A concurrent resolution correcting the enrollment of H.R. 2863.

Mr. President, reserving the right to object, I had requested in the time that was requested 15 minutes. That is clear. Furthermore, reserving the right to object, I ask unanimous consent to amend the resolution to strike division E, the Public Readiness and Emergency Preparedness Act. This is the provision that provides drug companies with unprecedented immunity from liability which was added to the Defense appropriations bill in the conference during the middle of the night. It does not belong in this bill. I ask unanimous consent.

Mr. President, will the Chair remind me when I have 3 minutes remaining?

Mr. President, over these last several months in the Senate we have addressed the issue of a potential epidemic, the pandemic flu. There have been two areas of leadership. One has been in our HELP Committee under the chairmanship of Senator Enzi and Senator Burr, where we have tried to work out a whole approach to deal with the area of epidemics and bioterrorist attacks, and another with the leadership of Senator Harkin, who had asked that we commit some $8 billion to be able to purchase vaccines and also antiviral drugs for influenza.

I attended the NIH announcement by the President of the United States when he actually requested $7.1 billion to prepare for a flu pandemic. Those funds were going to be used for public health, first of all, to be able to detect flu outbreaks overseas; secondly, to be able to detect them here at home; then to be able to build containment capacities, what we call ``surge'' capacity; and, also to have a generously funded vaccine program, and also an antiviral program.

That is really where we were before the Defense appropriations bill.

A number of us on the HELP Committee had a series of negotiations to try to make a bipartisan recommendation to the Senate. We did so on pensions, on higher education, on workforce, and on Head Start. We were able to do so in a number of different areas. And we were moving ahead toward making a recommendation in issues related to the purchase of vaccines and antivirals. There are two important issues to consider with the purchase of pandemic influenza vaccine and antivirals. One is the danger to an individual that is going to take those vaccines or antivirals; and the other is the risk those dangers raise for the companies that produce them. One is the compensation issue, and the other is the liability issue.

We have dealt with these issues on several occasions. We dealt with them with respect to the swine flu. We dealt with these issues with smallpox. We dealt with these issues for childhood vaccines.

One thing we know from experience is, if you do not have an adequate compensation program, no matter how much money you put in for the purchase of vaccines or of antivirals, the program is not going to work. There has to be an assurance that, if first responders and others are going to go out there and take their chance with these new vaccines or other drugs, that if they become grievously ill or sick or even die there will be some compensation for them and for their families for lost wages and medical costs and the like. And there has to be the assurance to the first responders and others that those vaccines are not going to be produced negligently. Otherwise, they will not take the risk of using the vaccines or drugs. That is the framework.

We have to ask ourselves, for the liability and compensation provisions that have been put in the Defense appropriations bill, how do they line up with what has been successful in the past, with bipartisan efforts? These provisions fail in every respect of the word.

First, there is a compensation program that is not funded. It is not funded. It will depend upon future appropriations. If you want to buy a pig in a poke, buy that particular provision. All you have to do is ask my friend from Utah, Senator Hatch, how we have funded the compensation program for the downwinders. Over a long period of time, we did not have the required payments for them, when we know, as a direct result of governmental action, we adversely affected tens, even hundreds, of thousands of downwinders in the State of Utah and in the West more broadly. We have not measured up to our responsibilities to them, and the compensation program before us now is no more adequate. And as a consequence, this compensation program is not going to work.

Not only that, what have we done with regard to the manufacturers? What kind of immunity have we given to them? It's really extraordinarily broad, effectively complete. What they call the ``bad actor'' provision describes the circumstances in which the immunity from liability fails. And it's really very narrow, because a company's actions have to meet a very narrow definition of willful misconduct.

Page 12 of this 40-page liability section says in order to have any kind of liability, you have to have willful misconduct. This is an act or omission that is taken intentionally to achieve a wrongful purpose; knowingly without legal or factual justification; and in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.

As if that isn't clear, and narrow, enough, on the same page, underneath this language, is a rule of construction. This rule says that this language establishes a standard for liability more stringent than a standard of negligence in any form or recklessness. So companies are not deterred from acting recklessly, or with gross negligence.

Now that is pretty narrow, but apparently it isn't narrow enough. Right here on page 12, it says that the Secretary of Health and Human Services, in consultation with the Attorney General, must issue regulations that further restrict the scope of actions or omissions that may qualify as willful misconduct.

So ``willful misconduct,'' which should just mean intentional, isn't good enough.

Well, at least we have solved that, right, to make it as narrow as possible? Wrong. Go down to the standard of evidence. The bill changes the standard of evidence in the various trials, to ``clear and convincing evidence.'' That is at the bottom of page 13.

The bill defines a very narrow standard of willful misconduct, and it sets a very high standard of evidence. Shouldn't that be enough? Wrong. You don't have a case against a company under these provisions unless the FDA begins an enforcement case against that company. So if FDA goes ahead and begins the case, you have a chance, right? Wrong again. FDA has to bring it and conclude it successfully before you have any right to proceed with your case.

A person might think, I am not very satisfied with how this liability provision has worked, maybe I will appeal to the courts of this country, right? Wrong. There is absolutely no, no, no, no judicial review when the Secretary of Health and Human Services grants a company immunity by issuing a declaration. No judicial review of that. And there is no judicial review of FDA's decision not to bring an enforcement action. So it is whatever the administration says, whatever the Secretary says, whatever the head of the FDA says, with changed and gimmick rules. This is a sham. There is no possibility of liability here.

Now, we would say, OK, this is bad, but this liability protection is limited to just a few products, right, products that few of us will ever have to use? It actually applies to products--vaccines, drugs, diagnostic tests--for epidemics. We rarely have to worry about epidemics, right? Well, who defines ``epidemics''? It is rather interesting who defines epidemics. Senator Domenici says diabetes is an epidemic. Senator Frist himself says meth abuse is an epidemic. Bill Frist himself said obesity is an epidemic. Senator Bond says arthritis is an epidemic.

