[Congressional Record Volume 148, Number 34 (Thursday, March 21, 2002)]
[Senate]
[Pages S2276-S2281]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. FRIST:
  S. 2053. A bill to amend the Public Health Service Act to improve 
immunization rates by increasing the distribution of vaccines and 
improving and clarifying the vaccine injury compensation program, and 
for other purposes; to the Committee on Health, Education, Labor, and 
Pensions.
  Mr. FRIST. Mr. President, I rise today to introduce the ``Vaccine 
Affordability and Availability Act.'' The United States has succeeded 
in dramatically reducing the incidence of disease through the use of 
vaccines. In some cases, we've even been able to eradicate specific 
diseases, including smallpox. Smallpox, which has killed more people 
than any other disease or war in history, has been eradicated by the 
research, development and deployment of vaccines.
  Still, our success should not and must not dampen our resolve for 
combating disease with vaccines. Many vaccine-preventable diseases are 
still increasing morbidity and mortality due to a lack of public 
awareness about the existence and effectiveness of vaccines, and, in 
some cases, due to a shortage of certain vaccines.
  The goal of this bill is to improve how we vaccinate people in 
America today. It would reduce the cost of vaccines, make vaccines more 
accessible,

[[Page S2277]]

enhance vaccine education, and streamline the vaccine compensation 
program. I urge all of my colleagues, on both sides of the aisle, to 
support this bill and, in so doing, support the prevention of disease 
and the saving of lives.
  We must strengthen our immunization system. We need only look at the 
experiences of three developed countries, Great Britain, Sweden and 
Japan, when they allowed their immunization rates to drop due to fear 
associated with the pertussis, whooping cough, vaccine. In Great 
Britain, a decrease in pertussis immunizations in 1974 resulted in an 
epidemic of more than 100,000 cases of pertussis and 36 deaths by 1978. 
In Japan between 1974 and 1979, pertussis vaccination rates fell from 
70 percent, with 393 cases and no deaths, to around 20 to 40 percent, 
with 13,000 cases and 41 deaths. In Sweden between 1981 and 1985, the 
annual incidence rate of pertussis per 100,000 children 0-6 years of 
age increased from 700 cases to 3,200 cases. Low diphtheria 
immunization rates in the former Soviet Union for children and the lack 
of booster immunizations for adults have increased diphtheria from 839 
cases in 1989 to nearly 50,000 cases and 1,700 deaths in 1994.
  As the General Accounting Office, GAO, described in a March 2000 
report, infectious diseases are responsible for nearly half of all 
deaths worldwide for people under the age of 44. The report further 
states that immunizing children against infectious diseases is 
``considered to be one of the most effective public health initiatives 
ever undertaken'' in the United States and the number of people in the 
United States contracting vaccine-preventable diseases has been reduced 
by more than 95 percent. Every year, millions of children are safely 
vaccinated, preventing thousands of childhood deaths and even more 
debilitating illnesses. While vaccines save lives and save the nation 
from lifelong medical costs associated with contracting vaccine-
preventable diseases, no product is risk-free.
  When Congress passed the National Childhood Vaccine Injury Act in 
1986, it recognized that ``[v]accination of children against deadly, 
disabling, but preventable infectious diseases has been one of the most 
spectacularly effective public health initiatives this country has ever 
undertaken.'' Congress further noted that the ``[u]se of vaccines has 
prevented thousands of children's deaths each year and has 
substantially reduced the effects resulting from disease.'' Congress 
further recognized that the cost of litigation initiated on behalf of 
children claiming vaccine-related injuries has resulted in an enormous 
increase in the price of vaccines and a significant reduction in the 
number of vaccine manufacturers in the U.S. market.
  The Advisory Commission on Childhood Vaccines, ACCV, was established 
pursuant to the 1986 National Childhood Vaccine Injury Act to advise 
the Secretary of HHS on ways to improve the Vaccine Injury Compensation 
Program, which was also established in the same law. Meeting minutes 
from a September 2001 ACCV meeting best sum up the integral connection 
between vaccine supply, production, and liability concerns that our 
bill seeks to address: ``The vaccine supply in the United States is 
becoming quite fragile. Over the last 20 to 30 years, there has been a 
significant decrease in the number of vaccine manufacturers. As a 
result, there is a relatively small group of manufacturers with limited 
manufacturing capability. This fragility compromises the ability to 
meet current vaccine needs and limits capacity to respond to 
emergencies.''
  In the early 1980s, lawsuits alleging vaccine-related injury or death 
threatened vaccine production, availability, cost and even the 
development of new vaccines. Coupled with already low profit margins, 
the vaccine market became unstable. Gross sales of the DTP vaccine in 
1980 for all manufacturers fell to about $3 million. If even a few of 
the vaccinated children experienced adverse reactions to the DTP 
vaccine and recovered $1 million each, for a lifetime of mental 
impairment, then damages would easily exceed total sales. Costs 
associated with researching new vaccines and the uncertainty created by 
liability once the vaccine was approved by the Food and Drug 
Administration and marketed, further jeopardized future vaccine 
development.
  In an attempt to address liability projections, manufacturers either 
raised their prices, the DTP vaccine rose from $.19 in 1980 to more 
than $12.00 by 1986, or left the vaccine market entirely. By the mid-
1980's, the number of manufacturers of DTP vaccine declined from seven 
to one and the Nation experienced a critical shortage of vaccine. As a 
result, we stopped immunizing 2 year olds, leaving them vulnerable to 
whooping cough, diphtheria, and tetanus.
  In 1986, Congress established the Vaccine Injury Compensation 
Program, VICP, as part of the National Childhood Vaccine Injury Act. 
The VICP was created to address two major goals: To provide 
compensation to those who suffered rare but serious side effects from 
vaccines and to stabilize the vaccine production and supply market. The 
VICP was established as a Federal ``no-fault'' compensation system to 
compensate individuals who have been injured by certain covered 
childhood vaccines. While vaccine-injured parties are required to file 
claims under the VICP before filing lawsuits, proof requirements are 
much lower than in court and procedures are simplified for injuries 
that are listed on the Vaccine Injury Table. The balance that was 
struck was that the burden of proving causation was significantly 
reduced for VICP claimants, while the litigation burden on 
manufacturers and administrators of covered vaccines is decreased.
  The Vaccine Affordability and Availability Act seeks to ensure the 
VICP balance between fairness to claimants seeking compensation for 
vaccine-related injury or death and stability for continued vaccine 
production is strengthened. It further addresses the concerns of 
claimants who file for compensation under VICP, in large part based on 
recommendations made by the Advisory Commission on Childhood Vaccines, 
ACCV. Because family plays such an important role in the rehabilitation 
and treatment of a child injured by a vaccine, the legislation allows 
VICP awards to cover family counseling and guardianship costs.

