[House Report 106-977]
[From the U.S. Government Publishing Office]



                                                 Union Calendar No. 575

106th Congress, 2d Session -  -  -  -  -  -  -  -  House Report 106-977
_______________________________________________________________________


    THE VACCINE INJURY COMPENSATION PROGRAM: ADDRESSING NEEDS AND 
                          IMPROVING PRACTICES

                               __________

                              SIXTH REPORT

                                 by the

                     COMMITTEE ON GOVERNMENT REFORM


                                     


                                     

  Available via the World Wide Web: http://www.gpo.gov/congress/house
                      http://www.house.gov/reform

October 12, 2000.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                               __________

                    U.S. GOVERNMENT PRINTING OFFICE
67-193 CC                  WASHINGTON : 2000


                     COMMITTEE ON GOVERNMENT REFORM

                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut       ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
STEPHEN HORN, California             PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida                PATSY T. MINK, Hawaii
THOMAS M. DAVIS III, Virginia        CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana           ELEANOR HOLMES NORTON, District of 
MARK E. SOUDER, Indiana                  Columbia
JOE SCARBOROUGH, Florida             CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South     DENNIS J. KUCINICH, Ohio
    Carolina                         ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia                    DANNY K. DAVIS, Illinois
DAN MILLER, Florida                  JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
LEE TERRY, Nebraska                  THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois               HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California                             ------
PAUL RYAN, Wisconsin                 BERNARD SANDERS, Vermont 
HELEN CHENOWETH-HAGE, Idaho              (Independent)
DAVID VITTER, Louisiana


                      Kevin Binger, Staff Director
                 Daniel R. Moll, Deputy Staff Director
           David A. Kass, Deputy Counsel and Parliamentarian
                     Robert A. Briggs, Chief Clerk
                 Phil Schiliro, Minority Staff Director

   Subcommittee on Criminal Justice, Drug Policy, and Human Resources

                    JOHN L. MICA, Florida, Chairman
BOB BARR, Georgia                    PATSY T. MINK, Hawaii
BENJAMIN A. GILMAN, New York         EDOLPHUS TOWNS, New York
CHRISTOPHER SHAYS, Connecticut       ELIJAH E. CUMMINGS, Maryland
ILEANA ROS-LEHTINEN, Florida         DENNIS J. KUCINICH, Ohio
MARK E. SOUDER, Indiana              ROD R. BLAGOJEVICH, Illinois
STEVEN C. LaTOURETTE, Ohio           JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
DOUG OSE, California                 JANICE D. SCHAKOWSKY, Illinois
DAVID VITTER, Louisiana

                               Ex Officio

DAN BURTON, Indiana                  HENRY A. WAXMAN, California
           Sharon Pinkerton, Staff Director and Chief Counsel
                   Steve Dillingham, Special Counsel
                Lisa Wandler, Professional Staff Member
                           Ryan McKee, Clerk
                    Sarah Despres, Minority Counsel
                       Paul Kim, Minority Counsel
?

                         LETTER OF TRANSMITTAL

                                  House of Representatives,
                                  Washington, DC, October 12, 2000.
Hon. J. Dennis Hastert,
Speaker of the House of Representatives,
Washington, DC.
    Dear Mr. Speaker: By direction of the Committee on 
Government Reform, I submit herewith the committee's sixth 
report to the 106th Congress. The committee's report is based 
on a study conducted by its Subcommittee on Criminal Justice, 
Drug Policy, and Human Resources.
                                                Dan Burton,
                                                          Chairman.


                                     

                         C O N T E N T S

                          _____________
                                                                   Page
  I. Summary..........................................................1
 II. Background.......................................................2
         National Childhood Vaccine Injury Act...................     2
         National Vaccine Injury Compensation Program............     3
         Advisory Commission on Childhood Vaccines...............     4
         National Vaccine Advisory Committee.....................     4
         Vaccine information statements..........................     4
         Assessments of causality................................     5
         Childhood vaccine studies...............................     5
         Compensation procedures.................................     6
         Standards of proof......................................     7
         Vaccine injury table....................................     8
         Vaccine Adverse Event Reporting System..................     9
         Vaccine Safety Datalink Project.........................     9
III. Compensation program issues.....................................10
         Table changes...........................................    10
         Compensation determination and award delays.............    12
         Adversarial process.....................................    12
         Sovereign immunity......................................    14
         Compensation trust fund.................................    14
         Vaccine Adverse Events Reporting System.................    15
         Dual and conflicting responsibilities...................    16
 IV. Legislative proposals...........................................16
         Proposals of the Department of Health and Human Services    16
         Additional proposals....................................    17
  V. Congressional hearings..........................................18
         Subcommittee hearings...................................    18
         Full committee hearings.................................    19


  
                                                 Union Calendar No. 575
106th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     106-977

======================================================================



 
THE VACCINE INJURY COMPENSATION PROGRAM: ADDRESSING NEEDS AND IMPROVING 
                               PRACTICES

                                _______
                                

October 12, 2000.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

   Mr. Burton, from the Committee on Government Reform submitted the 
                               following

                              SIXTH REPORT

    On October 5, 2000, the Committee on Government Reform 
approved and adopted a report entitled, ``The Vaccine Injury 
Compensation Program: Addressing Needs and Improving 
Practices.'' The chairman was directed to transmit a copy to 
the Speaker of the House.

                               I. Summary

    Responding to the complaints of families reporting vaccine 
injury and pursuant to its authority, the Subcommittee on 
Criminal Justice, Drug Policy, and Human Resources (the 
subcommittee) initiated an oversight investigation into the 
implementation and operation of the National Childhood Vaccine 
Injury Act of 1986 (the Act) as administered jointly by the 
Department of Health and Human Services [HHS], the Department 
of Justice [DOJ] and the U.S. Court of Federal Claims (the 
Court).
    The Act serves three purposes: (1) Provide fair, expedited 
compensation to those who suffer vaccine injury through the 
National Vaccine Injury compensation ([VICP] or the Program); 
(2) Enhance the operation of our system of childhood 
immunizations; and (3) Protect the Nation's vaccine supply by 
shielding manufacturers from liability.
    The Act has been highly successful in some of its 
objectives. The vaccine supply is stable and over 1,500 
petitioners and their families have been compensated. But the 
program has received criticism that it does not operate as 
efficiently or equitably as intended by Congress. Designed as a 
``no-fault'' alternative to litigation against vaccine 
manufacturers, the program was envisioned by Congress to 
compensate ``quickly, easily and with certainty and 
generosity'' those individuals who are injured or die as a 
consequence of our universal vaccination policy.
    Based on testimonial and documentary record, the 
subcommittee finds that the program under the direction of HHS 
has approved changes that substantially restrict compensation 
coverage. Furthermore, avoidable, protracted and adversarial 
litigation of claims has resulted, thereby undermining the 
remedial nature of the program as intended by the Congress.
    Accordingly, recommendations are made to:
     Review the Vaccine Injury Table (the Table) to 
ensure that it reflects current science and epidemiology;
     Continue developing and implementing speedy and 
fair informal dispute resolution options and practices; and
     Determine a reasonable alternative standard for 
non-Table cases.

