[Congressional Record Volume 151, Number 167 (Wednesday, December 21, 2005)]
[Senate]
[Pages S14233-S14240]
From the Congressional Record Online through the 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
[[Page S14234]]
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 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 be 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
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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 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:
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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
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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 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
[[Page S14238]]
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.
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
[[Page S14239]]
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?
[[Page S14240]]
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.
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.