  Additionally, the bill raises the payment ceiling on two capped 
payments that have not been raised since the VICP was implemented in 
1988. The legislation also lengthens the filing deadline so that 
petitioners may have more time to adequately assess the life care and 
medical needs of a vaccine-injured child before filing and adjudicating 
a VICP claim. It also allows claimants to recover interim costs before 
final judgment is reached, to ease the financial strain on petitioners 
for costs associated with filing a VICP claim. The bill also broadened 
the membership criteria so that an adult who has been injured by a 
vaccine may participate on the ACCV. Finally, the legislation makes 
clear that all of these changes apply to pending and future VICP 
claims.
  Today, only two American companies and two European companies sell 
vaccines in the United States. The United States is currently 
experiencing shortages in 5 of the 9 recommended childhood vaccines, 
for which there are only four manufacturers licensed to sell in the 
United States. Once again, the threat of liability and the cost of 
litigation pose challenges to the stability of our vaccine supply. 
According to the March 18, 2002 edition of Forbes magazine, the profit 
margin for vaccines is very slim. Just one of the pending class action 
lawsuits seeks $30 billion in damages. The entire global value of the 
vaccine market, all around the world, is only $5 billion.
  The ``Vaccine Affordability and Availability Act'' simply ensures 
that the VICP's goal of stabilizing the vaccine market is not 
jeopardized. In establishing the VICP in 1986, Congress sought to 
ensure that individuals claiming injury from covered vaccines must 
first file for compensation under the VICP. Some individuals, however, 
have attempted to evade this requirement by arguing, for example, that 
a preservative used in a vaccine, and included in the vaccine's product 
license application and product label, is not itself a ``vaccine'' so 
the VICP restrictions do not apply to claims for injuries caused by 
preservatives. This bill restates the original intent of the law, that 
a vaccine is all the ingredients and components which are approved by 
FDA to be in the product.

[[Page S2278]]

