1.Short title; table of
contents
(a)This Act may be cited as the Vaccine Safety and Public Confidence Assurance Act of
2009
.
(b)The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Establishment of Agency for Vaccine Safety
Evaluation.
2.The Congress finds as follows:
(1)The Nation’s
vaccine program has greatly reduced human suffering from infectious disease by
preventing and reducing the outbreak of vaccine-preventable diseases.
(2)The prestigious
scientific journal Nature has noted that to maintain public confidence in
vaccines “there is a strong case for a well-resourced independent agency that
commends the trust of both the government and the public”. Nature 439,
1–2.
(3)Public confidence
in governmental vaccine-safety monitoring agencies is critical to building and
maintaining public confidence in vaccine safety.
(4)Actual or
perceived conflicts of interest undermine the credibility of vaccine-safety
assurances and reports issued by those with conflicts of interest.
(5)The Federal
Government has a responsibility to take all steps feasible to ensure that
research evaluating the safety of existing and future vaccines is of the
highest quality and free from conflicts of interest.
(6)The Centers for
Disease Control and Prevention is responsible for promoting both high
immunization rates and vaccine safety, duties perceived by some to constitute a
conflict of interest.
(7)The actual or perceived conflict of
interest between vaccine promotion and vaccine safety has been compounded by
the fact that vaccine-safety programs and the National Immunization Program
have needed to compete against each other for funds. Funding for vaccine-safety
research should be completely independent from other vaccine-related budget
priorities.
(8)There are numerous
vaccines presently in the development pipeline for disease prevention and
treatment, and it is critical that the Nation develop longer term and more
specific safety monitoring mechanisms.
(9)It is critical
that the Federal Government revamp vaccine-safety monitoring programs to focus
increasingly on developing prevaccination screening tools to prevent injury,
thereby raising public confidence and reducing vaccine injuries.
(10)The current structure for monitoring for
vaccine safety, postlicensure, primarily focuses on epidemiology. There is
inadequate funding directed toward independent research, including research
directed at understanding underlying biological mechanisms and biological
susceptibilities and designed to understand why some children and adults
develop serious adverse outcomes after vaccination.
(11)Because most
serious adverse reactions to vaccines are rare, epidemiology studies may be
limited in their ability to establish or rule out causal association or
biological plausibility.
(12)The
vaccine-safety monitoring functions of the Department of Health and Human
Services have tended to focus on monitoring for acute adverse events rather
than chronic adverse events. There is little coordination and inadequate effort
to investigate the biological mechanisms underlying vaccine-related adverse
events.
3.The purpose of this Act is to direct that
vaccine safety monitoring and research focus on active surveillance,
researching biological mechanisms for acute and chronic adverse events
following vaccination, developing prevaccination screening methods within a
framework that is free from actual and perceived biases, and developing a
vaccine safety research agenda.
4.Establishment of
Agency for Vaccine Safety EvaluationTitle XXI of the Public Health Service Act
(42 U.S.C. 300aa–1 et seq.) is amended by adding at the end the
following:
3Agency for Vaccine
Safety Evaluation
2141.There is established in the Office of the
Secretary the Agency for Vaccine Safety Evaluation, to be headed by the
Director for Vaccine Safety Evaluation.
2142.
(a)With respect to
vaccines, the Director for Vaccine Safety Evaluation—
(1)shall conduct or
support safety research, including research on—
(A)acute and chronic
adverse reactions, including with respect to subpopulations;
(B)components of
vaccines, including additives, adjuvants, and preservatives;
(C)delivery
mechanisms; and
(D)the potential
presence of adventitious agents in vaccines; and
(2)shall conduct or
support long- and short-term monitoring of vaccines for which a biologics
license is in effect under section 351 of the Public Health Service Act;
(3)shall develop a
vaccine safety research agenda;
(4)shall conduct or
support research across a range of disciplines, including molecular genetics,
toxicology, pharmacokinetics, cell biology, neurology, immunology,
pharmacogenomics, virology, and epidemiology;
(5)shall conduct or
support research to address issues raised in claims of injury brought before
the Secretary, the Attorney General of the United States, and State and Federal
courts;
(6)shall develop,
evaluate, and test hypotheses, when appropriate, about potential adverse
reactions, including those generated by the Department of Defense, the National
Institutes of Health, the Centers for Disease Control and Prevention, the Food
and Drug Administration, the Health Resources and Services Administration,
other governmental agencies, and external researchers;
(7)shall, on a
regular basis, evaluate, report on, and explore means to promote the compliance
of health care providers and vaccine manufacturers with Federal requirements
for reporting adverse reactions related to licensed vaccines, including the
requirements of section 2125(b);
(8)shall conduct or
support research to evaluate reports of injury following vaccine administration
for the purpose of developing tests to prescreen individuals and subpopulations
at greater risk of injury;
(9)shall conduct or
support research to evaluate biological mechanisms of injury for the purpose of
eliminating or reducing the risk of such injury through better prescreening
tools or through modification of vaccines;
(10)shall conduct
long-term monitoring of new or altered vaccines, including by monitoring the
effects of changes to the recommended childhood and adolescent immunization
schedule of the Centers for Disease Control and Prevention; and
(11)shall provide, in
conjunction with the National Library of Medicine, a clearinghouse for
prelicensure and postlicensure studies of vaccines and make such clearinghouse
publicly accessible by means of the Internet.