                             II. Background

    Vaccination is a foundation of modern public health 
programs and is considered one of the most effective public 
health initiatives ever undertaken. Since immunization programs 
began, the number of people contracting vaccine-preventable 
diseases in the United States has been reduced by more than 95 
percent.\1\ Morbidity and mortality attributable to smallpox, 
measles, mumps, rubella, polio, diphtheria, pertussis and 
tetanus has almost been eliminated.
---------------------------------------------------------------------------
    \1\ ``Vaccine Injury Compensation: Program Challenged to Settle 
Claims Quickly and Easily,'' GAO/HEHS-00-8 (December 1999), p. 1.
---------------------------------------------------------------------------
    Over 12 million vaccinations are given to children 
annually, and many millions of vaccines are given to adults.\2\ 
States now require that virtually all children be vaccinated 
prior to entering school.
---------------------------------------------------------------------------
    \2\ Ibid., p. 4.
---------------------------------------------------------------------------
    The benefits of vaccination are measured in terms of 
prevented disease in individuals and in the population to be 
protected against infectious disease. The risks are measured as 
potential side effects and injuries. Both are monitored as part 
of the U.S. public health system. In some instances, the 
differences in the ways that immune systems react to vaccines 
on rare occasions may result in severe side effects, including 
death or disabling conditions requiring lifetime medical care.
    Despite these rare instances, it is the overwhelming view 
of the medical and public health community that the risks of 
vaccine reactions, both mild reactions and rare serious ones, 
are far outweighed by the public health benefits of current 
vaccination practices. Maintaining public support for 
immunizations is critical for preventing outbreaks of vaccine 
preventable diseases.

                 National Childhood Vaccine Injury Act

    Every year, a number of children are seriously injured by 
adverse reactions to vaccines. When such a tragedy befalls a 
family, they are faced with devastating emotional and financial 
consequences. As the devastation of adverse reactions can lead 
to paralysis, permanent disability and death, families without 
adequate insurance can face enormous expenses, including 
residential care, therapy, medical equipment, and drugs.
    Following a nationwide initiative to raise immunization 
levels among children in the late 1970's, lawsuits in the 
1980's stemming from adverse reactions threatened to negatively 
affect availability, cost and development of vaccines.
    Before the VICP was established, families experiencing 
vaccine related reactions had to rely upon traditional tort 
litigation. Families were often unable to obtain the scientific 
and legal resources needed to substantiate vaccine-related 
injuries in legal proceedings. Scientific studies and medical 
evidence needed to definitively link vaccines with various 
medical conditions were often unavailable or insufficient to 
establish the traditional level of proof required for 
compensation in the civil tort system. As lawsuits increased, 
vaccine manufacturers also were burdened with the time and 
expenses of litigation, as well as the availability and 
affordability of liability insurance. As the number of vaccine 
manufacturers fell and prices rose, physicians and public 
health professionals warned of the potential return of epidemic 
infectious diseases.\3\
---------------------------------------------------------------------------
    \3\ ``Vaccine Injury Compensation,'' GAO/HEHS-00-8, pp. 4 and 5.
---------------------------------------------------------------------------
    In response, Congress passed the National Childhood Vaccine 
Injury Act of 1986 (Public Law 99-660) (the Act) to establish a 
simple system of compensation for children suffering injuries 
related to routine pediatric immunizations. The Act created a 
National Vaccine Program and VICP, including advisory 
committees for each. The Act specifies remedies available to 
persons suffering vaccine-related injuries, establishes 
requirements regarding recordkeeping and reporting on vaccine 
administration and adverse effects, and calls for increased 
studies of vaccines. The new system for vaccine compensation 
was intended to be ``fair, simple, and easy to administer.'' 
\4\
---------------------------------------------------------------------------
    \4\ Ibid., p. 5.
---------------------------------------------------------------------------

              National Vaccine Injury Compensation Program

    Under the Act, the National Vaccine Injury Compensation 
Program ([VICP] or Program) was created to provide compensation 
to those who suffer vaccine-related injury or death. The 
Program is designed as a ``no fault'' alternative to civil 
litigation intended to be ``fair, simple, and easy to 
administer'' and ``to compensate persons with recognized 
vaccine injuries without requiring the difficult individual 
determinations of causation to injury.'' \5\
---------------------------------------------------------------------------
    \5\ ``Vaccine Injury Compensation Program,'' GAO/HEHS-00-8, p. 5.
---------------------------------------------------------------------------
    Vaccines currently covered under the Program include 
diphtheria, tetanus, pertussis (DTP, DTaP, DT, TT or Td), 
measles, mumps, rubella (MMR or any components) and polio (OPV 
or IPV). Hepatitis B, Haemophilus influenza type b (Hib), and 
varicella (chickenpox) vaccines were added for coverage, 
effective August 6, 1997. Rotavirus was added effective October 
22, 1998. Eight years of retroactive coverage from the 
effective date is provided for vaccine-related adverse events 
associated with any vaccine newly added to the Program.
    Since enactment, the Program has paid out approximately 
$1.17 billion in awards for vaccine injuries and attorney's 
fees. Disbursement for injuries related to vaccines 
administered after October 1, 1988 are provided by the trust 
fund supported by an excise tax of 75 cents on every dose of 
vaccine sold that is covered by the Program. Retrospective 
claims are paid from general fund appropriations.\6\
---------------------------------------------------------------------------
    \6\ Ibid., pp. 3-9.
---------------------------------------------------------------------------

               Advisory Commission on Childhood Vaccines

    The Advisory Commission on Childhood Vaccines [ACCV] is 
charged with monitoring the VICP and making recommendations to 
the Secretary of HHS on its implementation. It is composed of 
nine members appointed by the Secretary for 3-year terms. Three 
are healthcare professionals, of whom at least two must be 
pediatricians; three are members of the public, of whom at 
least two must be parents or guardians of vaccine injured 
children; and three are attorneys, of whom at least one is 
counsel to a petitioner and one represents manufacturers. The 
Commission meets four times a year and is required to submit 
recommendations on the Program to the Secretary of Health and 
Human Services.
    One of the primary responsibilities of the Commission is 
advising on modifications to the Table. According to the 
statute, ``The Secretary may not propose changes to the Vaccine 
Injury Table or any revision thereof, unless the Secretary has 
first provided to the Commission a copy of the proposed 
regulation or revision, requested recommendations and comments 
by the Commission and allowed the Commission at least 90 days 
to make such recommendations.''
    Controversy continues over whether, after reviewing 
proposed regulations but undergoing a substantial change in 
membership, the Commission had the opportunity to reconsider 
fully the final version of the March 1995 regulations to the 
ACCV prior to their effective date. Critics contend the 
Commission was unable to address the appropriateness of the 
amendments, in particular the definitional change of the word 
``encephalopathy'' in the ``Aids to Interpretation.'' Moreover, 
the ACCV proposed certain additions to the Table that 
subsequently were rejected by the Secretary. In contrast, HHS 
argues that the Commission reviewed the change. In 1996, HHS 
won a legal decision regarding this matter.\7\
---------------------------------------------------------------------------
    \7\ O'Connell v. Shalala, 79 F.3d 170 (1st Cir. 1996).
---------------------------------------------------------------------------

                  National Vaccine Advisory Committee

    The National Vaccine Advisory Committee [NVAC] has a broad 
mandate for reviewing and making recommendations concerning 
vaccine research, production, delivery, safety and efficacy. 
Recommendations have included ad hoc committee reviews of risks 
associated with each of the vaccines listed on the injury 
table.
    NVAC is comprised of representatives from State and local 
health departments, vaccine companies, academia, and consumer 
groups.\8\
---------------------------------------------------------------------------
    \8\ ``Vaccine Injury Compensation Program,'' GAO/HEHS-00-8, p. 13.
---------------------------------------------------------------------------

                     Vaccine Information Statements

    In an effort to establish adequate risk communication, the 
Act requires that all healthcare providers who administer 
vaccines must provide a Vaccine Information Statement [VIS] to 
the vaccine recipient, their parent or legal guardian prior to 
each dose. Each VIS contains a brief description of the disease 
as well as the risks and benefits of the vaccine. The VIS is 
developed by the Centers for Disease Control and Prevention 
[CDC] and distributed to State and local health departments as 
well as individual providers.
    Criticisms have been expressed that the VIS advisements may 
be incomplete and, in practice, there may be failures to inform 
recipients of appropriate circumstances for considering 
modification to the normal vaccination schedule or to opt out 
of receiving the vaccine. The subcommittee agrees that 
pediatricians and health care providers should fully inform 
patients about vaccine risks and benefits.