  The bill makes necessary clarifications to the VICP to ensure that 
unwarranted litigation does not again destabilize the vaccine market 
causing the few manufacturers licensed to sell vaccines in the United 
States to leave the market resulting in even more serious shortages of 
essential vaccines. It clarifies that a vaccine-injured person must 
timely file a petition and complete the VICP process before third 
parties may bring a civil action in connection with that person's 
injuries. The bill adopts the ACCV recommendation that clarifies that 
certain well-defined medical conditions such as structural lesions and 
genetic disorders may be considered to be ``factors unrelated,'' and 
therefore non-compensable under VICP, to a vaccine, even if the exact 
defect in the gene, for example, is unknown. The legislation also 
clarifies that vaccine manufacturers and administrators cannot be sued 
unless there is evidence that a vaccine has caused present physical 
harm, they cannot be sued for medical monitoring to look for some 
theoretical future harm. The bill clarifies the definition of 
manufacturer to specify that a vaccine includes all components or 
ingredients of the vaccine and clarifies the existing law to ensure 
that any component or ingredient listed in a vaccine's product license 
application or label will not be considered to be an adulterant or 
contaminant. As with the changes we are making for VICP claimants, 
these changes would apply to pending and future VICP claims.
  This bill also requires that the Secretary of HHS prioritize, acquire 
and maintain a 6-month supply of vaccines to address future vaccine 
shortages and delays in production and authorizes new funds for this 
purpose. By authorizing additional funding for grants to State and 
local governments to increase influenza immunization rates for high 
risk populations and by authorizing funding to increase immunization 
rates for adolescents and adults who are medically underserved and at-
risk for vaccine-preventable diseases, this bill seeks to meet the 
challenge of improving adolescent and adult immunization rates. 
Finally, it ensures that colleges, universities and prisons are given 
information about the availability of a vaccine for bacterial 
meningitis and that health care clinics and providers are given 
information about the availability of hepatitis A and B vaccines.
  In summary, the ``Vaccine Affordability and Availability Act'' 
clarifies, updates, and streamlines the existing Vaccine Injury 
Compensation Program to address concerns of petitioners to the program, 
to ensure that we are better prepared for normal market shortages and 
delays in production and that unwarranted litigation does not further 
destabilize our vaccine supply. I urge my colleagues to support this 
much needed legislation to improve the way the VICP operates for 
claimants seeking compensation and for manufacturers and administrators 
of vaccines seeking greater certainty in liability exposure, which, in 
turn, will stabilize vaccine production.
  This bill will help to ensure that the balance between the two very 
important goals of the Vaccine Injury Compensation Program is 
maintained: To provide for fair and expeditious compensation for 
persons injured by covered vaccines; and to ensure a stable supply of 
vaccines by avoiding unwarranted litigation relating to vaccine-related 
injuries and deaths. I urge my colleagues to support and pass this much 
needed legislation at a time when liability concerns once again 
threaten our vaccine supply.
  I ask unanimous consent the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2053

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

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Improved 
     Vaccine Affordability and Availability Act''.
       (b) Table of Contents.--The table of contents of this Act 
     is as follows:

Sec. 1. Short title; table of contents.

                     TITLE I--STATE VACCINE GRANTS

Sec. 101. Availability of influenza vaccine.
Sec. 102. Program for increasing immunization rates for adults and 
              adolescents; collection of additional immunization data.
Sec. 103. Immunization awareness.
Sec. 104. Supply of vaccines.

             TITLE II--VACCINE INJURY COMPENSATION PROGRAM

Sec. 201. Administrative revision of vaccine injury table.
Sec. 202. Equitable relief.
Sec. 203. Parent petitions for compensation.
Sec. 204. Jurisdiction to dismiss actions improperly brought. 
Sec. 205. Application.
Sec. 206. Clarification of when injury is caused by factor unrelated to 
              administration of vaccine.
Sec. 207. Increase in award in the case of a vaccine-related death and 
              for pain and suffering.
Sec. 208. Basis for calculating projected lost earnings.
Sec. 209. Allowing compensation for family counseling expenses and 
              expenses of establishing guardianship.
Sec. 210. Allowing payment of interim costs.
Sec. 211. Procedure for paying attorneys' fees.
Sec. 212. Extension of statute of limitations.
Sec. 213. Advisory commission on childhood vaccines.
Sec. 214. Clarification of standards of responsibility.
Sec. 215. Clarification of definition of manufacturer.
Sec. 216. Clarification of definition of vaccine-related injury or 
              death.
Sec. 217. Clarification of definition of vaccine.
Sec. 218. Conforming amendment to trust fund provision.
Sec. 219. Ongoing review of childhood vaccine data.
Sec. 220. Pending actions.
Sec. 221. Report.

                     TITLE I--STATE VACCINE GRANTS

     SEC. 101. AVAILABILITY OF INFLUENZA VACCINE.

       Section 317(j) of the Public Health Service Act (42 U.S.C. 
     247b(j)) is amended by adding at the end the following:
       ``(3)(A) For the purpose of carrying out activities 
     relating to influenza vaccine under the immunization program 
     under this subsection, there are authorized to be 
     appropriated such sums as may be necessary for each of fiscal 
     years 2003 and 2004. Such authorization shall be in addition 
     to amounts available under paragraphs (1) and (2) for such 
     purpose.
       ``(B) The authorization of appropriations established in 
     subparagraph (A) shall not be effective for a fiscal year 
     unless the total amount appropriated under paragraphs (1) and 
     (2) for the fiscal year is not less than such total for 
     fiscal year 2000.
       ``(C) The purposes for which amounts appropriated under 
     subparagraph (A) are available to the Secretary include 
     providing for improved State and local infrastructure for 
     influenza immunizations under this subsection in accordance 
     with the following:
       ``(i) Increasing influenza immunization rates in 
     populations considered by the Secretary to be at high risk 
     for influenza-related complications and in their contacts.
       ``(ii) Recommending that health care providers actively 
     target influenza vaccine that is available in September, 
     October, and November to individuals who are at increased 
     risk for influenza-related complications and to their 
     contacts.
       ``(iii) Providing for the continued availability of 
     influenza immunizations through December of such year, and 
     for additional periods to the extent that influenza vaccine 
     remains available.
       ``(iv) Encouraging States, as appropriate, to develop 
     contingency plans (including plans for public and 
     professional educational activities) for maximizing influenza 
     immunizations for high-risk populations in the event of a 
     delay or shortage of influenza vaccine.
       ``(D) The Secretary shall submit to the Committee on Energy 
     and Commerce of the House of Representatives, and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate, periodic reports describing the activities of the 
     Secretary under this subsection regarding influenza vaccine. 
     The first such report shall be submitted not later than June 
     6, 2003, the second report shall be submitted not later than 
     June 6, 2004, and subsequent reports shall be submitted 
     biennially thereafter.''.

