[Congressional Record (Bound Edition), Volume 151 (2005), Part 22]
[Senate]
[Pages 30722-30729]
[From the U.S. Government Publishing Office, www.gpo.gov]




                 CORRECTING THE ENROLLMENT OF H.R. 2863

  Mr. FRIST. Mr. President, I ask unanimous consent that the Senate 
proceed to the concurrent resolution correcting the enrollment of H.R. 
2863 which is at the desk and was introduced by Senator Cantwell and 
relates to the conference report to accompany the Defense 
appropriations bill; I further ask consent that there be 30 minutes for 
debate equally divided between the two leaders or their designees; that 
no amendments or motions be in order, and that following that time the 
Senate proceed to a vote on the adoption of the resolution; I further 
ask that immediately following that vote the Senate proceed to a vote 
on the adoption of the conference report to accompany H.R. 2863; 
provided further that the cloture vote with respect to the Defense 
authorization be vitiated and the Senate proceed to an immediate vote 
on adoption of that conference report following the vote on the Defense 
appropriations measure; I further ask consent that once the House has 
agreed to the concurrent resolution without amendment, then the Labor-
HHS conference report be considered adopted; further that if the 
concurrent resolution that corrects the enrollment of the Defense bill 
is not agreed to tomorrow, then passage of the Defense appropriations 
bill is vitiated.
  Finally, I ask consent that if the House has not adopted the 
resolution, then, notwithstanding the adoption of the adjournment 
resolution, the Senate would reconvene Thursday, December 22, at 8 p.m.
  I further ask consent that following the above action, the Senate 
proceed to a bill at the desk relating to the extension of the PATRIOT 
Act, the bill be considered read three times and passed, and the motion 
to reconsider be laid on the table.
  Mr. STEVENS. Mr. President, parliamentary inquiry.
  The PRESIDING OFFICER. The Senator will state his inquiry.
  Mr. STEVENS. 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?
  The PRESIDING OFFICER. The Senator would have to specify a specific 
provision.
  Mr. STEVENS. I am speaking of the ANWR provisions and Katrina 
provisions and avian flu provisions. Will they violate rule XXVIII?
  The PRESIDING OFFICER. In the opinion of the Chair, those provisions 
violate rule XXVIII.
  Mr. STEVENS. I can't hear the Chair.
  The PRESIDING OFFICER. Those provisions do violate rule XXVIII.
  Mr. STEVENS. So if this consent is granted, rule XXVIII is violated 
by this conference report; is that correct? Is that my understanding?
  The PRESIDING OFFICER. That issue has not been clearly joined by this 
agreement.
  Mr. STEVENS. How do I join it? I want an agreement that this bill 
violates rule XXVIII.
  The PRESIDING OFFICER. The Senator would need to raise a point of 
order when the measure is pending.
  Mr. STEVENS. I suggest the absence of a quorum. I do suggest the 
absence of a quorum.
  The PRESIDING OFFICER The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. FRIST. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER (Mr. Chambliss). Without objection, it is so 
ordered.
  Mr. STEVENS. 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 
XXVIII?
  The PRESIDING OFFICER. The Chair is of the opinion that there

[[Page 30723]]

would be at least one violation of rule XXVIII.
  Mr. STEVENS. I can assure you there are many more.
  Thank you very much.
  Mr. LEVIN. Mr. President, parliamentary inquiry: Has the point of 
order been raised against any provision that would be left in this 
bill?
  The PRESIDING OFFICER. No, it hasn't.
  Mr. LEVIN. I thank the Chair.
  Mr. STEVENS. 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?
  The PRESIDING OFFICER. The majority leader is recognized.
  Mr. STEVENS. 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.
  Mr. REID. Yes, there are.
  Mr. STEVENS. Thank you.
  Mr. FRIST. Mr. President, I renew my unanimous consent request.
  Mr. KENNEDY. 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.
  The PRESIDING OFFICER. Is there objection?
  Mr. FRIST. Mr. President, I object.
  The PRESIDING OFFICER. There is objection.
  Is there objection to the unanimous consent request?
  Mrs. FEINSTEIN. Mr. President, reserving the right to object, it is 
my understanding--I ask that it be confirmed--that titles III and VII 
of the conference report to accompany H.R. 3122 concerning port 
security and the Combat Meth Act are not in this unanimous consent 
agreement. Is that correct?
  Mr. FRIST. Mr. President, that is correct.
  Mrs. FEINSTEIN. Mr. President, let me ask this question. The question 
is whether I can have such a commitment from the majority leader, since 
these are both bills that have passed this body unanimously and have 
also been conferenced by the House, if we could consider them when we 
come back in January to be the first order of business?
  Mr. FRIST. Mr. President, responding to the Senator from California, 
both of these issues--port security, as well as the methamphetamine--
are very important issues that I believe this body unanimously will 
support. And after consultation with the Democratic leader, we will 
address those very early when we come back in January or February. They 
are both very important bills.
  Mrs. FEINSTEIN. Does the minority leader concur in that?
  Mr. REID. Without reservation.
  Mrs. FEINSTEIN. Thank you. January or February. Thank you very much.
  The PRESIDING OFFICER. Is there objection to the unanimous consent?
  Without objection, it is so ordered.
  Mr. FRIST. Mr. President, real quickly, this means that we will have 
30 minutes of total debate followed by the concurrent resolution, 
followed immediately by Defense appropriations, followed by the 
authorization by voice. That is my understanding.
  Mr. LEVIN. Mr. President, reserving the right to object, I don't plan 
to, and I want to make sure no one needs a rollcall vote--I do not--on 
the authorization bill. I want to doublecheck with a few people on this 
side.
  Mr. FRIST. We already have unanimous consent, and I believe we will 
do that.
  Mr. LEAHY. Mr. President, might I direct a question to the 
distinguished majority leader through the Chair?
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. LEAHY. Mr. President, if I could have the attention of the 
majority leader, am I correct in my understanding that the Sununu-Leahy 
et al 6-month extension of the PATRIOT Act has been included? And that 
is where we are with the conference report still on the calendar, but 
the 6 months will be passed?
  Mr. FRIST. Mr. President, as part of the unanimous consent is the 6-
month extension on the PATRIOT Act.
  Mr. LEAHY. Sununu-Leahy et al. Thank you. I thank the Chair. I thank 
the two distinguished leaders.
  If I might note for a moment, both the distinguished Republican 
leader and the Democratic leader have worked extremely hard on this, as 
has the Senator from New Hampshire, Mr. Sununu, and Mr. Gregg and 
others, and, of course, the distinguished chairman of the committee, 
Senator Specter.
  I think this is a reasonable conclusion that will allow the Judiciary 
Committee to look at some of the questions which have legitimately been 
raised and would not have been heard had this gone through otherwise.
  Mr. REID. Mr. President, I yield 15 minutes to Senator Kennedy.
  The PRESIDING OFFICER. The clerk will report the concurrent 
resolution.
  The bill clerk read as follows:

       A concurrent resolution (S. Con. Res. 74) correcting the 
     enrollment of H.R. 2863.

  The Senate proceeded to consider the concurrent resolution.
  The PRESIDING OFFICER. Who yields time?
  Mr. REID. Mr. President, I yield 15 minutes to the Senator from 
Massachusetts.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. 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

[[Page 30724]]

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

[[Page 30725]]

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. HATCH. 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

[[Page 30726]]

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

[[Page 30727]]

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.
  The PRESIDING OFFICER (Mr. Voinovich). Who yields time?
  The Senator From Alaska.
  Mr. STEVENS. 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

[[Page 30728]]

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.
  The PRESIDING OFFICER. Who yields time?
  Mr. REID. I yield back the time on this side.
  Mr. FRIST. I yield back the time on our side.
  The PRESIDING OFFICER. The question is on agreeing to the concurrent 
resolution, S. Con. Res. 74.
  Mr. REID. I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The clerk will call the roll.
  The bill clerk called the roll.

[[Page 30729]]


  Mr. McCONNELL. The following Senators were necessarily absent: the 
Senator from South Carolina (Mr. DeMint), the Senator from New 
Hampshire (Mr. Gregg), the Senator from Arizona (Mr. McCain), and the 
Senator from Rhode Island (Mr. Chafee).
  Further, if present and voting, the Senator from South Carolina (Mr. 
DeMint) would have voted ``nay.''
  Mr. DURBIN. I announce that the Senator from New Jersey (Mr. 
Corzine), the Senator from Connecticut (Mr. Dodd), and the Senator from 
Indiana (Mr. Harkin) are necessarily absent.
  The PRESIDING OFFICER (Mr. Burr). Are there any other Senators in the 
Chamber desiring to vote?
  The result was announced--yeas 48, nays 45, as follows:

                      [Rollcall Vote No. 365 Leg.]

                                YEAS--48

     Akaka
     Baucus
     Bayh
     Biden
     Bingaman
     Boxer
     Byrd
     Cantwell
     Carper
     Clinton
     Coleman
     Collins
     Conrad
     Dayton
     DeWine
     Dorgan
     Durbin
     Feingold
     Feinstein
     Inouye
     Jeffords
     Johnson
     Kennedy
     Kerry
     Kohl
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Lugar
     Mikulski
     Murray
     Nelson (FL)
     Nelson (NE)
     Obama
     Pryor
     Reed
     Reid
     Rockefeller
     Salazar
     Sarbanes
     Schumer
     Smith
     Snowe
     Specter
     Stabenow
     Wyden

                                NAYS--45

     Alexander
     Allard
     Allen
     Bennett
     Bond
     Brownback
     Bunning
     Burns
     Burr
     Chambliss
     Coburn
     Cochran
     Cornyn
     Craig
     Crapo
     Dole
     Domenici
     Ensign
     Enzi
     Frist
     Graham
     Grassley
     Hagel
     Hatch
     Hutchison
     Inhofe
     Isakson
     Kyl
     Landrieu
     Lott
     Martinez
     McConnell
     Murkowski
     Roberts
     Santorum
     Sessions
     Shelby
     Stevens
     Sununu
     Talent
     Thomas
     Thune
     Vitter
     Voinovich
     Warner

                             NOT VOTING--7

     Chafee
     Corzine
     DeMint
     Dodd
     Gregg
     Harkin
     McCain
  The concurrent resolution (S. Con. Res. 74) was agreed to, as 
follows:

                            S. Con. Res. 74

       Resolved in the Senate (the House of Representatives 
     Concurring), That, in the enrollment of the bill (H.R. 2863) 
     making appropriations for the Department of Defense for the 
     fiscal year ending September 30, 2006, and for other 
     purposes, the Clerk of the House of Representatives shall 
     make the following corrections:
       Strike Division C, the American Energy Independence and 
     Security Act of 2005 and Division D, the Distribution of 
     Revenues and Disaster Assistance.

  Mrs. BOXER. I move to reconsider the vote.
  Mrs. FEINSTEIN. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.

                          ____________________