                        Assessments of Causality

    Vaccine reactions can be classified by frequency (common, 
rare), extent (local, systemic), severity (hospitalization, 
disability, death), causality, and preventability (intrinsic to 
vaccine, faulty production, faulty administration).
    Because of the large number of vaccine exposures, it is 
clear that temporal associations with adverse outcomes will 
occur even when there is no causal association. Many health 
problems in infancy will occur in children who have been 
vaccinated, and some of these problems will by chance occur in 
recently vaccinated children.
    An adverse event can be causally linked to a vaccine more 
readily if: 1) the event conforms to a specific clinical 
syndrome whose association with vaccination has strong 
biological plausibility (such as anaphylaxis immediately 
following vaccination); 2) a laboratory result confirms the 
association (i.e. viral culture and genetic sequencing show 
virus is a vaccine and not a wild strain); 3) the event recurs 
on re-administration of the vaccine (positive rechallenge); or 
4) a controlled clinical trial or carefully designed 
epidemiological study shows greater risk of adverse events 
among vaccinated than control groups.
    Because few of the adverse events reported meet any of the 
first three criteria and clinical trials are almost always too 
small to provide useful information on serious rare events, 
epidemiological evidence is the basis for assessing vaccine-
relatedness for most serious adverse events that are 
investigated. Still, much remains unknown about possible 
adverse events that may be associated with past and present 
vaccination practices.

                       Childhood Vaccine Studies

    The Act called for the Institute of Medicine [IOM] to 
review existing studies and medical literature and provide a 
foundation for recommendations on vaccine injury causation. In 
reports issued in 1991 and 1994, IOM published several 
conclusions regarding the scarcity of knowledge about vaccine 
safety, citing severe limits in data and research capability. 
Of the 76 adverse events IOM reviewed for a causal 
relationship, 50 (66 percent) had no or inadequate research.
    Specifically, IOM Committees identified the following 
limitations of existing knowledge: 1) Inadequate understanding 
of biologic mechanisms underlying adverse events; 2) 
Insufficient or inconsistent information from case reports and 
case series; 3) Inadequate size or length of follow-up of many 
population-based epidemiological studies; 4) Limitations of 
existing surveillance systems to provide persuasive evidence of 
causation, and 5) Few published epidemiological studies.
    IOM warned that ``if research capacity and accomplishments 
[are] not improved, future reviews of vaccine safety [will be] 
similarly handicapped.'' \9\ IOM recommends: ``More research 
could be done on potential long-term adverse effects from 
vaccines as well as the potential of vaccines to induce or 
worsen immune disorders.'' CDC agrees that there remains 
``uncertainty about estimates of the risk associated with 
vaccination'' and that to ``continue research to improve the 
understanding of vaccine risks is critical.'' \10\
---------------------------------------------------------------------------
    \9\ Research Strategies for Assessing Adverse Events Associated 
with Vaccines (National Academy Press, 1994).
    \10\ 1996 IOM Vaccine Safety Forum.
---------------------------------------------------------------------------
    Despite concerns of IOM, parents, public health authorities 
and other stakeholders, research needed to develop additional 
scientific evidence that conclusively addresses many issues of 
causality has not been completed. Concerns have been expressed 
that additional research is needed to address the effects of 
vaccines on chronic diseases, adverse events reporting, the 
delivery of multiple vaccines and increased rates of childhood 
vaccinations.\11\ While vaccines must be demonstrated to be 
safe and effective prior to marketing, agencies including NIH, 
FDA and CDC contend they are constrained by limited resources. 
However, in part as a response to the concerns of this 
subcommittee, HHS has recently contracted with IOM to undertake 
further vaccine safety studies.
---------------------------------------------------------------------------
    \11\ Vaccines--Finding the Balance Between Public Safety and 
Personal Choice, hearing before the House Committee on Government 
Reform, 106th Cong., 1st sess., serial No. 106-84 (1999).
---------------------------------------------------------------------------

                        Compensation Procedures

    An individual claiming injury or death from a vaccine must 
file a claim or petition with the U.S. Court of Federal Claims 
(the Court). To qualify, injury claims must be filed within 36 
months after initial onset of symptoms, and claims for deaths 
must be received within 2 years of death and 4 years after the 
onset of the vaccine-related injury from which the death 
occurred. The Secretary of HHS, as overall administrator of the 
Program, is named Respondent on behalf of the government and is 
represented by the Department of Justice [DOJ].
    A physician assigned by HHS has 90 days to review the 
petition and make a non-binding recommendation as to 
compensability, based primarily on medical records. This 
recommendation is then provided to the Court through the DOJ 
attorney assigned to the case. If the court concurs with an 
entitlement recommendation, it may obviate the need for a 
hearing.
    Those cases that are not conceded usually proceed to a 
hearing before an assigned Special Master, who acts in a 
capacity similar to an administrative law judge. Both the 
petitioner and the DOJ present testimony, including expert 
witnesses, and decisionmaking authority is vested in the 
Court's assigned Special Master.
    To expedite proceedings, formal civil discovery and rules 
of evidence have been relaxed in favor of a more informal 
process, and timelines have been established. The Special 
Master is required to issue a judgement within 240 days 
(exclusive of suspended time) from the date a claim is filed, 
or the petitioner may withdraw from the Program.
    The Special Master's decision may be appealed by either 
party to a judge of the Court, then to the U.S. Federal Circuit 
Court of Appeals, and then to the U.S. Supreme Court.\12\ 
Following adjudication, if compensation is awarded, damages are 
negotiated and future needs assessed, typically in consultation 
with medical professionals, life care planners and other 
experts. For compensable injuries, awards may take the form of 
an initial lump sum plus an annuity providing a stream of 
benefits for lifetime costs of care not covered by insurance. 
The Program does not pay punitive damages. Successful claims 
are eligible to receive reasonable compensation for past and 
future unreimbursable medical, custodial and rehabilitation 
costs; a $250,000 limit for actual and projected pain, 
suffering and emotional distress; and lost earnings. A cap of 
$250,000 was legislated as payment for compensable deaths.
---------------------------------------------------------------------------
    \12\ ``Commonly Asked Questions About the NVICP,'' HRSA.
---------------------------------------------------------------------------
    To ensure access, the Program also pays attorneys fees and 
costs for the petitioner regardless of adjudication, assuming 
there is a reasonable basis for the petition and it was filed 
in good faith. While not required, most petitioners do seek 
legal counsel to help navigate the program's procedures and the 
need for complex medical evidence.
    No petition may be filed under the Program if a civil 
action is pending for damages related to the vaccine injury, or 
if damages were previously awarded to the petitioner by a court 
or in a civil settlement against the vaccine manufacturer or 
administrator. However, lawsuits may be filed against 
manufacturers or health care providers under State law in some 
circumstances, such as when a petition is dismissed or judged 
noncompensable, or when the vaccine is not covered under the 
Program, or if the petitioner is not satisfied with the amount 
of awarded compensation.\13\
---------------------------------------------------------------------------
    \13\ ``Vaccine Injury Compensation Program,'' GAO/HEHS-00-8, p. 5.
---------------------------------------------------------------------------
    Since the program's date of inception, October 1988, 
approximately 6,000 petitions have been filed, 75 percent 
involving injury allegations from vaccines administered prior 
to the law's enactment. Of those cases, more than half (3,500) 
have resulted in dismissal. To date: 71 percent of the claims 
are for DTP/DTP-Hib; 2 percent for tetanus/Td/DT; 15 percent 
for MMR or components, 10 percent for OPV/IPV; and the 
remaining 2 percent are for new vaccines, vaccines not covered 
under the VICP, or unspecified vaccines. Awards have ranged 
from $120.00 to $7.9 million, with the average approximately 
$800,000.\14\
---------------------------------------------------------------------------
    \14\ ``Commonly Asked Questions About NVICP,'' p. 4.
---------------------------------------------------------------------------