This week in Newsweek Magazine, the Secretary of Health and Human Services, who is going to enforce this provision, says this:

We're seeing an epidemic of chronic diseases. Obesity is

just one example.

So how many diseases are going to be considered epidemics? A lot, perhaps, but at least we say that is all right, because it is just going to apply to drugs for that particular epidemic disease, right? Wrong again. This provides the same kind of liability protections for any of the drugs or anything else that deals with the side effects of the products for that epidemic disease.

My goodness. Generally around here we measure who the winners are and who the losers are. And we have seen over the last year and a half how the drug companies come out on top, time and time and time and time again. But never, never, never, ever, ever like they have with this sweetheart deal that was stuck into this conference report after the assurances had been given to the conferees that there were no provisions in it with regard to liability.

The Medicare drug law made it illegal for the Government to negotiate prescription drug discounts for seniors. They do it in the VA system, and drug prices for the VA are lower. But we weren't able to permit the government to negotiate drug prices for seniors. The Republican Congress blocked legislation to allow importation of safe and less expensive drugs.

And now we find in this biodefense and pandemic flu provision liability shields for companies that make dangerous drugs, with no compensation for injured patients.

That is a scandal. It has no business being in this bill. The Judiciary Committee requested an opportunity to examine it. It was rejected. We have had no hearings on this particular provision. It is the wrong thing to include in this legislation.

Let me share what one of our colleagues has said about childhood obesity:

The responsibility for this growing epidemic rests with

us--the American consumer. We need to get serious about

fighting fat.

Let me cite you the language of the provision, the broad definition on page 31 of what gets liability protections under this bill. It says: ``Qualified pandemic or epidemic product'' means any drug, biological product, any device to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit harm from the pandemic or epidemic. And the term includes not only those products, but any other product, any other product that is produced to deal with the side effects of those products.

This is a scandal. It is a giveaway. It is outrageous. It is rare, if ever, that we give this kind of privileged status to any industry in the country, and give this kind of authority and power solely to one branch of the Government. There is no second guessing. There is no judicial review. There is no further involvement of the Congress. That is basically and fundamentally wrong and we are asking and committing $3.7 billion to go down this road. It is outrageous and it is wrong.

I am sure that as soon as the Secretary of Health and Human Services issues what is called a declaration for a pandemic or epidemic to give immunity from liability to vaccines or other products, there is going to be a charge to the courts. The constitutionality of this provision is going to go into the Federal district courts and the circuit courts of appeal.

Included in the Record is legal authority that I believe shows that this provision, the way it is drafted, is absolutely unconstitutional because of the indefiniteness of the criteria under which the executive branch makes decisions and because there is the real possibility and likelihood of serious injury to individuals without any right to go to court or for judicial review of declarations.

This provision is going to be challenged along the way. We want to tell those in the bio industry--and they are healthy in my State and I have worked with them--if you want to work with us to get an effective compensation program, as we did in the past with smallpox or childhood vaccines, if you want to get an effective provision to deal with liability, one that is responsible and that responsible drug manufacturers will welcome, then we are more than willing to welcome you and to work with you.

But I think we can be certain that this provision will not be effective, and it is misleading the American people to say we are making a downpayment in the development of vaccines for the reasons I have mentioned this evening.

Slipping a provision into a major spending bill late at night at the end of Congressional session is a trick to shield from public debate a provision that is so wrongheaded that it would never stand public scrutiny.

The Republican congressional leadership has snuck yet another special favor to drug companies into the defense appropriations bill.

It is an outrageous provision that has nothing to do with protecting our troops, and it should be dropped from the bill.

This provision allows drug companies to flagrantly disregard basic safety measures in making a broad range of drugs or vaccines, while giving patients who are injured by shoddy products only an empty promise of compensation.

It is cynical to claim that this is what is needed to deal with avian flu.

Drug industry advocates will say that this debate is about trial lawyers, and we have heard phrases like ``jackpot justice'' and ``runaway juries,'' and tales of endless lawsuits against the firms that make the vaccines. But that couldn't be further from the truth: Senator Dodd and I offered a plan that included important legal protections for drug companies that make experimental flu vaccines and other drugs needed to respond to a pandemic or a bioterrorism attack as well as a compensation program modeled after the Vaccine Injury Compensation Program that already works well for childhood vaccines.

Our proposal follows the successful examples of the past. For swine flu, for the smallpox vaccine and for childhood vaccines, the Government has set up a way to compensate the injured. Whenever Congress has provided an alternative to liability in the past, there has always been an assured means for patients to receive compensation.

The current proposal violates that past practice.

It twists and turns the law to stack the deck against patients, and abrogates basic principles of judicial review. It is no wonder the provision's authors hid it from public debate and didn't let the Senate Judiciary Committee even look at the proposal before it was jammed into the massive conference report.

If they had allowed our Judiciary Committee to examine this proposal, we would have quickly seen its constitutional flaws. I received a detailed analysis of this provision from Professor Erwin Chemerinsky, who is the Alston and Bird Professor of Law and Political Science at the Duke University School of Law.

According to his analysis, the provision gives the Secretary of HHS ``unfettered discretion . . . to grant complete immunity from liability'' while also ``depriving all courts of jurisdiction to review those decisions.''

Professor Chemerinsky has found three areas in which the provision infringes the Constitution.

First, the provision delegates powers to the executive branch without the limitation of a prescribed standard. It is an extraordinarily broad delegation--the Secretary decides when to declare emergencies, what diseases or threats to health are covered, which drugs or products will be immunized, which individual citizens lose their right to go to court and recover for injuries caused by the drugs or products, the geographic area in which these rules will apply and the length of time they will apply. This violates the nondelegation doctrine, which says that Congress my not delegate its legislative authority to the executive branch without clear guidelines.

