[Congressional Record Volume 152, Number 19 (Wednesday, February 15, 2006)]
[Senate]
[Pages S1360-S1363]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KENNEDY (for himself, Mr. Dodd, Mr. Harkin, and Mr. 
        Bingaman):
  S. 2291. A bill to provide for the establishment of a biodefense 
injury compensation program and to provide indemnification for 
producers of countermeasures; to the Committee on Health, Education, 
Labor, and Pensions.
  Mr. DODD. Mr. President, I rise today to join Senator Kennedy in 
introducing a bill, the Responsible Public Readiness and Emergency 
Preparedness Act, that will correct a grievous mistake made by some of 
my Republican colleagues. Our legislation will take responsible steps 
to protect the American people from one of the greatest threats facing 
our nation--a pandemic flu, bioterror attack or infectious disease 
outbreak.
  Congress should have no higher priority than protecting the safety, 
security, and health of the American people. Public health experts have 
warned that a severe avian flu epidemic could lead to worldwide panic, 
cost millions of lives, and result in untold economic damage.
  In order to prevent these dire projections from becoming a reality, 
we have no choice but to be prepared for such an event. One of the 
indispensable components of a biodefense plan is the availability of 
safe and effective vaccines and medicines. To achieve this goal, a 
biodefense plan must have two critical components. First, it must 
encourage drug companies to develop and manufacture effective medicines 
to counteract a disease or flu. Second, it must encourage first 
responders, health care workers, and ordinary citizens to take those 
medicines before, during, or after an attack or outbreak.
  In December of last year, some of my Republican colleagues inserted 
language that contained neither of these critical components into the 
Department of Defense Appropriations conference report. This was done 
at the last minute, in the middle of the night, without the opportunity 
for discussion and debate, and without the knowledge or consent of many 
of the conferees.
  Unfortunately, this Republican plan will do nothing to protect the 
American people. Rather than encouraging companies to make safe and 
effective medicines, it will provide a perverse incentive by protecting 
those companies that make ineffective or harmful products. And rather 
than encouraging Americans to be vaccinated or take a needed 
medication, it will discourage them from doing so by failing to provide 
guaranteed care for the few who will inevitably be injured by these 
products. Make no mistake about it; this plan will fail to protect our 
Nation.
  I say this with confidence because we have been down this path 
before. Three years ago, the Bush administration launched a program to 
inoculate millions of first responders against smallpox. Ignoring 
public health experts, the administration failed to establish a 
compensation program to provide help to those injured by the vaccine. 
Doctors, nurses, firefighters and other first responders who would be 
on the front lines in the event of a smallpox attack by terrorists were 
not willing to roll the dice and risk the future of their families 
without compensation for their losses if they were injured, disabled, 
or even killed by its side effects. Most refused to participate, and 
the program was a failure.
  On November 9 of last year, while testifying before the Senate 
Foreign Relations Committee, Dr. Julie Gerberding, the Director of the 
Centers for Disease Control and Prevention (CDC), was asked about the 
expected success of a biodefense plan that does not include fair 
compensation to people injured by the very medicines they thought would 
help them. She responded: ``Well, I certainly feel that from the 
standpoint of the smallpox vaccination program, that the absence of a 
compensation program that was acceptable to the people we were hoping 
to vaccinate was a major barrier--and I think we've learned some 
lessons from that.''
  On November 20 of last year, while appearing on NBC's Meet the Press, 
Secretary of Health and Human Services Mike Leavitt said that along 
with limits on liability, ``adequate compensation . . . needs to be 
made for those who are hurt.''
  Many groups representing the public health community and first 
responders, including the American Public Health Association, the 
American Nurses Association, and the American Federation of State, 
County, and Municipal Employees, have been outspoken about the need for 
a compensation program.
  Yet despite our past experience, despite the position taken by those 
at high levels in the administration, and despite the warnings of those 
who would be on the front lines in the event of an outbreak, the 
Republican leadership in Congress included language in

[[Page S1361]]

the Defense Appropriations conference report that repeats the mistakes 
of the past, and endangers American lives. If and when we have a 
vaccine to protect against a pandemic flu, we must provide first 
responders with a reasonable assurance that it will be as safe as can 
reasonably be expected, and that they and their families will be taken 
care of should they be injured. This plan does not provide that 
assurance, and once again, first responders will refuse to participate.