                           Standards of Proof

    Petitioners may become eligible to receive compensation in 
three ways. First, the claimant must prove, by a preponderance 
of the evidence, that an injury listed on the Table occurred 
within the prescribed time.
    Second, if the injury is not listed on the Table or did not 
occur within the prescribed timeframe, pursuant to present 
adjudication practices, a petitioner is held to traditional and 
more difficult tort standards, and must prove traditional 
causation or ``causation-in-fact.'' Congress' guidance on 
``causation-in-fact'' cases is as follows, ``Simple similarity 
to conditions or time periods listed in the Table is not 
sufficient evidence of causation; evidence in the form of 
scientific studies or expert medical testimony is necessary to 
demonstrate causation for such a petitioner.'' \15\ Only a 
small percentage of claims found not to be covered on the Table 
receives compensation (only 13 percent).\16\
---------------------------------------------------------------------------
    \15\ House of Representatives Rept. No. 99-908 (1986), p. 5.
    \16\ ``Vaccine Injury Compensation,'' GAO/HEHS-00-8, p. 12.
---------------------------------------------------------------------------
    Finally, the petitioner may receive compensation if he or 
she demonstrates that the vaccine significantly aggravated a 
pre-existing condition. Children who do not receive 
compensation from the fund may be required to rely on other 
Federal health services that provide limited medical coverage 
and home health assistance.

                          Vaccine Injury Table

    A unique mechanism is used in the Program to provide 
petitioners with a rebuttable presumption of causation. This 
mechanism is the Table of Compensable Events, known as the 
Vaccine Injury Table (the Table) and its complementary 
Qualifications and Aids to Interpretation, which provides 
definitions for injuries and the specific circumstances under 
which the Table injuries must occur. Originally enacted in 1988 
by Congress and subsequently revised by HHS with the advice of 
experts, the Table identifies serious adverse events that 
certain experts considered to be caused by vaccines.\17\
---------------------------------------------------------------------------
    \17\ ``An Overview of Vaccine Safety,'' CDC.
---------------------------------------------------------------------------
    The Table serves to eliminate some of the uncertainty 
caused by gaps in medical knowledge by listing vaccines covered 
by the program and the injuries, disabilities, illnesses, and 
conditions (including death) for which compensation may be 
paid. It also defines the period of time during which the first 
symptom or substantial aggravation of the injury must appear.
    Provided that no ``factor unrelated'' can be established by 
the government as the cause of injury, adverse events that 
occur within the Table are presumed to be related to and caused 
by the vaccine.
    By creating a framework to allow for a presumption of cause 
and effect to exist for the claimant, the Table is intended to 
remove much of the burden of proof required in traditional tort 
proceedings. By contrast, under traditional civil litigation 
practices, the injured party bears the burden of proving that 
the vaccine caused injury. This presumptive feature is crucial 
to the integrity of a no-fault, expedited vaccine injury 
compensation system, and this approach to vaccine relatedness 
was intended as a guiding principle for the Vaccine 
Compensation Program.
    Alternative presumptions of cause and effect procedure 
already exist in other Federal health and benefit programs. For 
example, the Veterans Health Care Eligibility Reform Act of 
1996 (Public Law 104-262) (Veterans Health Care Act) requires 
the Department of Veterans Affairs [VA] to furnish hospital 
care and medical services, and may furnish nursing home care to 
veterans exposed to herbicides in Vietnam. For an Agent-Orange-
based claim by a Vietnam veteran for service-connected 
benefits, the Veterans Health Care Act requires:
     A medical diagnosis of a disease which VA 
recognizes as being associated with Agent Orange [specified 
diseases];
     Competent evidence of service in Vietnam or 
offshore in the adjacent waters between 1962 and 1975; and
     Competent medical evidence that the disease began 
within the deadline (if any).\18\
---------------------------------------------------------------------------
    \18\ Agent Orange Review, Department of Veterans Affairs, Vol. 16, 
No. 1 (May 2000).
---------------------------------------------------------------------------

                 Vaccine Adverse Event Reporting System

    The Act mandates that all health care providers report 
certain adverse events following vaccination to the Vaccine 
Adverse Event Reporting System [VAERS]. VAERS was established 
by the Food and Drug Administration [FDA] and CDC in 1990 to 
provide a unified mechanism for the collection and analysis of 
adverse events associated with vaccines currently licensed in 
the United States. Reportable vaccine adverse events are 
defined as health effects that occur after immunization that 
may or may not be related to the vaccine.\19\ 16
---------------------------------------------------------------------------
    \19\ ``An Overview of Vaccine Safety,'' CDC, p. 4.
---------------------------------------------------------------------------
    VAERS is a passive surveillance system, a repository for 
voluntarily submitted reports. An active surveillance system, 
by contrast, would follow all individuals in a defined 
population to determine their responses to vaccinations. The 
VAERS reporting form is designed to allow a narrative 
description of adverse events.
    To encourage reporting of any possibly vaccine-induced 
adverse event, the criteria for reporting to VAERS is 
nonrestrictive; the system accepts and includes any report 
submitted, no matter how tenuous the possible connection with 
vaccination might seem. All persons, including patients, 
parents and health professionals can report to VAERS with no 
restrictions on onset intervals or requirements for medical 
care.
    The Act does require that physicians report--directly to 
VAERS or to the manufacturer--certain categories of serious 
outcomes defined for regulatory purposes as an event resulting 
in death, life-threatening illness, hospitalization, 
prolongation of existing hospitalization, or permanent 
disability.
    VAERS is intended to serve as the ``front line'' of vaccine 
safety, since this type of national reporting system can 
rapidly document possible effects and generate early warning 
signals that can then be more rigorously investigated in 
focused studies. VAERS is considered especially valuable in 
assessing the safety of newly marketed vaccines.

