that his parents, Wolfgang and Krista, have 15 children, 6 of whom were adopted, including the Specialist. Early life was not easy for the Specialist but that all changed when he was adopted at the age of 11 by the loving Sieger family.

I have been informed that Specialist Sieger enjoyed running, being with his friends, building and fixing things. He had a girlfriend whom he met while stationed at Fort Hood, TX. Shortly before his passing, Specialist Sieger was able speak to his mother on the phone. His mother said, ``They spent most of the time laughing and joking with each other.''

Specialist Sieger's father said, ``He was dutiful in wanting to do what is right.''

Undoubtedly, this led him to become a member of the Civil Air Patrol as a teenager and enlist in the Army at 17. Military service is a calling for other members of the Sieger family, as well. Currently, one of his sisters is also deployed to Iraq, another sister is preparing to deploy, and a brother is a member of the Air National Guard.

I would like to conclude my remarks by quoting the words of Specialist Sieger's mother and father. Krista Sieger stated, ``He felt since he was in the Army, since he took the oath, he has to do everything he was asked to do. And he did.'' Wolfgang Sieger said, ``I would call him a hero. He is definitely a hero in my sight. I honor him as a hero.''

I do not know of any higher praise that parents could give a son in military service. Specialist Sieger and his family will always be in my prayers.

Sergeant First Class Douglas C. Stone

Mr. President, I wish to honor one of Utah's fallen sons, SFC First Class Douglas C. Stone.

SFC Stone had a lifelong connection to our Nation's military. His father served in the Air Force. Yet, SFC Douglas Stone joined the Army Reserve later in life. As his mother Dolores Feigley said about her son, ``I think he was the oldest at boot camp.''

However, his maturity was only to be an asset to his country, which was affirmed when he became a full-time reservist. Over the past 6 years, SFC Douglas Stone assisted in the preparation of reservists from the 96th Regional Readiness Command for deployments in support of Operations Enduring Freedom and Iraqi Freedom. As my good friend, MG Peter S. Cooke, the commanding officer of the 96th Regional Readiness Command said about SFC Stone ``There wasn't a unit or individual sent from our headquarters that SFC Stone did not personally assist in preparing for their mobilization or deployment.''

This was not the first time SFC Douglas Stone had gone in harm's way for his country. He also was a part of the fuel re-supply effort during the First Gulf War.

However, his life's most important work undoubtedly was as a family man. Sergeant First Class Stone was husband to his wife, Mary, and father to two boys Nathan, 13, and Cameron, 10.

SFC Douglas Stone was also a member of Fort Douglas's Honor Guard. I understand that Rick Edginton, one of his fellow Honor Guardsmen who participated at his friend's funeral said, ``for me, probably one of the toughest moments was when I was standing at the head of the casket and I looked over to the side and I saw a note from his sister on the flowers that were there. It said, ``To Doug, my brother, and my Hero.''''

No truer words have been written.

SFC Douglas Stone was a hero. He served his country with pride and answered its call when it needed him most. All of Utah shall remember him and will be praying for this hero and his family.

Sergeant Brandon A. Parr

Mr. President, today I wish to pay tribute to SGT Brandon A. Parr. Sergeant Parr was a member of the 630th Military Police Company and gave his life with two other servicemembers when their vehicle was struck by an improvised explosive device.

There are certain pictures that define a time and a moment in our Nation's history. Such examples can be found in the raising of Old Glory over Mount Suribachi, Iwo Jima. I respectfully submit that a picture taken during Sergeant Parr's funeral should be added to that category. In that photo, Sergeant Parr's wife, Shannah, is seen holding the hand of their young son, Nicholas. Nicholas, standing on some steps, is wearing the camouflage uniform of an American soldier--a young son's tribute to his fallen father. This is an image that I will remember for all my days and a fitting tribute to a true hero.

Sergeant Parr enlisted in the Army in 2003, and this was his second tour in Iraq. He was involved in one of the most critical tasks in this war: training Iraqi police and providing security to the Iraqi people. By all accounts, Sergeant Parr preformed these assignments at the highest standards of our Nation's military.

Shannah Parr said of her husband, ``He was very laid back and very funny. He made everyone feel good.''

His mother, Teota Dangel said, ``I think he would have gone (to Iraq) even if he knew this was going to be the outcome.'' Words like this can only be spoken of a true hero and patriot.

Sergeant Parr and his entire family will always be in my prayers.

Corporal Stephen Kowalczyk

Mr. President, I wish to pay tribute to CPL Stephen Kowalczyk, a member

of the 1st Calvary Division, who recently lost his life while on patrol in Iraq.

Upon learning of about his life, I was struck by all the adventures that Corporal Kowalczyk had undertaken. He had been the captain of the swim team at Macalester College, traveled extensively throughout Europe, the Middle East, including working as a handyman in Jerusalem. I understand that he even leapt from an iceberg and swam in the frigid waters of the Arctic Ocean. Clearly, this was a young man that seized all that life had to offer.

Three years ago, at the age of 29, he began a new adventure and joined the Army. According to his family he loved it.

During a recent memorial service in Iraq, one of his comrades SSG Richard Coombes stated: ``He was a man who taught me that there was still beauty in our everyday life, even in Iraq. I looked at him and wondered if he had already figured life out. He was in such peace and harmony.'' CPT Kevin Bradley would often notice that Corporal Kowalczyk would look from the roof-tops at the area around him. When asked why, he reportedly would reply, ``You should see it up here. It's beautiful.'' Another friend remembered him as ``a gentle, kind soul, I cannot think of anybody who did not love this man.''

And yet he never forgot why he was deployed to Iraq--to help the Iraqi people. This commitment was reflected in the letters that he would write home asking for history books that he could give to Iraqis that he met, and pencils, notepads, and Hershey bars for Iraqi children.

What a fine man. What an extraordinary life.

I will always remember him and his family in my prayers.

Mr. President, I yield the floor.

Mr. President, I have an amendment to S. 761, the America COMPETES Act. My amendment would allow competency-based institutions of higher learning to access grant programs which will help them train math, science, and critical foreign language teachers.

I applaud the goals of increasing the numbers of math, science, and critical foreign language teachers in our schools, including high-need schools. Our ability to compete as a nation is directly tied to our ability to educate our young people and retrain those who are in industries that are no longer viable.

We now have the finest system of higher education in the world. There is no doubt that if we provide the proper incentives, many brilliant innovators and educators will take up the clarion call.

I come before this body today to introduce my amendment because many of today's teachers are teaching an older generation of students. The U.S. economy is in a state of continual change, and with that change comes displacement of workers and a need to retrain and retool. These nontraditional students often receive their training from accredited schools who assess student development based on a student's ability to demonstrate competency in the material being taught. Under the bill as drafted, these competency-based universities would not be able to access the grant money for teacher development. My amendment would remove this bias and allow competency-based universities access to the teacher development grant money. This in turn will increase the teaching quality in math, science, and critical foreign language, thereby providing the students attending these universities with a better education.

Current bill language would prevent participation by well-respected and widely recognized institutions, such as Western Governors University, WGU. WGU was set up by over 19 Governors to provide innovation in higher education and is now training over 1,000 math and science teachers, the majority of whom are women and minorities. WGU's innovative approach to teacher education has proven very successful.

As we set about to ensure that our Nation has the needed highly qualified teachers in critical subject areas, we must make certain that these institutions are included in this legislation. Therefore, I ask my colleagues to join me in supporting this amendment.