Second, it violates federalism principles by improperly intertwining Federal and State law, making a new Federal cause of action that depends on State law. It also makes the Federal cause of action depend on the FDA or the Attorney General taking an enforcement action. It is a violation of due process, however, to allow official inaction to prevent a person from pursuing his or her rights in court.

Third, the provision completely prohibits judicial review of declarations that provide drug companies with immunity.

The U.S. Supreme Court has repeatedly stressed that the preclusion of all judicial review raises ``serious questions'' concerning separation of powers

and due process of law. Judicial review of government actions has long regarded as ``an important part of our constitutional tradition'' and an indispensable feature of that system.

I reserve whatever time I have remaining.

Mr. President, I rise to make a few remarks concerning the Public Health and Emergency Preparedness Act of 2006 which was inserted in a year-end appropriations vehicle, the Department of Defense Appropriations Act.

Protecting the American public against acts of bioterrorism like the 2001 anthrax attacks and natural disease outbreaks such as the risk posed by the avian flu is an important national security priority.

For 4 years, I have worked in a bipartisan manner with my friend from Connecticut, Senator Lieberman, on comprehensive legislation to address this concern.

We have vetted our proposal with literally hundreds of experts over the last 4 years.

We understand full well that our proposal contains a number of bold proposals that challenge our colleagues to make fundamental changes in our biomedical research, public health management, regulatory, antitrust, intellectual property, tax and civil liability systems toward the end of materially increasing our Nation's public/private sector capacity to design, develop and distribute hopefully hundreds of new products to counter the effects for the dozens of known biological, chemical or nuclear threat agents for which we today literally have no diagnostics, vaccines or therapeutic responses.

This is a tall order.

It will likely take 20 or more years to build this capacity to the level we will need to discourage our enemies from attacking us in this manner or, if they do so, to be able to respond in the way that the public will expect to ensure the strength of American society.

We have made some progress in recent years but we have to do much more in this area.

This is the type of issue that takes time, money, creative energy and patience.

We need a Manhattan Project type of effort, and we needed it 4 years ago.

Throughout my years in the Senate, I have worked on dozens of important public health bills.

In my experience, public health bills go better if they are done on a bipartisan basis.

I have also observed over time that, generally speaking, good public health policy turns out to be good politics. I know of no disease or condition that chooses its victims along party lines.

I am pleased that a key concept of the legislation that we introduced in 2002, the ``guaranteed market'' for those firms that successfully develop certain bioterrorism countermeasures was finally adopted in the Bioshield I legislation passed in the 108th Congress.

In the first session of the current 109th Congress, there has been a great deal of interest in bioterrorism and pandemic diseases. This is good for the American public.

In the Senate, the HELP Committee was infused with new leadership on this issue in the persons of our new chairman, Senator Enzi, and the chairman of the new Bioterrorism and Public Health Preparedness Subcommittee, Senator Burr. Majority Leader Frist and former Chairman Gregg have continued their longstanding involvement on these issues.

Across the aisle, led by a veteran leader in public health issues who has been on the HELP Committee or its predecessors for 43 years, Senator Kennedy and others including Senators Harkin, Dodd and Clinton have been interested in these issues.

Throughout the Spring of this year the Bioterrorism Subcommittee held a series of bipartisan hearings and discussion roundtables that were attended by leading experts. Throughout the August recess the staffs of the committee members worked on various drafts of bioterrorism legislation that culminated in a markup in September.

Unfortunately, from my perspective, the bill that resulted from the HELP markup did not contain the intellectual property and tax provisions that Senator Lieberman and I have long advocated. Such is the reality of the dance of legislation. But, as has developed in the provisions related to the guaranteed market, liability, and compensation, we believe that the day will come when these ideas from our original legislation are also seen as meritorious.

Subsequent to that markup, the Bush administration unveiled its comprehensive plan to prevent and respond to the potential catastrophic outbreak of human-to-human avian flu transmission.

Throughout the Fall, many Members of Congress, the administration, industry, the public health community and other interested parties worked on various pieces of legislation to respond to these threats. Unfortunately, as sometimes happens at the end of very busy congressional sessions, not everyone was able to work together at the same time.

For a variety of factors, we have now arrived at a point where a potentially integral piece of an effective legislative response to bioterrorism and pandemic threats has been inserted into the Department of Defense appropriations bill. Using year-end appropriations bills as vehicles can be an opportunity to solve important problems but, sometimes, can pose a risk that an inadequately vetted measure becomes law.

As many who are not members of the esteemed Appropriations Committee, I have a preference for the regular order of the authorization process. In all candor, from time to time in my career, I have availed myself of appropriations vehicles to move authorization bills that I desired to see passed. Sometimes, as shocking as it sounds, there is gambling in Casablanca.

Comes now the newly drafted, and redrafted and redrafted, Public Readiness and Emergency Preparedness Act.

Both Senators Frist and Gregg must be singled out in the Senate for their efforts to develop and move this new bill. In the House, I understand that Speaker Hastert and Chairman Barton, even as he was hospitalized, are largely responsible for this effort.

All of these good and earnest members should be recognized for attempting to tackle two of the most vexatious policy and legal issues confronting us in this critical area: liability; and compensation reform.

We need to encourage the private sector to work vigorously on scores of new, potentially dangerous drugs and biological products designed to counter both natural and bioterroist threat agents. That is what liability reform is all about.

At the same time, if some of these products--some of which will never be tested in human clinical trials since it would be unethical to infect a patient with a microbe like the Ebola virus just to see if a potential treatment were safe and effective--turn out to injure and even kill patients, there must be a fair and funded system of compensation.

Some critics are already falsely charging that these new provisions are nothing but a Republican gift to the drug industry during the Christmas season.

Hogwash.

There should be no doubt that the sole intention of the principal drafters of this legislation is to help devise a system that will increase the readiness of our country to respond to bioterrorist or natural public health threats.