                    Vaccine Safety Datalink Project

    The gaps that exist in the scientific knowledge of rare 
vaccine side effects prompted the CDC to develop the Vaccine 
Safety Datalink [VSD] project in 1990. This project involved 
forming partnerships with four large health maintenance 
organizations [HMOs] to continually monitor vaccine safety. VSD 
is an example of a large-linked database [LLDB] and includes 
information on more than 6 million people.
    All vaccines administered within the study population are 
recorded. Available data includes vaccine type, date, 
manufacturer, lot number concurrent vaccinations (those given 
during the same visit) and injection site. Medical records are 
then monitored for potential adverse events.
    The VSD project allows for planned vaccine safety studies 
as well as timely investigations of hypotheses. At present, the 
VSD project is examining potential associations between 
vaccines and 34 serious conditions. The database is also being 
used to test new vaccine safety hypotheses and issues from the 
medical literature, VAERS, changes in the immunization schedule 
or from the introduction of new vaccines.

            III. Vaccine Injury Compensation Program Issues

                      Vaccine Injury Table Changes

    The Childhood Vaccine Injury Act of 1986 (the Act) 
established the first Vaccine Injury Table (the Table) as an 
interim compromise until more scientific information became 
available, and granted the Secretary rulemaking authority to 
amend the Table at such time, bringing it more in line with 
current science. It also called for IOM to assist the Secretary 
in making changes by conducting a review of medical studies.
    HHS exercised its rulemaking authority to amend the Table 
and the Aids to Interpretation in 1995 and again in 1997, 
following the publication of IOM studies in 1991 and 1994, 
respectively. In the reports, IOM identified certain conditions 
that were 1) consistent or inconsistent with a causal 
relationship; 2) those that favored or did not favor a causal 
relationship; and 3) those where evidence was insufficient to 
indicate the presence or absence of a causal relationship. Most 
conditions fell in the third category, as IOM concluded there 
was insufficient medical evidence to prove or disprove a 
relationship between vaccines and two-thirds of the 75 medical 
conditions studied.
    In conjunction with public policy considerations provided 
by the ACCV, scientific issues raised by the NVAC, and input 
from the public, the Secretary added seven injuries and removed 
three others from the Table while altering definitions in the 
Aids to Interpretation. These revisions made it easier for some 
petitioners to obtain compensation, but more difficult for a 
larger number of petitioners.
    Far more claims were associated with the injuries removed 
from the Table than were associated with the injuries that were 
added. Prior to the Table revisions, three quarters of the 
claims alleged injuries on the Table, after the revisions were 
implemented, more than half of the claims filed were Table 
injuries. Of note, almost half of past claims awarded 
compensation were for injuries subsequently removed from the 
Table.\20\
---------------------------------------------------------------------------
    \20\ ``Vaccine Injury Compensation Program,'' GAO/HEHS-00-8, p. 13.
---------------------------------------------------------------------------
    Under current practices, modifications of the Table largely 
determine the types of claims for which compensation will be 
awarded. Historically, injury claims not covered under the 
Table tend to be approved for compensation far less often than 
Table injuries, and the compensation amounts are considerably 
lower.\21\ Thus, in administering and refining the Table, HHS 
defines the parameters of compensation coverage, and is able to 
limit liability through administrative changes. The 
justifications for some changes have been criticized by some 
patients, members of the petitioner's bar, and others.
---------------------------------------------------------------------------
    \21\ ``Vaccine Injury Trust Fund,'' GAO, p. 19.
---------------------------------------------------------------------------
    Recently, GAO concluded, ``Where science is insufficient to 
determine causal relationships between a vaccine and injuries, 
it is not clear that HHS' criteria and approach to making 
injury table changes are consistent.'' \22\
---------------------------------------------------------------------------
    \22\ ``Vaccine Injury Compensation,'' GAO/HEHS-00-8, p. 19.
---------------------------------------------------------------------------
    Discussing amendments to the Table, HHS cites the following 
four factors: IOM findings (and subsequent medical studies); 
biologic plausibility; recommendations from the Advisory 
Council on Childhood Vaccines [ACCV] and the National Vaccine 
Advisory Committee [NVAC]; and prevalence of the condition in 
the population attributable to vaccines. However, GAO findings 
conclude that: ``In communicating its decisions to the public, 
HHS does not uniformly discuss each of these factors, and the 
reasons why the relative importance of each factor varies among 
the decisions is not apparent in all cases.'' \23\ GAO noted:
---------------------------------------------------------------------------
    \23\ Ibid., p. 22.

          The Institute of Medicine (IOM) found that existing 
        scientific evidence favored acceptance of a causal 
        relationship between tetanus vaccines and brachial 
        neuritis, and HHS added that condition to the injury 
        table. On the other hand, the Institute also found 
        evidence of a causal relationship between the tetanus 
        and oral polio vaccines and Guillain-Barre syndrome, 
        but HHS did not add this condition to the injury table.
          The IOM found the evidence inadequate to accept or 
        reject a causal relation between vaccines and residual 
        seizure disorder, and HHS removed this condition from 
        the injury table. The Institute also found evidence 
        inadequate to accept or reject a causal relation 
        between the measles and mumps vaccines and 
        encephalopathy, yet HHS left this condition on the 
        injury table.
          HHS stated in the Federal Register that decisions not 
        to add injuries, such as Guillain-Barre syndrome, or to 
        remove injuries, such as residual seizure disorder, 
        were based to some extent on the level of risk in 
        compensating an inordinate number of non-vaccine-
        related cases for the extremely rare vaccine-related 
        case. In applying this criterion, however, HHS' 
        assumptions about the number of potential claims and 
        thresholds for deciding the reasonable level of 
        financial risk for compensating non-vaccine-related 
        injuries were not defined.\24\
---------------------------------------------------------------------------
    \24\ ``Vaccine Injury Compensation,'' GAO/HEHS-00-8, p. 15.

    Accordingly, criticisms have been expressed that certain 
procedural actions taken by HHS in revising the Table were 
inconsistent with the intent of Congress. Some changes have 
been made to the Table restricting compensation coverage for 
reasons of both science and policy. It is the view of many in 
the medical community that the Table, with its near-
determinative effect in practice upon compensation, reflects 
some of the best available scientific and epidemiological 
research. Finally, current adjudication practices generally 
assume that the Table reflects existing science and place 
unduly restrictive causation burdens on petitioners who seek to 
make claims not covered by the Table. Congress intended that a 
petitioner be given a reasonable opportunity to present 
evidence of vaccine injury relatedness even when the injury 
does not fall within the Table.