  Those who inserted this provision into the Conference Report during 
late night backroom negotiations claim that it includes compensation. 
But make no mistake--there is no guaranteed compensation in this bill. 
There is a provision to set up a compensation fund, but there is 
absolutely no guarantee that this fund will ever see a penny. The 
authors of this provision are claiming to take care of the injured, 
without providing any guarantee that it will ever happen. They are 
making an empty promise.
  Not only will this plan fail to compensate those first responders and 
ordinary citizens injured or even killed by a vaccine, but it will also 
protect manufacturers even when they act with disregard for the safety 
of their products. This is an incredibly dangerous and inappropriate 
incentive. We should be encouraging manufacturers to make safe 
products, not protecting them when they make products that harm the 
American people.
  Let me make it perfectly clear that I am not against the idea of 
providing limited liability protection for manufacturers in order to 
encourage the development of vaccines and medicines to protect the 
American people in the event of an outbreak or bioterror attack. But 
such liability protection must adhere to certain principles. First, it 
must not protect manufacturers that act with careless disregard for the 
safety and effectiveness of their product. And second, because even the 
safest vaccine will harm a small percentage of the people who take it, 
liability protection must be coupled with an adequate compensation 
program so that injured patients are properly cared for and not left 
destitute.
  The legislation that Senator Kennedy and I are introducing today 
adheres to these principles. It repeals the Republican provision passed 
in December, and replaces it with tried-and-true solutions that will 
encourage the production of vaccines and drugs without leaving patients 
to fend for themselves if they are injured. Our legislation will ensure 
that the reputable and responsible manufacturers of needed medicines--
and the doctors, nurses, and hospitals who administer them in good 
faith--will be protected from frivolous lawsuits that might deter them 
from making and administering such medicines. But those injured by 
these medicines will be justly compensated for their injuries.
  Congress has adopted this type of solution in the past. The 
compensation program established by our bill is modeled on one of those 
past successes--the Vaccine Injury Compensation Program (VICP). The 
VICP has successfully incentivized the manufacturers of recommended 
childhood vaccines, encouraged families to have their children 
vaccinated, and compensated those who are injured.
  Senator Kennedy and I spent several months last year negotiating with 
Senator Enzi, Senator Burr, Senator Gregg, Senator Frist, and others on 
the Health, Education, Labor, and Pensions Committee to try to reach a 
bipartisan compromise on this issue. We made several proposals, modeled 
on past Congressional action, to protect manufacturers from frivolous 
lawsuits while providing fair and adequate compensation to those who 
are injured.
  Unfortunately, the decision was made to forego this bipartisan 
process. Instead, a non-germane provision was inserted into a massive 
appropriations bill in the final hours of last session of Congress. 
Furthermore, it is my understanding that this language was inserted 
after members had signed the Conference Report, some doing so with the 
understanding that this language was not included. I am disturbed and 
disappointed by this blatant abuse of power and disregard for Senate 
procedures. I can only assume that the supporters of this provision 
used this tactic because they knew that their plan would not stand up 
to public scrutiny and Senate debate.
  I am confident that if the Senate were to consider this issue 
carefully, we would choose to reject the failed policies of the past, 
and enact a policy that really protects the American people--a 
biodefense program that encourages manufacturers to make safe and 
effective vaccines and medicines, and provides compensation to those 
individuals who are injured by those vaccines and medicines.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2291

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE,

       This Act may be cited as the ``Responsible Public Readiness 
     and Emergency Preparedness Act''.

     SEC. 2. REPEAL.

       The Public Readiness and Emergency Preparedness Act 
     (division C of the Department of Defense, Emergency 
     Supplemental Appropriations to Address Hurricanes in the Gulf 
     of Mexico, and Pandemic Influenza Act, 2006 (Public Law 109-
     148)) is repealed.

     SEC. 3. NATIONAL BIODEFENSE INJURY COMPENSATION PROGRAM.