     SEC. 102. PROGRAM FOR INCREASING IMMUNIZATION RATES FOR 
                   ADULTS AND ADOLESCENTS; COLLECTION OF 
                   ADDITIONAL IMMUNIZATION DATA.

       (a) Activities of Centers for Disease Control and 
     Prevention.--Section 317(j) of the Public Health Service Act 
     (42 U.S.C. 247b(j)), as amended by section 101, is further 
     amended by adding at the end the following:
       ``(4)(A) For the purpose of carrying out activities to 
     increase immunization rates for adults and adolescents 
     through the immunization program under this subsection, and 
     for the purpose of carrying out subsection (k)(2), there are 
     authorized to be appropriated $50,000,000 for fiscal year 
     2003, and such sums as may be necessary for each of the 
     fiscal years 2004 through 2006. Such authorization is in 
     addition to amounts available under paragraphs (1), (2), and 
     (3) for such purposes.
       ``(B) In expending amounts appropriated under subparagraph 
     (A), the Secretary shall give priority to adults and 
     adolescents who are medically underserved and are at risk for 
     vaccine-preventable diseases, including as appropriate 
     populations identified through projects under subsection 
     (k)(2)(E).

[[Page S2279]]

       ``(C) The purposes for which amounts appropriated under 
     subparagraph (A) are available include (with respect to 
     immunizations for adults and adolescents) the payment of the 
     costs of storing vaccines, outreach activities to inform 
     individuals of the availability of the immunizations, and 
     other program expenses necessary for the establishment or 
     operation of immunization programs carried out or supported 
     by States or other public entities pursuant to this 
     subsection.
       ``(5) The Secretary shall annually submit to Congress a 
     report that--
       ``(A) evaluates the extent to which the immunization system 
     in the United States has been effective in providing for 
     adequate immunization rates for adults and adolescents, 
     taking into account the applicable year 2010 health 
     objectives established by the Secretary regarding the health 
     status of the people of the United States; and
       ``(B) describes any issues identified by the Secretary that 
     may affect such rates.
       ``(6) In carrying out this subsection and paragraphs (1) 
     and (2) of subsection (k), the Secretary shall consider 
     recommendations regarding immunizations that are made in 
     reports issued by the Institute of Medicine.''.
       (b) Research, Demonstrations, and Education.--Section 
     317(k) of the Public Health Service Act (42 U.S.C. 247b(k)) 
     is amended--
       (1) by redesignating paragraphs (2) through (4) as 
     paragraphs (3) through (5), respectively; and
       (2) by inserting after paragraph (1) the following:
       ``(2) The Secretary, directly and through grants under 
     paragraph (1), shall provide for a program of research, 
     demonstration projects, and education in accordance with the 
     following:
       ``(A) The Secretary shall coordinate with public and 
     private entities (including nonprofit private entities), and 
     develop and disseminate guidelines, toward the goal of 
     ensuring that immunizations are routinely offered to adults 
     and adolescents by public and private health care providers.
       ``(B) The Secretary shall cooperate with public and private 
     entities to obtain information for the annual evaluations 
     required in subsection (j)(5)(A).
       ``(C) The Secretary shall (relative to fiscal year 2001) 
     increase the extent to which the Secretary collects data on 
     the incidence, prevalence, and circumstances of diseases and 
     adverse events that are experienced by adults and adolescents 
     and may be associated with immunizations, including 
     collecting data in cooperation with commercial laboratories.
       ``(D) The Secretary shall ensure that the entities with 
     which the Secretary cooperates for purposes of subparagraphs 
     (A) through (C) include managed care organizations, 
     community-based organizations that provide health services, 
     and other health care providers.
       ``(E) The Secretary shall provide for projects to identify 
     racial and ethnic minority groups and other health disparity 
     populations for which immunization rates for adults and 
     adolescents are below such rates for the general population, 
     and to determine the factors underlying such disparities.''.

     SEC. 103. IMMUNIZATION AWARENESS.