I also think it is way past time that Members of this body and others stop unjustifiably vilifying the pharmaceutical industry. Due in large part to the unique partnership between the public and private sector biomedical research enterprise--undergirded by the substantial annual $28 billion taxpayer investment in the National Institutes of Health-- we are on the verge of a revolution in our understanding of human health and disease. Let's just hope that neither the avian flu not the bioterrorists strike before we have developed the means to defeat these threats.

We will not defeat biological enemies with bullets or battleships. It will be accomplished with basic biological knowledge and the applied know-how required to translate ideas from the lab to the patient's bedside.

Integral to this system and to our national security is the too often-maligned pharmaceutical industry.

They are tough, profit seeking companies. They are often their own worst enemies. They are not always right.

But nor are they always wrong. The products they produce are aimed at

preventing and treating diseases and reducing suffering. And that is not the worst business to be in by any means.

The situation is that we are confronting an enormous chicken-and-egg problem in developing new vaccines and countermeasures due to the fact that in the last several decades product liability exposure has drastically reduced our domestic vaccine production capability. I understand that in 1976, 26 companies produced vaccines for the U.S. market. This year, only five companies produce vaccines sold in the U.S. and only three have U.S. production facilities.

This constitutes both a public health and national security challenge that must be addressed.

While I have concerns about many of the precise provisions in this new language, I recognize and commend my colleagues for attempting to solve a problem that needs solving.

I have great respect for the majority leader, especially as he attempts to navigate this year's exceedingly complex package of pending bills which include the budget reconciliation bill--the first such measure in nearly 10 years--the PATRIOT Act, the Labor-HHS appropriations bill, as well as the Department of Defense authorization and appropriations bills. This is a tall order by any standard.

Although I urged the Leader not to include this new bill in the year- end legislation, I told him that I would not vote against this measure if it were part of one of the year end, must pass vehicles.

I did this largely out of deference to our majority leader.

For reasons that I will explain, if it came to a simple up-or-down vote on this measure as currently drafted, I could not yet support it and would vote no.

If this measure does in fact become enacted into law, I will be open to considering further modifications in this language should our study of this new language indicate that changes are advisable.

Many will question whether this bill, in its current form, contains too much indemnification and not enough compensation. This is a fair question.

For example, the funding mechanism in the bill does not appear to be guaranteed.

I have been down the hard road of discretionary funding with respect to the Radiation Exposure Compensation Act, which I authored, and I cannot say that I would recommend such an important program to be subject to the uncertainties of less than stable, certain funding.

Still others will question why the bill provides for no judicial review, apparently even by the United States Supreme Court, for certain actions by the Secretary of Health and Human Services?

There will be concern that the bill does not allow adequate judicial review to assure that the Secretary has not acted either arbitrarily or capriciously in certain circumstances.

Because of the great significance of this measure, I suggest that Chairmen Enzi and Specter hold hearings on this language once the Congress reconvenes after the holidays.

It is, for example, important to learn what the administration thinks about this new bill and whether, upon reflection, it would urge some refinements.

I have not seen a Statement of Administration Policy on this measure.

Nor have I seen a Congressional Budget Office score so it is a little unclear to me how much this new section would cost.

The administration will be called upon to administer a new compensation program and we need to know how they plan to implement this program and whether they have any suggestions to improve the operation of this program.

As well, I would not be surprised if more Members and other interested parties will want to weigh in on the structure of the new compensation program, which is based in large part, on the current smallpox vaccine injury compensation program.

As our experience with the asbestos legislation teaches us, there is always great interest in the level of compensation injured citizens may receive, especially if they give up their possible tort remedies.

I note that there is a higher standard imposed upon the Secretary in constructing an injury table under this new bill than must be met under the current smallpox vaccine injury compensation law. Many will want to know exactly what is intended and what the practical effect of this new standard will be on the health experts who will advise the Secretary in this critical area.

There are also many questions that must be explored with respect to how the liability shield will operate in practice.

Let me state clearly that I favor a strong liability shield so that many pharmaceutical and biotechnology firms will enter this critically important field of research and development. The fact is today that there exists a pervasive climate of apprehension about product liability and litigation exposure and this is chilling the necessary private sector activity.

Clearly something must be done. It is not so clear that the new liability language is yet as good as it needs to be. For example, the way in which the willful misconduct and FDA defense provisions operate together in the context to potential court challenges merit particular attention. As well, the policy and business-behavioral ramifications of drawing a hard line between all forms of negligence and wilful misconduct deserve careful thought and analysis.

In the case of dual use products, such as antibiotics, it appears that, should a bad batch of drugs be made due to ordinary negligence, a patient injured when taking the product for a normal, garden-variety infection will have a much greater range of legal remedies than a person who took a pill from the same adulterated production batch but under a Secretarial declaration of a public health remedy. It is not readily apparent why this should be the case.

There may be ways to further improve and refine these provisions and other parts of the bill as well. For example, consideration is warranted with respect to whether there ought to be a subrogration provision in certain cases when the Federal Government must compensate patients for injuries caused by negligent or grossly-negligent actions of manufacturers, distributors, or others connected with developing the drug or delivering it to patients.

In any event, I think we should keep an open mind to viewing this new language as something as a work in progress.

Rather than embarking down a path of political who-struck-John on how this new section got into the bill and who drafted this provision or that provision, I think the public will be better served if we focus our future efforts on evaluating what the bill does and deciding whether there are ways we can make it better.

One thing is certain. If we do not find a better way to unleash the creative efforts of the private sector in researching and developing a panoply of new products designed to diagnose, prevent and treat bioterrorist and natural threats, the health and welfare of our Nation cannot be secure.

We have a big job ahead of us.

I urge that we move forward in a constructive, bipartisan effort to further improve the Public Readiness and Emergency Preparedness Act that has been placed in the DOD appropriations bill conference report. If others are willing to proceed in this fashion, I am certain that Senator Lieberman and I, and many others, stand ready to discuss and refine this and any other piece of related legislation.