       (a) Establishment.--Section 224 of the Public Health 
     Service Act (42 U.S.C. 233) is amended by adding at the end 
     the following:
       ``(q) Biodefense Injury Compensation Program.--
       ``(1) Establishment.--There is established the Biodefense 
     Injury Compensation Program (referred to in this subsection 
     as the `Compensation Program') under which compensation may 
     be paid for death or any injury, illness, disability, or 
     condition that is likely (based on best available evidence) 
     to have been caused by the administration of a covered 
     countermeasure to an individual pursuant to a declaration 
     under subsection (p)(2).
       ``(2) Administration and interpretation.--The statutory 
     provisions governing the Compensation Program shall be 
     administered and interpreted in consideration of the program 
     goals described in paragraph (4)(B)(iii).
       ``(3) Procedures and standards.--The Secretary shall by 
     regulation establish procedures and standards applicable to 
     the Compensation Program that follow the procedures and 
     standards applicable under the National Vaccine Injury 
     Compensation Program established under section 2110, except 
     that the regulations promulgated under this paragraph shall 
     permit a person claiming injury or death related to the 
     administration of any covered countermeasure to file either--
       ``(A) a civil action for relief under subsection (p); or
       ``(B) a petition for compensation under this subsection.
       ``(4) Injury table.--
       ``(A) Inclusion.--For purposes of receiving compensation 
     under the Compensation Program with respect to a 
     countermeasure that is the subject of a declaration under 
     subsection (p)(2), the Vaccine Injury Table under section 
     2114 shall be deemed to include death and the injuries, 
     disabilities, illnesses, and conditions specified by the 
     Secretary under subparagraph (B)(ii).
       ``(B) Injuries, disabilities, illnesses, and conditions.--
       ``(i) Institute of medicine.--Not later than 30 days after 
     making a declaration described in subsection (p)(2), the 
     Secretary shall enter into a contract with the Institute of 
     Medicine, under which the Institute shall, within 180 days of 
     the date on which the contract is entered into, and 
     periodically thereafter as new information, including 
     information derived from the monitoring of those who were 
     administered the countermeasure, becomes available, provide 
     its expert recommendations on the injuries, disabilities, 
     illnesses, and conditions whose occurrence in one or more 
     individuals are likely (based on best available evidence) to 
     have been caused by the administration of a countermeasure 
     that is the subject of the declaration.
       ``(ii) Specification by secretary.--Not later than 30 days 
     after the receipt of the expert recommendations described in 
     clause (i), the Secretary shall, based on such 
     recommendations, specify those injuries, disabilities, 
     illnesses, and conditions deemed to be included in the 
     Vaccine Injury Table under section 2114 for the purposes 
     described in subparagraph (A).
       ``(iii) Program goals.--The Institute of Medicine, under 
     the contract under clause (i), shall make such 
     recommendations, the Secretary shall specify, under clause 
     (ii), such injuries, disabilities, illnesses, and conditions, 
     and claims under the Compensation Program under this 
     subsection shall be processed and decided taking into account 
     the following goals of such program:

       ``(I) To encourage persons to develop, manufacture, and 
     distribute countermeasures, and to administer covered 
     countermeasures to individuals, by limiting such persons' 
     liability for damages related to death and such injuries, 
     disabilities, illnesses, and conditions.

[[Page S1362]]

       ``(II) To encourage individuals to consent to the 
     administration of a covered countermeasure by providing 
     adequate and just compensation for damages related to death 
     and such injuries, disabilities, illnesses, or conditions.
       ``(III) To provide individuals seeking compensation for 
     damages related to the administration of a countermeasure 
     with a non-adversarial administrative process for obtaining 
     adequate and just compensation.

       ``(iv) Use of best available evidence.--The Institute of 
     Medicine, under the contract under clause (i), shall make 
     such recommendations, the Secretary shall specify, under 
     clause (ii), such injuries, disabilities, illnesses, and 
     conditions, and claims under the Compensation Program under 
     this subsection shall be processed and decided using the best 
     available evidence, including information from adverse event 
     reporting or other monitoring of those individuals who were 
     administered the countermeasure, whether evidence from 
     clinical trials or other scientific studies in humans is 
     available.
       ``(v) Application of section 2115.--With respect to section 
     2115(a)(2) as applied for purposes of this subsection, an 
     award for the estate of the deceased shall be--

       ``(I) if the deceased was under the age of 18, an amount 
     equal to the amount that may be paid to a survivor or 
     survivors as death benefits under the Public Safety Officers' 
     Benefits Program under subpart 1 of part L of title I of the 
     Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 
     3796 et seq.); or
       ``(II) if the deceased was 18 years of age or older, the 
     greater of--