       (a) Development of Information Concerning Meningitis.--
       (1) In general.--The Secretary of Health and Human 
     Services, in consultation with the Director of the Centers 
     for Disease Control and Prevention, shall develop and make 
     available to entities described in paragraph (2) information 
     concerning bacterial meningitis and the availability and 
     effectiveness of vaccinations for populations targeted by the 
     Advisory Committee of Immunization Practices (an advisory 
     committee established by the Secretary Health and Human 
     Services, acting through the Centers for Disease Control and 
     Prevention).
       (2) Entities.--An entity is described in this paragraph if 
     the entity--
       (A) is--
       (i) a college or university; or
       (ii) a prison or other detention facility; and
       (B) is determined appropriate by the Secretary of Health 
     and Human Services.
       (b) Development of Information Concerning Hepatitis.--
       (1) In general.--The Secretary of Health and Human 
     Services, in consultation with the Director of the Centers 
     for Disease Control and Prevention, shall develop and make 
     available to entities described in paragraph (2) information 
     concerning hepatitis A and B and the availability and 
     effectiveness of vaccinations with respect to such diseases.
       (2) Entities.--An entity is described in this paragraph if 
     the entity--
       (A) is--
       (i) a health care clinic that serves individuals diagnosed 
     as being infected with HIV or as having other sexually 
     transmitted diseases;
       (ii) an organization or business that counsels individuals 
     about international travel or who arranges for such travel;
       (iii) a police, fire or emergency medical services 
     organization that responds to natural or man-made disasters 
     or emergencies;
       (iv) a prison or other detention facility;
       (v) a college or university; or
       (vi) a public health authority or children's health service 
     provider in areas of intermediate or high endemnicity for 
     hepatitis A as defined by the Centers for Disease Control and 
     Prevention; and
       (B) is determined appropriate by the Secretary of Health 
     and Human Services.

     SEC. 104. SUPPLY OF VACCINES.

       (a) In General.--The Secretary of Health and Human 
     Services, acting through the Director of the Centers for 
     Disease Control and Prevention, shall prioritize, acquire, 
     and maintain a supply of such prioritized vaccines sufficient 
     to provide vaccinations throughout a 6-month period.
       (b) Proceeds.--Any proceeds received by the Secretary of 
     Health and Human Services from the sale of vaccines contained 
     in the supply described in subsection (a), shall be available 
     to the Secretary for the purpose of purchasing additional 
     vaccines for the supply. Such proceeds shall remain available 
     until expended.
       (c) Authorization of Appropriations.--There are authorized 
     to be appropriated for the purpose of carrying out subsection 
     (a) such sums as may be necessary for each of fiscal years 
     2003 through 2008.

             TITLE II--VACCINE INJURY COMPENSATION PROGRAM

     SEC. 201. ADMINISTRATIVE REVISION OF VACCINE INJURY TABLE.

       The second sentence of section 2114(c)(1) of the Public 
     Health Service Act (42 U.S.C. 300aa-14(c)(1)) is amended to 
     read as follows: ``In promulgating such regulations, the 
     Secretary shall provide for notice and for at least 90 days 
     opportunity for public comment.''.

     SEC. 202. EQUITABLE RELIEF.

       Section 2111(a)(2)(A) of the Public Health Service Act (42 
     U.S.C. 300aa-11(a)(2)(A)) is amended by striking ``No 
     person'' and all that follows through ``and--'' and inserting 
     the following: ``No person may bring or maintain a civil 
     action against a vaccine administrator or manufacturer in a 
     State or Federal court for damages arising from, or equitable 
     relief relating to, a vaccine-related injury or death 
     associated with the administration of a vaccine after October 
     1, 1988 and no such court may award damages or equitable 
     relief for any such vaccine-related injury or death, unless 
     the person proves present physical injury and a timely 
     petition has been filed, in accordance with section 2116 for 
     compensation under the Program for such injury or death and--
     ''.

     SEC. 203. PARENT PETITIONS FOR COMPENSATION.

       Section 2111(a)(2) of the Public Health Service Act (42 
     U.S.C. 300aa-(a)(2)) is amended--
       (1) in subparagraph (B), by inserting ``or (B)'' after 
     ``subparagraph (A)'';
       (2) by redesignating subparagraph (B) as subparagraph (C); 
     and
       (3) by inserting after subparagraph (A) the following:
       ``(B) No parent or other third party may bring or maintain 
     a civil action against a vaccine administrator or 
     manufacturer in a Federal or State court for damages or 
     equitable relief relating to a vaccine-related injury or 
     death, including but not limited to damages for loss of 
     consortium, society, companionship or services, loss of 
     earnings, medical or other expenses, and emotional distress, 
     and no court may award damages or equitable relief in such an 
     action unless the action is joined with a civil action 
     brought by the person whose vaccine-related injury is the 
     basis for the parent's or other third party's action and that 
     person has satisfied the conditions of subparagraph (A).''.

     SEC. 204. JURISDICTION TO DISMISS ACTIONS IMPROPERLY BROUGHT.