              Compensation Determination and Award Delays

    The compensation process continues to take much longer than 
Congress intended. The original legislation required a 
judgement within 1 year and was subsequently amended to require 
a decision by the Court's Special Master within 240 days. GAO 
found that 30-40 percent of claims filed each year was 
processed within 2 years.\25\ However, of the more than 5,000 
claims filed from October 1, 1988 through February 1999, only 
about 14 percent received judgment within 1 year, most did not 
receive judgment within 2 years, and almost a third received 
judgment in 5 or more years.\26\
---------------------------------------------------------------------------
    \25\ Ibid., p. 9.
    \26\ Ibid., p. 7.
---------------------------------------------------------------------------
    Significant delays in adjudication reportedly resulted from 
the volume of claims received for injuries that occurred prior 
to October 1, 1988. As the January 31, 1991 deadline to file 
these retrospective claims drew near, the number of petitions 
jumped from 125 in 1989 to 3,263 in 1990, creating an immediate 
and substantial backlog that continues to impact HHS.\27\
---------------------------------------------------------------------------
    \27\ Ibid., p. 9.
---------------------------------------------------------------------------
    Although the number of claims filed since the 1991 deadline 
has dramatically decreased, the number of claims adjudicated 
also has declined. The continued procedural delays, which 
include suspensions at the request of petitioners, reportedly 
are attributed in some instances to the government's desire to 
execute a vigorous defense.
    According to DOJ, the most common cause of delay is 
petitioner's inability to provide required medical records that 
permit a proper review of their claims. HHS data show that more 
than half of all petitioners were requested to provide 
supplementary medical records or other information, and most 
took at least a year to do so. After all the information was 
received, in most cases, it took the court over another year to 
reach its decision.\28\
---------------------------------------------------------------------------
    \28\ Ibid., p. 10.
---------------------------------------------------------------------------
    Petitions claiming injuries ``off Table,'' or not listed on 
the Table, account for some delays. According to the Chief 
Special Master, whether cases proceed under the Table or as 
causation-in-fact cases correlates directly to the amount of 
time, the number of issues presented, and the cost of 
processing cases. He explains that, prior to the enactment of 
the Table changes, the vast majority of cases (well over 90 
percent) proceeded pursuant to the Table and were resolved 
quickly. ``Causation'' cases take longer as more specialized 
experts are required, more legal and medical issues are 
presented, hearings are longer, concessions are fewer, and 
decisions are far more difficult, lengthy and time intensive. 
The duration of case proceedings and adjudications could 
increase if the number of non-Table injury cases increases.

                          Adversarial Process

    As the DOJ has pursued aggressive defenses in compensation 
cases, entitlement and compensation determinations have been 
perceived by some petitioners as being inappropriately 
adversarial in nature. According to a GAO report, the 
availability of more funds has enabled DOJ to ``establish a 
cadre of attorneys specializing in vaccine injury.'' According 
to DOJ, there are 16 trial attorneys in the vaccine 
compensation program. HHS ``established an expert witness 
program'' to challenge claims.\29\ It is also important to note 
that Program procedural changes may need approval from the 
Court.
---------------------------------------------------------------------------
    \29\ ``Vaccine Injury Trust Fund,'' GAO/HEHS-0067, p. 10.
---------------------------------------------------------------------------
    During our September 28, 1999 hearing, the Subcommittee on 
Criminal Justice, Drug Policy, and Human Resources (the 
subcommittee) received testimony from petitioners, their 
experts and attorneys charging that the governments' defense 
has, in the words of one witness, ``become increasingly 
stubborn and aggressive, to the point that in its spirit, it is 
now indistinguishable from the adversarial manner in which some 
civil lawsuits are conducted.''
    DOJ asserts that many attorneys in the petitioners' bar 
speak highly of the compensation process and the cooperative 
efforts of government counsel. Contrary to DOJ's views, critics 
cite a number of questionable practices by DOJ, even with the 
sanction of the Court, appeals resulting in multiple 
entitlement hearings, aggressive use by government of expert 
witnesses and investigators, and highly adversarial conduct 
aimed at impeaching petitioner experts. Other criticisms are 
noted below:
         DOJ attorneys make full use of the apparently 
        limitless resources available to them. They substitute 
        one expert for another if the opinion rendered by the 
        first is unfavorable or seems not to impress the court, 
        essentially replacing one theory for another, or 
        recruit multiple experts for a single case. Multiple 
        entitlement hearings result. According to DOJ, the 
        Government has only appealed one case to the Federal 
        Circuit Court of Appeals since 1995, and also contends 
        that petitioner's experts are numerous.
         If a Court decision is unfavorable, DOJ may 
        repeat arguments during the Damages Hearing that fail 
        during the entitlement phase, thus making the process 
        of awarding due compensation unnecessarily contentious 
        and burdensome.\30\
---------------------------------------------------------------------------
    \30\ Hearing statement by Dr. Marcel Kinsbourne.
---------------------------------------------------------------------------
         Marks v. Sec. HHS has been criticized. ``In 
        the special master's view, [respondent's] counsel's 
        abrasive, tenacious, obstreperous litigation tactics 
        were inappropriate in a program that is intended to be 
        less adversarial; and hindered greatly a fair, 
        expeditious resolution of the case. In addition, 
        counsel lacks simply tact and compassion. Quite 
        frankly; the special master is embarrassed that 
        respondent's counsel and respondent's life care planner 
        represented the United States Government in this 
        case.'' \31\ DOJ claims this case was highly 
        exceptional, and the attorney's conduct was reviewed.
---------------------------------------------------------------------------
    \31\ Decision of Special Master Edwards, Marks v. Sec HHS, p. 15.
---------------------------------------------------------------------------
    Finally, DOJ indicated to the subcommittee that no DOJ 
attorneys handling vaccine injury cases had received formal 
training in Alternative Dispute Resolution [ADR] techniques and 
practices prior to the subcommittee hearing on this topic. 
Since the hearing, DOJ reports that all attorneys assigned to 
vaccine compensation cases have been trained in ADR and that 
efforts are underway to utilize ADR more fully. DOJ also has 
suggested the addition of a Court rule requiring consideration 
of voluntary ADR in all cases.

                           Sovereign Immunity

    The doctrine of sovereign immunity generally prevents the 
Federal Government from being sued without its consent. In 
interpreting legislation, courts may consider whether there has 
been a waiver of immunity with respect to a particular type of 
litigation against the United States.
    One canon of statutory construction is that a waiver of 
sovereign immunity must be definitively and unequivocally 
expressed. A second one is that the statutory language setting 
forth a waiver is to be construed strictly in favor of the 
government. Yet another principle of statutory construction 
regarding remedial or ``welfare'' legislation is that courts 
give a liberal interpretation to further the remedial or 
humanitarian purposes underlying the statute.
    Because the Act authorizes suits and monetary awards 
against the United States, the doctrine of sovereign immunity 
has been interpreted and applied by Special Masters. With 
respect to the Act, which is ``remedial'' in nature and waives 
the Federal Government's immunity from suit, the sovereign 
immunity doctrine has been used to ``trump'' competing remedial 
constructions and provide a rationale for restricting 
compensation awards.\32\
---------------------------------------------------------------------------
    \32\ Decision of Special Master Hastings in Childers v. HHS, pp. 3-
11.
---------------------------------------------------------------------------
    Petitioners' representatives argue that the remedial intent 
of the Act to provide generous compensation should prevail. 
Some argue that the waiver of sovereign immunity is not 
applicable technically since the Secretary simply administers a 
trust funded through a vaccine tax. Some critics of current 
practices have called for an express provision to nullify the 
application of the doctrine of sovereign immunity. The 
committee is concerned that the doctrine should be applied in 
an appropriate manner, consistent with the remedial purposes of 
the Act.