Mr. Speaker, reserving the right to object, more than a year ago when Mr. Lewis was elected chairman of the Appropriations Committee, he came to me and asked if we could have an understanding that we would express our substantive differences, but still cooperate in moving bills forward in an orderly way once those differences were expressed. We did that.

Time and time again, the minority was denied the opportunity to offer different sets of priorities, priorities that did not offer huge tax cuts for those who have the most in society, paid for with cuts in education, health care, and worker protection for those who have the least. Despite the fact that the rules of the House were used to block our efforts to obtain on-the-record votes on a number of our alternatives, Democrats continued to cooperate procedurally even as we made clear our differences on policy.

The Republican majority wanted to finish all of these bills by the end of the fiscal year, and we did not procedurally obstruct them, because while we differed strongly with the values that lie behind their budget priorities, we respected the fact that they are in the majority, and we respect and revere this institution. But because of internal divisions between the majority party, divisions within the House GOP caucus, and divisions between House and Senate Republicans, the fiscal year ended with the Labor-HHS bill and the Defense appropriations bill that represents 67 percent of the discretionary spending in our budget bill still being hung up in the legislative process.

Now in the closing days of this Congress, the Republican leadership has decided to use the must-pass Defense appropriations bill to force down the throats of the American people a number of wholly unrelated gifts to special interests. They decided to hold funds for our troops hostage in order to force Congress into removing protections against oil drilling in ANWR.

To make room for their tax giveaways, they even imposed a second round of cuts on education, health, worker protection, and even imposed a $4 billion additional cut in military spending. Senate action yesterday has corrected one provision inserted in the bill by the abuse of power, the strong-arm attempts at drilling in ANWR, and for that I applaud the Senate. I led the opposition to ANWR's inclusion in the conference, and I am happy that the Congress was not blackmailed into accepting it.

But, frankly, Mr. Speaker, continuing under my reservation, ANWR was not the biggest problem with the conference report. The biggest problem is that it shortchanges our economic future by refusing to make adequate investments in education. And it cruelly neglects to strengthen support for programs that help provide critical health care services to people who desperately need them.

But we have lost that fight. This Congress has made the decision to cut critical health, education, worker protection, and social service funding by $3 billion below last year's level. What I find so gutless about Congress' performance on this bill is that those cuts could not pass the Senate on a rollcall vote, so the majority party had to arrange for their Senators to duck this vote, thereby hiding from accountability by arranging for the bill to be passed through the Senate without a rollcall vote. That means the majority party has denied critical help to families most in need of help, but has not had the courage to forthrightly defend their votes to the people affected in the public arena.

This bill makes that problem $1.4 billion worse for those programs and because of the across-the-board cut, it makes other ill-advised cuts in critical funding for the FBI and local law enforcement, and it even cuts an additional $4 billion out of the Defense bill. If I could do anything to change that, I would; but it is clear the die is cast.

Continuing under my reservation, Mr. Speaker, there is a second outrageous problem with this bill. The majority has turned the proposal to prepare for a flu pandemic into a giveaway to the pharmaceutical industry. When the President requested $7 billion to begin a much- belated crash program to develop a new generation of vaccines and antiviral drugs to combat a potential flu pandemic, the Republican majority responded by cutting it in half. When I asked Senator Stevens in conference why we shouldn't fund the rest of the administration's request so that it was clear that the government had a long-term commitment to the development of needed vaccines and antivirals, he responded that because liability protection language for manufacturers was not being adopted, long-range funding should be withheld.

The conference committee ended its work with the understanding, both verbal and in writing, that there would be no legislative liability protection language inserted in this bill. And because the majority told us it did not want any compensation program for victims to be applied against the discretionary portion of the budget, no funding was provided for that, either.

But after the conference was finished at 6 p.m., Senator Frist marched over to the House side of the Capitol about 4 hours later and insisted that over 40 pages of legislation, which I have in my hand, 40 pages of legislation that had never been seen by conferees, be attached to the bill. The Speaker joined him in that assistance so that, without a vote of the conferees, that legislation was unilaterally and arrogantly inserted into the bill after the conference was over in a blatantly abusive power play by two of the most powerful men in Congress.

We then discovered that this language provided all sorts of insulation for pharmaceutical companies and that this insulation applied not just to drugs developed to deal with the flu but in fact applied to a far broader range of products. In essence, the provisions allowed the Secretary of HHS to issue a declaration that has the effect of almost completely prohibiting lawsuits in State or Federal courts by persons whose health was injured against manufacturers and various others for compensation for injuries caused by the use of covered countermeasures.

That determination would bar lawsuits against a wide range of covered persons involved with the countermeasures including manufacturers and

their suppliers, their distributors, State and local governments and their employees involved with the use of those countermeasures, medical personnel prescribing and administering the countermeasures, and so forth.

That is very broad power, indeed, to ban lawsuits. Unlike the language requested by the administration, the division E language is not limited to products to combat a flu pandemic. Rather, it applies to any drug, vaccine, medical device, or other products useful in dealing with anything the Secretary considers to constitute a health emergency or that could constitute an emergency in the future.

Although a rationale often offered for lawsuit protection is that it is needed to encourage manufacturers to develop and produce new treatments, the protections of division E are not limited to new or experimental products. Rather, nothing in the language would prevent the Secretary from providing protection against lawsuits to drugs that have been on the market for decades. Further, the language explicitly prohibits any judicial review in either Federal or State court of the Secretary's decisions to grant immunity from lawsuits.

If anyone believes that the power is being exercised too broadly, or even in violation of the law, they apparently would have no remedy other than asking the Secretary to change his mind or asking Congress to amend the law.

Although proponents point to provisions of this language that make an exception and allow lawsuits in cases of willful misconduct, that exception is so narrowly drawn as to be almost meaningless. First, the provision defines ``willful misconduct'' as acts taken intentionally to achieve a wrongful purpose, knowing there is no legal or factual justification, and in disregard of known or obvious great risk. Basically, Mr. Speaker, the only conduct that would permit a lawsuit under this definition is probably conduct so egregious as to be criminal in nature.