       Section 2111(a)(3) of the Public Health Service Act (42 
     U.S.C. 300aa-11(a)(3)) is amended by adding at the end the 
     following: ``If any civil action which is barred under 
     subparagraph (A) or (B) of paragraph (2) is filed or 
     maintained in a State court, or any vaccine administrator or 
     manufacturer is made a party to any civil action brought in 
     State court (other than a civil action which may be brought 
     under paragraph (2)) for damages or equitable relief for a 
     vaccine-related injury or death associated with the 
     administration of a vaccine after October 1, 1988, the civil 
     action may be removed by the defendant or defendants to the 
     United States Court of Federal Claims, which shall have 
     jurisdiction over such civil action, and which shall dismiss 
     such action. The notice required by section 1446 of title 28, 
     United States Code, shall be filed with the United States 
     Court of Federal Claims, and that court shall proceed in 
     accordance with sections 1446 through 1451 of title 28, 
     United States Code.''.

     SEC. 205. APPLICATION.

       Section 2111(a)(9) of the Public Health Service Act (42 
     U.S.C. 300aa-11(a)(9)) is amended by striking ``This'' and 
     inserting ``Except as provided in subsection(a)(2), this''.

     SEC. 206. CLARIFICATION OF WHEN INJURY IS CAUSED BY FACTOR 
                   UNRELATED TO ADMINISTRATION OF VACCINE.

       Section 2113(a)(2)(B) of the Public Health Service Act (42 
     U.S.C. 300aa-13(a)(2)(B)) is amended--
       (1) by inserting ``structural lesions, genetic disorders,'' 
     after ``and related anoxia)'';
       (2) by inserting ``(without regard to whether the cause of 
     the infection, toxin, trauma, structural lesion, genetic 
     disorder, or metabolic disturbance is known)'' after 
     ``metabolic disturbances''; and
       (3) by striking ``but'' and inserting ``and''.

     SEC. 207. INCREASE IN AWARD IN THE CASE OF A VACCINE-RELATED 
                   DEATH AND FOR PAIN AND SUFFERING.

       Section 2115(a) of the Public Health Service Act (42 U.S.C. 
     300aa-15(a)) is amended--
       (1) in paragraph (2), by striking ``$250,000'' and 
     inserting ``$350,000''; and

[[Page S2280]]

       (2) in paragraph (4), by striking ``$250,000'' and 
     inserting ``$350,000''.

     SEC. 208. BASIS FOR CALCULATING PROJECTED LOST EARNINGS.

       Section 2115(a)(3)(B) of the Public Health Service Act (42 
     U.S.C. 300aa-15(a)(3)(B)) is amended by striking ``loss of 
     earnings'' and all that follows and inserting the following: 
     ``loss of earnings determined on the basis of the annual 
     estimate of the average (mean) gross weekly earnings of wage 
     and salary workers age 18 and over (excluding the 
     incorporated self-employed) in the private non-farm sector 
     (which includes all industries other than agricultural 
     production crops and livestock), as calculated annually by 
     the Bureau of Labor Statistics from the quarter sample data 
     of the Current Population Survey, or as calculated by such 
     similar method as the Secretary may prescribe by regulation, 
     less appropriate taxes and the average cost of a health 
     insurance policy, as determined by the Secretary.''.

     SEC. 209. ALLOWING COMPENSATION FOR FAMILY COUNSELING 
                   EXPENSES AND EXPENSES OF ESTABLISHING 
                   GUARDIANSHIP.

       (a) Family Counseling Expenses in Post-1988 Cases.--Section 
     2115(a) of the Public Health Service Act (42 U.S.C. 300aa-
     15(a)) is amended by adding at the end to following:
       ``(5) Actual unreimbursable expenses that have been or will 
     be incurred for family counseling as is determined to be 
     reasonably necessary and that result from the vaccine-related 
     injury from which the petitioner seeks compensation.''.
       (b) Expenses of Establishing Guardianships in Post-1988 
     Cases.--Section 2115(a) of the Public Health Service Act (42 
     U.S.C. 300aa-15(a)), as amended by subsection (a), is further 
     amended by adding at the end the following:
       ``(6) Actual unreimbursable expenses that have been, or 
     will be reasonably incurred to establish and maintain a 
     guardianship or conservatorship for an individual who has 
     suffered a vaccine-related injury, including attorney fees 
     and other costs incurred in a proceeding to establish and 
     maintain such guardianship or conservatorship.''.
       (c) Conforming Amendment for Cases From 1988 and Earlier.--
     Section 2115(b) of the Public Health Service Act (42 U.S.C. 
     300aa-15(b)) is amended--
       (1) in paragraph (2), by striking ``and'' at the end;
       (2) in paragraph (3), by inserting a closed parenthesis 
     before the period in that paragraph;
       (3) by redesignating paragraph (3) as paragraph (5); and
       (4) by inserting after paragraph (2), the following:
       ``(3) family counseling expenses (as provided for in 
     paragraph (5) of subsection (a));
       ``(4) expenses of establishing guardianships (as provided 
     for in paragraph (6) of subsection (a)); and''.