       ``(aa) the amount described in subclause (I); or
       ``(bb) the projected loss of employment income, except that 
     the amount under this item may not exceed an amount equal to 
     400 percent of the amount that applies under item (aa).
       ``(vi) Application of section 2116.--Section 2116(b) shall 
     apply to injuries, disabilities, illnesses, and conditions 
     initially specified or revised by the Secretary under clause 
     (ii), except that the exceptions contained in paragraphs (1) 
     and (2) of such section shall not apply.
       ``(C) Rule of construction.--Section 13632 (a)(3) of Public 
     Law 103-66 (107 Stat. 646) (making revisions by Secretary to 
     the Vaccine Injury Table effective on the effective date of a 
     corresponding tax) shall not be construed to apply to any 
     revision to the Vaccine Injury Table made under regulations 
     under this paragraph.
       ``(5) Application.--The Compensation Program applies to any 
     death or injury, illness, disability, or condition that is 
     likely (based on best available evidence) to have been caused 
     by the administration of a covered countermeasure to an 
     individual pursuant to a declaration under subsection (p)(2).
       ``(6) Special masters.--
       ``(A) Hiring.--In accordance with section 2112, the judges 
     of the United States Claims Court shall appoint a sufficient 
     number of special masters to address claims for compensation 
     under this subsection.
       ``(B) Budget authority.--There are appropriated to carry 
     out this subsection such sums as may be necessary for fiscal 
     year 2006 and each fiscal year thereafter. This subparagraph 
     constitutes budget authority in advance of appropriations and 
     represents the obligation of the Federal Government.
       ``(7) Covered countermeasure.--For purposes of this 
     subsection, the term `covered countermeasure' has the meaning 
     given to such term in subsection (p)(7)(A).
       ``(8) Funding.--Compensation made under the Compensation 
     Program shall be made from the same source of funds as 
     payments made under subsection (p).''.
       (b) Effective Date.--This section shall take effect as of 
     November 25, 2002 (the date of enactment of the Homeland 
     Security Act of 2002 (Pub. L. 107-296; 116 Stat. 2135)).

     SEC. 4. INDEMNIFICATION FOR MANUFACTURERS AND HEALTH CARE 
                   PROFESSIONALS WHO ADMINISTER MEDICAL PRODUCTS 
                   NEEDED FOR BIODEFENSE.

       Section 224(p) of the Public Health Service Act (42 U.S.C. 
     233(p)) is amended--
       (1) in the subsection heading by striking ``Smallpox'';
       (2) in paragraph (1), by striking ``against smallpox'';
       (3) in paragraph (2)--
       (A) in the paragraph heading, by striking ``against 
     smallpox''; and
       (B) in subparagraph (B), by striking clause (ii);
       (4) by striking paragraph (3) and inserting the following:
       ``(3) Exclusivity; offset.--
       ``(A) Exclusivity.--With respect to an individual to which 
     this subsection applies, such individual may bring a claim 
     for relief under--
       ``(i) this subsection;
       ``(ii) subsection (q); or
       ``(iii) part C.
       ``(B) Election of alternatives.--An individual may only 
     pursue one remedy under subparagraph (A) at any one time 
     based on the same incident or series of incidents. An 
     individual who elects to pursue the remedy under subsection 
     (q) or part C may decline any compensation awarded with 
     respect to such remedy and subsequently pursue the remedy 
     provided for under this subsection. An individual who elects 
     to pursue the remedy provided for under this subsection may 
     not subsequently pursue the remedy provided for under 
     subsection (q) or part C.
       ``(C) Statute of limitations.--For purposes of determining 
     how much time has lapsed when applying statute of limitations 
     requirements relating to remedies under subparagraph (A), any 
     limitation of time for commencing an action, or filing an 
     application, petition, or claim for such remedies, shall be 
     deemed to have been suspended for the periods during which an 
     individual pursues a remedy under such subparagraph.
       ``(D) Offset.--The value of all compensation and benefits 
     provided under subsection (q) or part C of this title for an 
     incident or series of incidents shall be offset against the 
     amount of an award, compromise, or settlement of money 
     damages in a claim or suit under this subsection based on the 
     same incident or series of incidents.'';
       (5) in paragraph (6)--
       (A) in subparagraph (A), by inserting ``or under subsection 
     (q) or part C'' after ``under this subsection''; and
       (B) by redesignating subparagraph (B) as subparagraph (C);
       (C) by inserting after subparagraph (A), the following:
       ``(B) Grossly negligent, reckless, or illegal conduct and 
     willful misconduct.--For purposes of subparagraph (A), 
     grossly negligent, reckless, or illegal conduct or willful 
     misconduct shall include the administration by a qualified 
     person of a covered countermeasure to an individual who was 
     not within a category of individuals covered by a declaration 
     under subsection (p)(2) with respect to such countermeasure 
     where the qualified person fails to have had reasonable 
     grounds to believe such individual was within such a 
     category.''; and
       (D) by adding at the end the following:
       ``(D) Liability of the united states.--The United States 
     shall be liable under this subsection with respect to a claim 
     arising out of the manufacture, distribution, or 
     administration of a covered countermeasure regardless of 
     whether--
       ``(i) the cause of action seeking compensation is alleged 
     as negligence, strict liability, breach of warranty, failure 
     to warn, or other action; or
       ``(ii) the covered countermeasure is designated as a 
     qualified anti-terrorism technology under the SAFETY Act (6 
     U.S.C. 441 et seq.).
       ``(E) Governing law.--Notwithstanding the provisions of 
     section 1346(b)(1) and chapter 171 of title 28, United States 
     Code, as they relate to governing law, the liability of the 
     United States as provided in this subsection shall be in 
     accordance with the law of the place of injury.
       ``(F) Military personnel and united states citizens 
     overseas.--
       ``(i) Military personnel.--The liability of the United 
     States as provided in this subsection shall extend to claims 
     brought by United States military personnel.
       ``(ii) Claims arising in a foreign country.--
     Notwithstanding the provisions of section 2680(k) of title 
     28, United States Code, the liability of the United States as 
     provided for in the subsection shall extend to claims based 
     on injuries arising in a foreign country where the injured 
     party is a member of the United States military, is the 
     spouse or child of a member of the United States military, or 
     is a United States citizen.
       ``(iii) Governing law.--With regard to all claims brought 
     under clause (ii), and notwithstanding the provisions of 
     section 1346(b)(1) and chapter 171 of title 28, United States 
     Code, and of subparagraph (C), as they relate to governing 
     law, the liability of the United States as provided in this 
     subsection shall be in accordance with the law of the 
     claimant's domicile in the United States or most recent 
     domicile with the United States.''; and
       (6) in paragraph (7)--
       (A) by striking subparagraph (A) and inserting the 
     following:
       ``(A) Covered countermeasure.--The term `covered 
     countermeasure', means--
       ``(i) a substance that is--