However, even this highly restrictive definition of ``willful misconduct'' doesn't seem to have been enough restriction on lawsuits to satisfy the authors of division E. They added yet another provision that allows the Secretary of HHS to promulgate regulations further narrowing the scope of actions that could give rise to a right to sue. Then there is yet another provision that says that if the conduct in question is regulated under the Food and Drug Act or Public Health Service Act, a lawsuit for willful misconduct can be brought only if the Federal Government has taken enforcement action against that conduct.

Finally, the language makes various changes to the normal rules of civil procedure to add further obstacles and difficulties in front of a potential plaintiff. In short, as a practical matter, there is virtually no right for anyone to sue about anything covered by a secretarial determination under this language.

In summary, the administration asked for some very broad liability protections for manufacturers and others involved with countermeasures against pandemic flu, and the administration's proposal was widely criticized as going too far. With division E of the Defense appropriations conference report, Congress would be providing even broader protection, potentially covering a wide range of drugs, vaccines, and devices far beyond what is needed to deal with flu. Further, this denial of the right to sue is more sweeping than provided in the case of childhood vaccines or in the case of smallpox vaccine. In the smallpox case, manufacturers were protected by basically substituting the Federal Government as defendant, with the scope of potential lawsuits against the Federal Government narrowed, but not eliminated.

Now, Mr. Speaker, I recognize that some sort of liability protection or indemnification is necessary and appropriate to encourage development and manufacture of some measures to deal with pandemic flu; and I would support such reasonable language, language that has been reviewed by a committee that knows what it is doing in a process that allows for public comments. But there are real doubts about whether it needs to be this broad. It is worth noting that Sanofi Pasteur, our only domestic flu vaccine manufacturer, has already signed contracts with the Federal Government to make avian flu vaccine and has already delivered some lots, rather than refusing to proceed until legislation like this is enacted. Similarly, Roche has been supplying Tamiflu for the national stockpile and actively seeking contracts to supply more.

The result of this legislative action was a provision in the pending bill that prevents anyone who is a victim of a faulty vaccine from being able to obtain compensation in the courts. It says, in effect, that if you become seriously ill because of mistakes in manufacturing that you lose your right to sue for compensation, but you can as an alternative seek compensation from the government. The problem is that no funds were provided, or no money was provided, for that fund. So anyone who gets sick would have to lobby Congress to put money in the fund before they can collect. Thus, people injured lose their right to sue, but are not guaranteed any alternative means of covering their medical bills, lost earnings, and other costs.

Mr. Speaker, the committee system was created years ago to ensure that, to protect the public interest, legislation would be carefully reviewed before it was placed before the body for consideration. But that protection was arbitrarily bypassed by the leadership in both Houses.

This is the second time that this Congress has supinely done the bidding of the pharmaceutical industry in the dead of night. The first time a vote was held open for 3 hours while the Republican majority twisted arms to create the complex and ridiculously confusing prescription drug bill that our seniors are now so desperately trying to understand, a bill that was ushered through this institution by over 600 lobbyists and that protected companies by preventing the government from even attempting to negotiate lower drug prices.

If I thought that denying unanimous consent on this bill would force the majority to eliminate that language, I would object. But, Mr. Speaker, it has also been made quite clear to me that the majority will not relent on the language that insulates drug companies. So, Mr. Speaker, I want it to be clear that the action to insert this special interest language in the bill is, in my view, a corruption of the legislative practices of the House.

When Congress returns in January, I intend to raise a question about the privileges of the House that are highlighted by this action because it has brought discredit to the House and should disturb every Member who serves here. No Member of Congress, no matter how powerful, should be able to unilaterally insist that provisions that were never discussed and never debated in the conference should wind up being slipped into that conference report without a vote of that same conference.

This is what happens when there are no checks and balances and when one party controls the White House, the Senate, and the House and respects no limits on its own use of power. We have been placed in this position because the House Republican leadership has sent Members home for the Christmas holidays with the message to the Senate that we would not be here even if the Senate changed the legislation the House sent. That was irresponsible, and the country will pay the price. This institution, unfortunately, will also pay a price in terms of diminished respect from the people we were elected to represent.

This is a shameful and shabby way to end the worst session of Congress I have experienced in my 36 years in this House. So, Mr. Speaker, I most reluctantly withdraw my reservation, because lodging an objection at this point would simply delay the shameful inevitable.

Mr. President, parliamentary inquiry.

If the Leader's unanimous consent request is granted, the bill is thus sent to the House. Will that bill violate rule XXVIII? I am talking about the conference report. Will that conference report violate rule XXVIII?

I am speaking of the ANWR provisions and Katrina provisions and avian flu provisions. Will they violate rule XXVIII?

I can't hear the Chair.

So if this consent is granted, rule XXVIII is violated by this conference report; is that correct? Is that my understanding?

How do I join it? I want an agreement that this bill violates rule XXVIII.

I suggest the absence of a quorum. I do suggest the absence of a quorum.

The PRESIDING OFFICER The clerk will call the roll.

There has been some confusion. Let me restate my parliamentary inquiry. If sections C and E are removed, would the conference report as thus constituted contain violations of rule

I can assure you there are many more.

Thank you very much.

Wait. I will be glad to make a point of order, if you wish me to do it. Just so I understand the ruling, parliamentary inquiry: Did the Chair just say there is no point of order against this bill?

I want to make sure I understand this. I would be pleased to make a point of order so the Chair will rule, if you want me to do it. We have an understanding that there are violations of rule XXVIII in this bill.

Thank you.

Mr. President, I want to make sure everyone understands what we have done. I worked 3 months of my life on this bill, primarily to find a way to help the people whom I saw in New Orleans. But this unanimous consent agreement strips sections C and D out of the bill. That section D allocated the funds that were to be received from the development of ANWR and the spectrum money that we expect to come into the Treasury in excess of what was estimated in the budget and earmarked it to a gulf recovery fund and earmarked it to the LIHEAP program under a different formula than the existing formula.