(b)In
carrying out this subtitle, the Director for Vaccine Safety Evaluation—
(1)may not employ any individual as an officer
or employee in a position in level I, II, III, IV, or V of the Executive
Schedule or level GS–15 of the General Schedule if the individual has been
employed within the preceding 5 years—
(A)by the Centers for Disease Control and
Prevention or the Food and Drug Administration to carry out any function
relating to monitoring, or research on, adverse reactions related to a licensed
vaccine or any function related to vaccine development;
(B)by the National
Institutes of Health to carry out any function relating to vaccine development;
or
(C)by a vaccine
manufacturer; and
(2)shall ensure that all personnel assigned to
carry out functions relating to vaccine monitoring or research on adverse
reactions related to vaccines do not have any related professional, familial,
or financial conflict of interest.
(c)In awarding any
grant relating to research on adverse reactions to vaccines, the Director for
Vaccine Safety Evaluation—
(1)shall require
applicants to disclose (and update every 6 months) all potential conflicts of
interest;
(2)shall provide all disclosures under
paragraph (1) to the advisory council for consideration as part of the
council’s review of the application for the grant; and
(3)shall ensure that
the applicant for the grant does not have—
(A)any financial
conflict of interest that might compromise the research findings, such as
holding a related patent or having a family member who holds a related patent;
or
(B)any conflict of
interest resulting from the applicant’s association with an entity with direct
or indirect financial interest in the outcomes of vaccine-safety research, such
as receiving money or an in-kind contribution from a manufacturer of the
particular vaccine or vaccine components to be investigated pursuant to the
grant.
(d)Vaccine Safety
Datalink Project
(1)The Director for Vaccine Safety Evaluation shall have the
responsibility for maintaining access to and overseeing the Vaccine Safety
Datalink Project (and any successor vaccine database).
(2)The Director for
Vaccine Safety Evaluation—
(A)shall ensure that the Director of the
Centers for Disease Control and Prevention and the Commissioner of Food and
Drugs have access to the Vaccine Safety Datalink Project to the full extent
necessary to conduct or support monitoring, or research on, acute adverse
reactions related to any licensed vaccine; and
(B)shall consider any
comments or recommendations of the Director of the Centers for Disease Control
and Prevention and the Commissioner of Food and Drugs regarding the Vaccine
Safety Datalink Project.