                        Compensation Trust Fund

    Historically, the vaccine injury compensation trust fund 
(the Trust fund) has received more in vaccine excise taxes than 
it has paid out for claims and related administrative costs. 
Because the fund has spent only about $347 million of the $1.37 
billion accrued through fiscal year 1999; the remaining 
approximately $1 billion was loaned to the Treasury and used 
for other Federal programs and activities in exchange for 
Treasury securities. Interest on these securities now totals 
approximately $435 million. The interest in addition to the $1 
billion loaned to the Treasury make up the $1.46 billion 
balance accrued by the end of fiscal year 1999, representing a 
very substantial unused reserve.
    Unless changes in the administration of the Program are 
implemented or new scientific research findings become 
available, this trend of revenue exceeding expenditures could 
continue, while compensation awards are increasingly difficult. 
At current rates, the Congressional Budget Office projects that 
in the next 10 years, the fund will double in size.
    The limited number of compensation awards and growing fund 
balance have become controversial, with various options being 
considered to address the unused funds. Vaccine manufacturers 
view the growing balance as an indicator that the excise tax 
rate is too high and should be lowered. Petitioner families 
cite the fund as evidence of the government's unwillingness to 
compensate vaccine injuries and advocate a less restrictive 
injury table and less burdensome compensation practices. While 
the administration has not articulated a clear position on this 
issue, officials from HHS have considered the fund as a 
potential source of revenue for vaccine-related research or 
surveillance.\33\
---------------------------------------------------------------------------
    \33\ ``Vaccine Injury Trust Fund,'' GAO/HEHS-0067, p. 18.
---------------------------------------------------------------------------
    In the 106th Congress, Representative Ron Lewis (R-KY) 
introduced H.R. 1337, the ``Vaccinate America's Children Now 
Act,'' a bill to amend the Internal Revenue Code of 1986 to 
reduce the tax on vaccines to 25 cents per dose. The bill has 
66 cosponsors, 40 Republicans and 26 Democrats, of which 27 are 
members of the Ways and Means Committee. Senator Bunning (KY) 
introduced the companion bill, S. 85.
    While the trust fund contains a significant sum of money, 
efforts to reduce funding sources raise serious concerns. The 
worldwide vaccine market is estimated soon to top $7 
billion.\34\ In the United States alone, there are currently 
vaccines in development against almost 60 diseases caused by 
bacteria, viruses, fungi and parasites, including AIDS, malaria 
and tuberculosis. Coverage for new vaccines could negatively 
affect the future trust fund balance.\35\
---------------------------------------------------------------------------
    \34\ ``When Vaccines Do Harm to Kids: Autism and More,'' Insight 
Magazine, Feb. 4, 2000, p. 3.
    \35\ ``Commonly Asked Questions About the NVICP,'' HRSA, p. 2.
---------------------------------------------------------------------------
    Similarly, changes in the recommended schedule of 
vaccinations, the increasing use of combination vaccines, and 
the potential for emerging knowledge linking vaccines to 
adverse reactions makes risk assessment increasingly difficult. 
HHS has warned that the fund should not be considered an 
impenetrable reserve of funds.
    Options to control the growth of the trust fund could have 
revenue and spending implications for the overall Federal 
budget. The Budget Enforcement Act of 1990 mandates that 
Congress offset the cost of legislation that reduces revenue or 
increases spending by establishing new or higher taxes 
elsewhere or by decreasing spending for other programs.\36\
---------------------------------------------------------------------------
    \36\ ``Vaccine Injury Compensation Fund,'' GAO report, p. 19.
---------------------------------------------------------------------------

                Vaccine Adverse Events Reporting System

    Typically, vaccine safety studies that are epidemiological 
based make inferences from the absence of specific problems. 
Therefore, it is important to examine and consider surveillance 
and risk management systems and practices.
    While the Vaccine Adverse Events Reporting System [VAERS] 
may be lauded as the ``front line'' of vaccine safety, the lack 
of enforcement provisions and effective monitoring of reporting 
practices preclude accurate assessments of the extent to which 
adverse events are actually reported. Former FDA Commissioner 
David A. Kessler has estimated that VAERS reports currently 
represent only a fraction of the serious adverse events.
    The quality of VAERS data has been questioned. Because 
reports are submitted from a variety of sources, some 
inexperienced in completing data forms for medical studies, 
many reports omit important data and contain obvious errors. 
Assessment is further complicated by the administration of 
multiple vaccines at the same time, following currently 
recommended vaccine schedules, because there may be no 
conclusive way to determine which vaccine or combination of 
vaccines caused the specific adverse event.
    As a database for epidemiological studies, VAERS has 
serious weaknesses. One major problem is that since 
unvaccinated people experiencing adverse events are not 
reported to VAERS, there is no control group to study. Given 
that over 10,000 reports are filed annually, it is difficult to 
assure the accuracy and completeness of the database. IOM 
recognizes that there are limits to the detection and response 
systems currently in use. In a forum convened on this subject, 
they concluded: ``[E]fforts can be made to improve the 
quantity, quality, accessibility, and usefulness of VAERS 
reports.'' \37\
---------------------------------------------------------------------------
    \37\ ``Detecting and Responding to Adverse Events Following 
Vaccination: Workshop Summary,'' by Cynthia J. Howe, Richard B. 
Johnston, and Gerald M. Fenichel, editors, November 1995.
---------------------------------------------------------------------------

                 Conflicting Roles and Responsibilities

    Within Congress, there is bipartisan concern over dual 
responsibilities and potential conflicting interests in HHS 
drug development and delivery. Regarding vaccines, HHS conducts 
and encourages vaccine research on the one hand and is the lead 
agency within the Federal Government for the promotion of 
vaccination programs. HHS also administers the Vaccine Injury 
Compensation Program ([VICP] or the Program). Critics charge 
these responsibilities may conflict.
    Under HHS, the CDC Advisory Committee on Immunization 
Practices [ACIP] makes recommendations for the routine 
administration of vaccines along with schedules regarding 
appropriate periodicity, dosage, and contraindications. The 
ACIP recommends vaccine purchases by CDC. The Food and Drug 
Administration's Vaccine and Related Biological Products 
Advisory Committee [VRBPAC] is responsible for supporting 
applications for licensure of vaccines.
    Because of the importance of preserving the public health 
through the use of safe and effective vaccines, maintaining the 
highest level of integrity over the entire spectrum of vaccine 
development and implementation is critical, and opportunities 
for conflicting roles and interests should be avoided whenever 
possible.

                       IV. Legislative Proposals

                   Proposals Endorsed by HHS and DOJ

    The Advisory Commission on Childhood Vaccines [ACCV] has 
recommended that the HHS Secretary propose changes to the 
Public Health Service Act and the Internal Revenue Code that 
would improve the VICP. One of these proposals, the elimination 
of the requirement that claimants must have incurred non-
reimbursable expenses in excess of $1,000 to file a petition 
for compensation, was signed into law on October 22, 1998. The 
remainder of the recommendations have been incorporated into a 
bill and sent to the Congress for its consideration. These 
include:
         Extend the current statute of limitations from 
        3 years for injury claims and 2 years for death claims, 
        to 6 years for those claiming injury or death resulting 
        from a covered vaccine.
         Allow for the inclusion of family counseling 
        expenses in VICP awards.
         Add a phrase to specifically allow for the 
        inclusion of reasonable fees and costs associated with 
        the establishment of a guardianship or conservatorship 
        in the definition of ``other costs.''
         Allow for an interim payment of costs incurred 
        in adjudicating a post-1988 claim under the VICP after 
        a finding as to entitlement is established. Such an 
        interim payment would be made prior to entry of a final 
        judgment and upon a finding that there was good faith 
        and a reasonable basis for the claim.
         Establish a specific method of calculating 
        lost earnings under VICP.
         Eliminate requirement that ACCV meet at least 
        four times annually.
         Change the rulemaking process for amending the 
        Table by reducing the period for public comment from 
        180 days to 60 days, and eliminating the requirement 
        for a public hearing.
         Clarify the Scope of the term ``Factors 
        Unrelated'' as it applies to determining eligibility 
        and compensation.
         Expand criteria for one of the two reserved 
        general public seats on the ACCV under Section 
        2119(a)(1)(B) of the Public Health Service Act to 
        include individuals who have suffered a vaccine-related 
        injury either as children or as adults.
         Allow the U.S. Court of Federal Claims the 
        discretion to provide for a check for attorneys' fees 
        and costs awarded under section 2115(e) to be made 
        payable solely to the attorney for the petitioner.
         Increase to $10,000,000 the limitation on the 
        amount that may be expended for payment of 
        administrative expenses related to the operation of the 
        VICP from the Vaccine Injury Compensation Trust Fund.
    The following amendment, which the ACCV did not have the 
opportunity to review, was added to the Department's proposed 
bill by the Department of Treasury:
         Allow use of the Vaccine Injury Compensation 
        Trust Fund to pay expenses incurred by the Bureau of 
        the Public Debt in providing financial services to the 
        Trust Fund.