The net result is that those who are going to vote for the separate resolution--and I shall vote against it--will

be taking money from the first responders. Let me go through that. There was $3.1 billion for our first responders, for homeland security needs. We had $1 billion for our farmers and ranchers for farm conservation programs. The gulf coast recovery fund was estimated to have $5 billion in bonus bids and $40 billion in royalties over the total production years of ANWR. It would have committed 50 percent to Louisiana, 25 percent to Mississippi, 10 percent to Alabama, 10 percent to Texas, and 5 percent to Florida.

When we remove that, we do remove the $2 billion emergency spending for LIHEAP, and we remove the $3.1 billion for border security. That is money that was there. It was not funny money. It was money for this year.

So when you go back to New York, will you tell them why? That first responder money was $1,750,000,000 for the cities of New York, Los Angeles, San Francisco, Miami, Boston, Washington, DC, Chicago, Philadelphia, and Houston. I showed before the list of all the people who supported that.

In terms of the preparedness grants for avian flu response, and for evacuation routes, refugee feeding and housing in the event of another disaster: $1 billion. But above all, the $1.1 billion in 2006 money for border security for the Northern border and the Southern border, we were overwhelmed with support for that. By voting for this, you will take it out. You are taking out C and D. You are taking out all the funding.

Now, what does that mean? It means that next year when we get the budget they will pick up the estimates we were able to make. The money for ANWR will next year be, I believe, estimated--I am sure it will; I have a letter--at $10 billion. This year it was $5 billion. That $5 billion that was in the budget will not be available to Louisiana. It will not be available to the disaster area. The $10 billion we estimated in addition to the $10 billion that is already in the budget for spectrum auctions will take place in 2008 and 2009. Actually, the FCC believes it is going to be $28 billion. We had used $8 billion in addition to the $10 billion that is in the budget. That, next year, will also be estimated, and it will be used by the budget. So that money is not going to be available for these things that Senator Cantwell's resolution will deny.

Senator Cantwell has authored this resolution to take out of the bill all of this money that we worked so hard to find a way to justify. We took future revenues coming into the Treasury, held them in the Treasury and earmarked them for specific purposes when they would arrive. We were told to have every reason to expect that money would come in. And the House agreed with us and allowed two separate emergency things to take place. One was $1.1 billion for border security. The other was $2 billion for LIHEAP for those who are in States that are affected by the current formula. That is primarily the Midwestern States and Maine.

But I want the Senate to know the work we did in finding this money and finding a way to hold it in the Treasury, it will not be held any more. This amendment takes out of the bill sections C and D. That means next year you will not find money on this approach for the help for the disaster areas or to deal with LIHEAP or to deal with homeland security. And $3 billion was earmarked in that fund when the money came in. It was to go to homeland security. We earmarked it. No future budget could use it.

By taking C and D out, by voting for it--all of you--I am going to go to every one of your States, and I am going to tell them what you have done. You have taken away from homeland security the one source of revenue that was new revenue. It was money that should have been used for disaster. It should have been used for homeland security. And I am sure that the Senator from Washington will enjoy my visits to Washington because I am going to visit there often.

This was wrong. We should have kept sections C and D in this bill. This was something that we studied. We went with CBO. We talked to everyone possible. Everyone understood it in the House, what we did. The Senate refused to even look at it. I think most of you voted for it without even looking at it. California has lost its money for disasters in the future from that revenue source. It will have to find some way through the budget to compete with everybody else next year in a declining budget year. Because as the interest on the national debt goes up, there is less money to allocate for existing programs. I predict next year will be the toughest budget year in history.

But we took money from 2008, 2009, 2010, and we earmarked it. One thing you did not notice, we put in borrowing authority. In the event there is a disaster, the Secretary could go to Treasury and say: Mr. Secretary of Treasury, I exercise the borrowing authority and get that money right now. Did you know that? I bet half of you--none of you-- read the bill, none of you read the bill. But I am going to explain the bill to everyone in the country--the homeland security bill, the first responders, the interoperability part of it, the part of equipment for first responders.

The total amount of this bill has been destroyed by the Cantwell amendment. And I want to make sure everyone understands it. Emergency assistance for seniors and low-income Americans: That $2 billion was at a different theory, different formula than the existing law. We made it available to those in great need this winter. By this amendment, by voting for it, you take it away. Go ahead and vote for it. I am going to vote against it because I know what I did. I found and spent a lot of time with those who handle budget matters and particularly the CBO. Ask them. I will show you the letters. They said I was right, that was new revenue coming into the Federal Government. Everyone expects it, and we earmarked it for those things that we all believe in now.

Next year, are you going to give it to homeland security? Are you going to give it to border security? Are you going to give them $2 billion for LIHEAP? By the way, it did not have to be spent this year. It could carry over. It is to be used when needed, by higher prices. OK? It was not something that was total spending this year.

I do think the hurricane areas are the ones that lost most. There is a $14 billion estimate in C and D for the hurricane area: $7 billion for Louisiana, $3.5 billion for Mississippi, $1.4 billion for Texas, $1.4 billion for Alabama, and $1.2 billion for Florida.

Mr. President, this Senator has tried to do what is right. In the last month or 2 months, I have been pilloried by almost every newspaper in this country because of what has been said on this floor and what has been said by Members on the other side of this body. I have been called a liar. I have been told that I violated the rules. I have been told I did things in the middle of the night when no one knew it. I have been told almost everything. Even my grandchildren asked my son: Is that right?

I ask the Senate: Is that right? Should I lose the reputation I have gotten for 37 years in the Senate? No one has ever questioned my integrity before this year. Well, we had one little thing--I see an action from the Chair--about an ethics matter in my State, but that, too, was misunderstood. And I am glad to see that--I hope that has been put to rest. But in any event, no one has really questioned my actions here on the floor.