     SEC. 210. ALLOWING PAYMENT OF INTERIM COSTS.

       Section 2115(e) of the Public Health Service Act (42 U.S.C. 
     300aa-15(e)) is amended by adding at the end the following:
       ``(4) A special master or court may make an interim award 
     of costs if--
       ``(A) the case involves a vaccine administered on or after 
     October 1, 1988;
       ``(B) the award is limited to other costs (within the 
     meaning of paragraph (1)(B)) incurred in the proceeding; and
       ``(C) the petitioner provides documentation verifying the 
     expenditure of the amount for which compensation is 
     sought.''.

     SEC. 211. PROCEDURE FOR PAYING ATTORNEYS' FEES.

       Section 2115(e) of the Public Health Service Act (42 U.S.C. 
     300aa-15(e)), as amended by section 205, is further amended 
     by adding at the end the following:
       ``(5) When a special master or court awards attorney fees 
     or costs under paragraph (1) or (4), it may order that such 
     fees or costs be payable solely to the petitioner's attorney 
     if--
       ``(A) the petitioner expressly consents; or
       ``(B) the special master or court determines, after 
     affording to the Secretary and to all interested persons the 
     opportunity to submit relevant information, that--
       ``(i) the petitioner cannot be located or refuses to 
     respond to a request by the special master or court for 
     information, and there is no practical alternative means to 
     ensure that the attorney will be reimbursed for such fees or 
     costs expeditiously; or
       ``(ii) there are otherwise exceptional circumstances and 
     good cause for paying such fees or costs solely to the 
     petitioner's attorney.''.

     SEC. 212. EXTENSION OF STATUTE OF LIMITATIONS.

       (a) General Rule.--Section 2116(a) of the Public Health 
     Service Act (42 U.S.C. 300aa-16(a)) is amended--
       (1) in paragraph (2) by striking ``36 months'' and 
     inserting ``6 years''; and
       (2) in paragraph (3), by striking ``48 months'' and 
     inserting ``6 years''.
       (b) Claims Based on Revisions to Table.--Strike all of 
     section 2116(b) of the Public Health Service Act (42 U.S.C. 
     300aa-16(b)) and insert the following:
       ``(b) Effect of Revised Table.--If at any time the Vaccine 
     Injury Table is revised and the effect of such revision is to 
     make an individual eligible for compensation under the 
     program, where, before such revision, such individual was not 
     eligible for compensation under the program, or to 
     significantly increase the likelihood that an individual will 
     be able to obtain compensation under the program, such person 
     may, and must before filing a civil action for equitable 
     relief or monetary damages, notwithstanding section 
     2111(b)(2), file a petition for such compensation if--
       ``(1) the vaccine-related death or injury with respect to 
     which the petition is filed occurred not more than 8 years 
     before the effective date of the revision of the table; and
       ``(2) either--
       ``(A) the petition satisfies the conditions described in 
     subsection (a); or
       ``(B) the date of the occurrence of the first symptom or 
     manifestation of onset of the injury occurred more than 4 
     years before the petition is filed, and the petition is filed 
     not more than 2 years after the effective date of the 
     revision of the table.''.

     SEC. 213. ADVISORY COMMISSION ON CHILDHOOD VACCINES.

       (a) Selection of Persons Injured by Vaccines as Public 
     Members.--Section 2119(a)(1)(B) of the Public Health Service 
     Act (42 U.S.C. 300aa-19(a)(1)(B)) is amended by striking ``of 
     whom'' and all that follows and inserting the following: ``of 
     whom 1 shall be the legal representative of a child who has 
     suffered a vaccine-related injury or death, and at least 1 
     other shall be either the legal representative of a child who 
     has suffered a vaccine-related injury or death or an 
     individual who has personally suffered a vaccine-related 
     injury.''.
       (b) Mandatory Meeting Schedule Eliminated.--Section 2119(c) 
     of the Public Health Service Act (42 U.S.C. 300aa-19(c)) is 
     amended by striking ``not less often than four times per year 
     and''.

     SEC. 214. CLARIFICATION OF STANDARDS OF RESPONSIBILITY.