       ``(I)(aa) used to prevent or treat smallpox (including the 
     vaccinia or another vaccine); or
       ``(bb) vaccinia immune globulin used to control or treat 
     the adverse effects of vaccinia inoculation; and
       ``(II) specified in a declaration under paragraph (2); or

       ``(ii) a drug (as such term is defined in section 201(g)(1) 
     of the Federal Food, Drug, and Cosmetic Act), biological 
     product (as such term is defined in section 351(i) of this 
     Act), or device (as such term is defined in section 201(h) of 
     the Federal Food, Drug, and Cosmetic Act) that--

       ``(I) the Secretary determines to be a priority (consistent 
     with sections 302(2) and 304(a) of the Homeland Security Act 
     of 2002) to treat, identify, or prevent harm from any 
     biological, chemical, radiological, or nuclear agent 
     identified as a material threat under section 319F-
     2(c)(2)(A)(ii), or to treat, identify, or prevent harm from a 
     condition that may result in adverse health consequences or 
     death and may be caused by administering a drug, biological 
     product, or device against such an agent;
       ``(II) is--

       ``(aa) authorized for emergency use under section 564 of 
     the Federal Food, Drug, and Cosmetic Act, so long as the 
     manufacturer of such drug, biological product, or device 
     has--
       ``(AA) made all reasonable efforts to obtain applicable 
     approval, clearance, or licensure; and
       ``(BB) cooperated fully with the requirements of the 
     Secretary under such section 564; or

[[Page S1363]]

       ``(bb) approved or licensed solely pursuant to the 
     regulations under subpart I of part 314 or under subpart H of 
     part 601 of title 21, Code of Federal Regulations (as in 
     effect on the date of enactment of the National Biodefense 
     Act of 2005); and

       ``(III) is specified in a declaration under paragraph 
     (2).''; and

       (B) in subparagraph (B)--
       (i) by striking clause (ii), and inserting the following:
       ``(ii) a health care entity, a State, or a political 
     subdivision of a State under whose auspices such 
     countermeasure was administered;'' and
       (vi) in clause (viii), by inserting before the period ``if 
     such individual performs a function for which a person 
     described in clause (i), (ii), or (iv) is a covered person''.
                                 ______