But they have been. People I have known on the other side, on a first-name basis, have come to me and talked to me about their problems--each one of you. Many of you have spoken here and said things that are not true, and you know they are not true. As I said, one Senator said something so bad, I asked for an apology. I would not accept his apology now.

Mr. President, I am going to go home, and I am going to think about this, and I am going to try to figure out what to do next year. But I know one thing, the 3 months I spent on this to try and help the people in the disaster area, with the sincere belief in the--how many of you have been to the disaster area? Did you spend a couple of days down there, as I did? Did you go and look at it? Did you see the miles and miles of homes that are gone? Did you see a great big barge, bigger than this room, on top of a schoolhouse? Did you see miles and miles of levees just laid down? Did you see the devastation as that tsunami came up that channel that man dug from New Orleans to the gulf?

Did you see that? Did you see how it devastated the land, and all the plant life is now dying because it was inundated in saltwater?

The earthquake in my State did that. I saw one town disappear. I saw a third of my city, Anchorage, disappear. You have to have had that experience to understand how I felt when I went to New Orleans.

You people didn't believe it. Many of you said I did this for political reasons, just a crass thing, pick up some money and give it away for votes. I never asked one of you for a vote. I talked to some of you about how you should vote, but I never went to you and said: You have to vote for me. You wouldn't be voting for me; it was voting for the people who would have been helped.

This has been the saddest day of my life. It is a day I don't want to remember, and I am sorry to see it come to an end. Because I am drawing the line now with a lot of people I have worked with before. I really am. I can't put in my mind the amount of time, the days I have spent with you working on your problems, and to know you said about me the things you said in the last 2 months. I say goodbye to the Senate tonight. Thank you very much.

Mr. Speaker, further reserving the right to object, last week as American soldiers continued to bravely wage the war on terror in Iraq and Afghanistan, the House of Representatives passed a Defense appropriations bill containing a nongermane provision, language that would open up the Arctic National Wildlife Refuge to exploration. The agreement to include ANWR in the Defense appropriation turned what was essentially a bipartisan bill into a fight on the floor of both legislative bodies,

placing at risk the timely funding of our troops. Defense appropriations bills are historically the most protected type of legislation considered by the United States Congress. The Defense bill is usually the first piece of appropriations legislation passed by the House and Senate, and its language is kept clean from unnecessary and nongermane add-ons and amendments. That is why the addition of ANWR was so surprising to so many Members.

Prior to the vote earlier this week, I wrote a letter to the Rules Committee chairman expressing in the strongest terms possible my opposition and disappointment at the decision to place ANWR in the bill before the House. Mr. Speaker, I was not alone in my concern. Prior to Senate debate on the House-approved Defense bill, a group of high- ranking officers, including General Anthony Zinni, United States Marine Corps, sent a letter stating their concern over ANWR's inclusion in the legislation.

They wrote, and I quote: ``With 160,000 troops fighting in Iraq, another 18,000 in Afghanistan and tens of thousands more around the world defending this country, Congress must finish its work and provide them the resources they need to do their job. We believe that any effort to attach controversial legislative language authorizing drilling in the Arctic National Wildlife Refuge to the Defense appropriations conference report will jeopardize Congress's ability to provide our troops and their families the resources they need in a timely fashion.''

They continued, saying that ``the passion and energy of the debate about drilling in ANWR is well known, and a testament to vibrant debate in our democracy. But it is not helpful to attach such a controversial nondefense legislative issue to a Defense appropriations bill. It only invites delay for our troops as Congress debates an important, but controversial, nondefense issue on a vital bill providing critical funding for our Nation's security.''

As I speak, our brave men and women in the Armed Forces are serving in every corner of the globe. The work our servicemen and -women do each day will create a safer world, a world where liberty and democracy will take root in regions of the world untouched by freedom and choice. Our military deserves our support and the best equipment, training, armament, and reward our government can offer them. That is why I am here today, to lend my strong support to the legislation. The Senate made the right choice yesterday to strip this bill of unnecessary ornaments. ANWR does not belong in the Defense bill, and I am proud to support the Senate version without it.

The Defense appropriation bill being considered by the House today is a good bill. It will enable our troops to stand down as Iraqi security forces stand up. This legislation provides $403.5 billion for our troops during this transition, equipping them with $8 billion to replace damaged equipment, $1.2 billion for force protection, and $500 million to train new security forces in Iraq and in Afghanistan. Also, this legislation provides an essential 3.1 percent military pay increase for our soldiers effective January 1, 2006. This legislation honors our military and is deserving of all of our support.

As good as this legislation is, Congress must remain vigilant in our responsibility to support our troops. The Associated Press recently ran an article questioning the amount of money needed to address emergency combat operations in Iraq and Afghanistan. The article reported that the military informally indicated to the House Armed Services Committee that they would need an additional 80 to $100 billion to fund operations in Iraq and Afghanistan. This request is made in addition to the $50 billion appropriated through the Defense bill. This request is still being drafted by the Department of Defense and will most likely come to the floor as an additional spending package after we return next year.

I call on my colleagues to support this additional funding when it arrives in the House. We cannot afford to leave our military unprotected and underfunded, especially at this important time in our Nation's history.

Next week, Mr. Speaker, I will travel to Iraq to see the progress the Iraqi security forces are making to take the fight to the insurgents and to take their nation's future into their own hands. I will also visit our troops to give them our thanks from a grateful Nation for the work that they are doing to fight the terrorists, to secure the nation and pave the way for a new and vibrant democracy in Iraq. Our troops must have a clear understanding that our support for them is unwavering. The American people must know that our support for our Armed Forces is strong. That is why this legislation must pass clean, devoid of any needless add-ons. I call on my colleagues to support the legislation and pass the Defense appropriation bill.

With that, Mr. Speaker, I withdraw my reservation of objection.