       (a) General Rule.--Section 2122(a) of the Public Health 
     Service Act (42 U.S.C. 300aa-22(a)) is amended by striking 
     ``and (e) State law shall apply to a civil action brought for 
     damages'' and inserting ``(d), and (f) State law shall apply 
     to a civil action brought for damages or equitable relief''; 
     and
       (b) Unavoidable Adverse Side Effects.--Section 2122(b)(1) 
     of the Public Health Service Act (42 U.S.C. 300aa-22(b)(1)) 
     is amended by inserting ``or equitable relief'' after ``for 
     damages''.
       (c) Direct Warnings.--Section 2122(c) of the Public Health 
     Service Act (42 U.S.C. 300aa-22(c)) is amended by inserting 
     ``or equitable relief'' after ``for damages''.
       (d) Construction.--Section 2122(d) of the Public Health 
     Service Act (42 U.S.C. 300aa-22(d)) is amended--
       (1) by inserting ``or equitable relief'' after ``for 
     damages''; and
       (2) by inserting ``or relief'' after ``which damages''.
       (e) Present Physical Injury.--Section 2122 of the Public 
     Health Service Act (42 U.S.C. 300aa-22) is amended--
       (1) by redesignating subsections (d) and (e) as subsections 
     (e) and (f), respectively; and
       (2) by inserting after subsection (c) the following:
       ``(d) Present Physical Injury.--No vaccine manufacturer or 
     vaccine administrator shall be liable in a civil action 
     brought after October 1, 1988, for equitable or monetary 
     relief absent proof of present physical injury from the 
     administration of a vaccine, nor shall any vaccine 
     manufacturer or vaccine administrator be liable in any such 
     civil action for claims of medical monitoring, or increased 
     risk of harm.''.

     SEC. 215. CLARIFICATION OF DEFINITION OF MANUFACTURER.

       Section 2133(3) of the Public Health Service Act (42 U.S.C. 
     300aa-33(3)) is amended--
       (1) in the first sentence, by striking ``under its label 
     any vaccine set forth in the Vaccine Injury Table'' and 
     inserting ``any vaccine set forth in the Vaccine Injury 
     table, including any component or ingredient of any such 
     vaccine''; and
       (2) in the second sentence, by inserting ``including any 
     component or ingredient of any such vaccine'' before the 
     period.

     SEC. 216. CLARIFICATION OF DEFINITION OF VACCINE-RELATED 
                   INJURY OR DEATH.

       Section 2133(5) of the Public Health Service Act (42 U.S.C. 
     300aa-33(5)) is amended by adding at the end the following: 
     ``For purposes of the preceding sentence, an adulterant or 
     contaminant shall not include any component or ingredient 
     listed in a vaccine's product license application or product 
     label.''.

     SEC. 217. CLARIFICATION OF DEFINITION OF VACCINE.

       Section 2133 of the Public Health Service Act (42 U.S.C. 
     300aa-33) is amended by adding at the end the following:
       ``(7) The term `vaccine' means any preparation or 
     suspension, including but not limited to a preparation or 
     suspension containing an attenuated or inactive microorganism 
     or subunit thereof or toxin, developed or administered to 
     produce or enhance the body's immune response to a disease or 
     diseases and includes all components and ingredients listed 
     in the vaccines's product license application and product 
     label.''.

     SEC. 218. CONFORMING AMENDMENT TO TRUST FUND PROVISION.

       Section 9510(c)(1)(A) of the Internal Revenue Code of 1986 
     is amended by striking ``October 18, 2000'' and inserting 
     ``the effective date of the Improved Vaccine Affordability 
     and Availability Act''.

     SEC. 219. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.

       Part C of title XXI of the Public Health Service Act (42 
     U.S.C. 300a-25 et seq.) is amended by adding at the end the 
     following:

[[Page S2281]]

     ``SEC. 2129. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.

       ``(a) In General.--Not later than 6 months after the date 
     of enactment of this section, the Secretary shall enter into 
     a contract with the Institute of Medicine of the National 
     Academy of Science under which the Institute shall conduct an 
     ongoing, comprehensive review of new scientific data on 
     childhood vaccines (according to priorities agreed upon from 
     time to time by the Secretary and the Institute of Medicine).
       ``(b) Reports.--Not later than 3 years after the date on 
     which the contract is entered into under paragraph (1), the 
     Institute of Medicine shall submit to the Secretary a report 
     on the findings of studies conducted, including findings as 
     to any adverse events associated with childhood vaccines, 
     including conclusions concerning causation of adverse events 
     by such vaccines, together with recommendations for changes 
     in the Vaccine Injury Table, and other appropriate 
     recommendations, based on such findings and conclusions.
       ``(c) Failure To Enter Into Contract.--If the Secretary and 
     the Institute of Medicine are unable to enter into the 
     contract described in paragraph (1), the Secretary shall 
     enter into a contract with another qualified nongovernmental 
     scientific organization for the purposes described in 
     paragraphs (1) and (2).
       ``(d) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated such sums as 
     may be necessary for each of fiscal years 2003, 2004, 2005 
     and 2006.''.

     SEC. 220. PENDING ACTIONS.

       The amendments made by this title shall apply to all 
     actions or proceedings pending on or after the date of 
     enactment of this Act.

     SEC. 221. REPORT.

       Not later than 1 year after the date of enactment of this 
     Act, the Secretary of Health and Human Services shall submit 
     recommendations regarding how to address the growing surplus 
     in the Vaccine Trust Fund, and the rationale for such 
     recommendations to--
       (1) the Health, Education, Labor and Pensions Committee of 
     the Senate;
       (2) the Finance Committee of the Senate;
       (3) the Energy and Commerce Committee of the House of 
     Representatives; and
       (4) the Ways and Means Committee of the House of 
     Representatives.
                                 ______