                          Additional Proposals

    Among recently recommended legislative reforms brought to 
the attention of the subcommittee are the following:
    Senator Daschle (D-SD) introduced a bill, S. 992, ``to 
provide technical amendments to the Vaccine Injury Compensation 
Trust Fund.'' The bill repealed certain mutually conflicting 
amendments within Public Law 105-277, ``Omnibus Consolidated 
and Emergency Supplemental Appropriations Act of 1999.'' The 
change eliminates confusion regarding compensability of 
petitions based on certain administrations of any of the three 
vaccines added to coverage under the program in 1997. In 
addition, the bill removes the requirement that at least $1,000 
in non-reimbursable expenses be incurred prior to acceptance of 
the petition for consideration.
    Representative Ron Lewis (R-KY) introduced H.R. 1337, ``a 
bill to amend the Internal Revenue Code of 1986 to reduce the 
tax on vaccines to 25 cents per dose.'' This is identical to 
the bill introduced as H.R. 1337, entitled the ``Vaccinate 
America's Children Now Act.'' This bill has 66 cosponsors, 40 
Republicans and 26 Democrats, of which 27 are members of the 
Ways and Means Committee. Strong support for this proposal also 
was seen in the 105th Congress within the Ways and Means 
Committee and the Senate Finance Committee. Senator Bunning (R-
KY), introduced a companion bill in the Senate, S. 85, with six 
cosponsors and more expected.
    Representative Marcy Kaptur (D-OH) introduced H.R. 1003, 
``a bill to amend the Public Health Service Act to revise the 
filing deadline for certain claims under the National Vaccine 
Injury Compensation Program.'' The language in the bill is the 
same as in the bill she introduced in the 105th Congress as 
H.R. 3778. Her proposal is to amend the criteria defining the 
starting point for the time period in which a petition for 
compensation may be filed. Currently, the timeframe is 36 
months beginning with ``the date of the occurrence of the first 
symptom or manifestation of onset or of the significant 
aggravation of such injury.'' This bill retains the 36-month 
time period, but allows the period to commence on the date a 
diagnosis of vaccine injury is made. Eight other Democrats were 
added as cosponsors.
    Representative Nancy Pelosi (D-CA) introduced H.R. 1274, a 
bill to ``amend the Internal Revenue Code of 1986 to provide a 
credit for medical research related to developing vaccines 
against widespread diseases.'' The ``Lifesaving Vaccine 
Technology Act of 1999'' would provide a tax credit equal to 30 
percent of the qualified vaccine research expenses for the 
taxable year. The vaccine research covered would include 
development of vaccines and microbicides for malaria, 
tuberculosis, HIV, or any infectious disease (of a single 
etiology) which, according to the World Health Organization, 
causes over 1 million human deaths annually. This bill had 
eight cosponsors, all Democrats, including five members of the 
Ways and Means Committee.
    On May 26, Senator Roth (R-DE) introduced S. 1134, the 
``Affordable Education Act of 1999.'' This original measure was 
reported out of the Finance Committee and placed on the Senate 
Legislative Calendar under General Orders. Section 410, 
``Inclusion of Certain Vaccines Against Streptococcus 
Pneumoniae to List of Taxable Vaccines,'' would amend Section 
4132(a)(1) of the Internal Revenue Code by adding a new 
subparagraph as follows: ``(L) Any conjugate vaccine against 
streptococcus pneumoniae.'' The standard excise tax would be 
collected on all sales of such vaccines on the day after the 
date on which the Centers for Disease Control and Prevention 
officially recommends routine administration of this vaccine to 
children. The vaccine has yet to be licensed by the Food and 
Drug Administration.

                       V. Congressional Hearings

                         Subcommittee Hearings

    On May 18, 1999, the Subcommittee on Criminal Justice, Drug 
Policy, and Human Resources held the first of its two hearings 
on vaccines entitled, ``Hepatitis B Vaccine: Helping or Hurting 
Public Health?'' The hearing examined the safety of the 
hepatitis vaccine, the adequacy of disclosure prior to vaccine 
administration and the efficacy of the FDA's Vaccine Adverse 
Event Reporting System. The subcommittee heard testimony from 
Congressman John Joseph Moakley (D-MA) who has experienced 
hepatitis B, and from other individuals and families claiming 
vaccine injuries. Witnesses included: Michael Belkin; Judy 
Converse; Marilyn and Lindsay Kirschner; Barbara Haun; Karen w/ 
PKIDS; and Betty Fluck. Medical experts included: Dr. Sam Katz, 
Infectious Disease Society; Dr. Burton Waisbren, Sr., F.A.C.P.; 
and Dr. Bonnie Dunbar, molecular biologist, Baylor College of 
Medicine. Advocates of vaccine reform included: Thelma Thiel, 
chairman and CEO of the Hepatitis Foundation International; and 
Barbara Loe Fisher, president, National Vaccine Information 
Center. Representing the government were: Harold Margolis, 
Chief, Hepatitis Branch, CDC; and Susan Ellenberg, Director of 
Bio-Statistics and Epidemiology Division, Food and Drug 
Administration.
    On September 28, 1999, the subcommittee convened a hearing 
entitled, ``Compensating Vaccine Injuries: Are Reforms 
Needed?'' The hearing examined the Program's operations 
including: adversarial procedures, evidentiary and adjudicative 
standards, and funding. Testimony was received from: 
petitioners (Michele Clements and Linda Mulhauser); reform 
advocates (John Salamone, president, Informed Parents Against 
VAPP, and Cliff Shoemaker, attorney, Shoemaker & Horn); medical 
experts (Dr. Marcel Kinsbourne, Tufts University, and Dr. 
Arnold Gale, Stanford University); and government witnesses 
(Thomas E. Balbier, Jr., Director, National Vaccine Injury 
Compensation Program, Department of Health and Human Services, 
and John L. Euler, Deputy Director Torts Branch, Civil 
Division, Department of Justice).

           The House Committee on Government Reform Hearings

    The Committee on Government Reform conducted the following 
hearings relative to vaccines, which are not discussed in this 
report:
    ``Vaccines--Finding the Balance Between Public Safety and 
Personal Choice,'' August 3, 1999;
    ``Defense Vaccines: Force Protection or False Security?'' 
October 12, 1999;
    ``Autism--Present Challenges, Future Needs--Why the 
Increased Rates?'' April 6, 2000;
    ``FACA: Conflicts of Interest and Vaccine Development--
Preserving the Integrity of the Process?'' June 15, 2000; and,
    ``Mercury in Medicine--Are We Taking Unnecessary Risks?'' 
July 18, 2000.

                                  
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