(3)In carrying out this subsection, the
Director for Vaccine Safety Evaluation—
(A)shall facilitate
external access to the Vaccine Safety Datalink Project for purposes of
research, including by—
(i)requiring each participating health care
provider or health maintenance organization to use a facilitator and sufficient
staff for the purpose of assisting external researchers in navigating the data
collection systems of the provider or organization;
(ii)at
the discretion of the Director, reimbursing the provider or organization for
the salaries of such facilitator and staff and any other expenses incurred for
such purpose;
(iii)allowing
researchers to access data that is collected through the Vaccine Safety
Datalink Project, or published after derivation from data that is so collected,
for review and duplication;
(iv)requiring a
researcher seeking such access to demonstrate, for the proposed research, the
approval of not more than one institutional review board—
(I)from not more than
one participating health care provider or health maintenance organization;
or
(II)established by
the Secretary or an agency of the Department of Health and Human Services;
and
(v)developing
guidelines for data sharing, including guidelines for making publicly
accessible—
(I)a clarification of
the types of studies possible with the Vaccine Safety Datalink Project;
(II)a categorization
of the types of studies possible with the Vaccine Safety Datalink Project;
and
(III)a delineation of
the skills necessary to work with the Vaccine Safety Datalink Project;
and
(B)in carrying out
subparagraph (A), may deny access to the Vaccine Safety Datalink Project for
purposes of research that is not conducted or supported by the Agency only if
the Director for Vaccine Safety Evaluation determines that—
(i)the research is not technically feasible
because—
(I)the requested data
are not available in the database;
(II)enough
individuals are not represented in the database with the exposures and outcomes
of interest to study the proposed hypothesis; or
(III)the proposed
statistical tests are not possible with the available data; or
(ii)the researchers
fail to demonstrate core competencies in the basic skills needed to analyze the
relevant data;
(C)shall provide for
transparency, including by—
(i)making publicly
available the results of studies conducted through the Vaccine Safety Datalink
Project; and
(ii)maintaining
archives of data sets in the Vaccine Safety Datalink Project for not less than
7 years;
(D)shall ensure that, when external
researchers access data that is collected through the Vaccine Safety Datalink
Project, individually identifiable information is removed to the extent
necessary to preserve patient confidentiality; and
(E)may take such other
actions and impose such requirements as the Director for Vaccine Safety
Evaluation deems necessary to facilitate external or public access to the
database without compromising patient confidentiality.
(e)Review of
international activitiesNot later than 18 months after the date
of the enactment of this subtitle, the Director for Vaccine Safety Evaluation
shall—
(1)complete a
thorough review of all functions transferred to the Agency under section 2144
relating to international agreements, partnerships, and activities in which the
United States Government has a fiduciary role, identify any related conflicts
of interest, and develop and implement a plan to reduce such conflicts to the
extent possible; and
(2)submit a report to
the Congress containing the results of the review conducted under paragraph
(1), describing the conflicts of interests identified under such paragraph, and
including the plan developed under such paragraph.
(f)
(1)The
Director for Vaccine Safety Evaluation may establish a program of awarding
fellowships to individuals for research on vaccine safety.
(2)The
Director for Vaccine Safety Evaluation may not award a fellowship to an
individual for research under this subsection unless the individual
agrees—
(A)to refrain from
accepting any payment or other benefit for such research from a manufacturer of
a vaccine or vaccine component to be subject to the research;
(B)to refrain from
employment by, or acceptance of payment from, a vaccine manufacturer or any
organization that receives substantial funding from a vaccine manufacturer
before the date that is 2 years after the end of such research; and
(C)to disclose (and update every 6 months) all
potential conflicts of interest.
(3)To
seek a fellowship under this subsection, an individual shall submit to the
Director for Vaccine Safety Evaluation an application in such form, in such
manner, and containing such information as the Director for Vaccine Safety
Evaluation may reasonably require.
(4)The Director for
Vaccine Safety Evaluation shall establish peer review mechanisms to evaluate
applications for fellowships under this subsection.
(g)
(1)The requirements of section 492 (relating to peer review)
shall apply to research and development conducted or supported by the Agency in
the same manner and the to same extent as such requirements apply to research
and development conducted or supported by the National Institutes of
Health.
(2)Technical and
scientific peer review groupsThe Director for Vaccine Safety
Evaluation may, without regard to the provisions of title 5, United States
Code, governing appointments in the competitive service, and without regard to
the provisions of chapter 51 and subchapter III of chapter 53 of such title
relating to classification and General Schedule pay rates, establish such
technical and scientific peer review groups as are needed to carry out the
requirements of this subtitle and appoint and pay the members of such groups,
except that officers and employees of the United States shall not receive
additional compensation for service as members of such groups.
(h)At the request of the Director for Vaccine Safety
Evaluation, the Commissioner of Food and Drugs shall provide the Director with
complete access to all vaccine-related information submitted to the Food and
Drug Administration by vaccine manufacturers, irrespective of whether the
information was submitted before or after approval of the vaccine under section
351. The Director shall keep such information confidential to the same extent
as the Commissioner of Food and Drugs is required to keep such information
confidential, and the Director shall not disclose such information under
section 552 of title 5, United States Code.
(i)
(1)Not
less than twice each year, the Director for Vaccine Safety Evaluation shall
submit a report on the Agency’s activities under this section to the Advisory
Committee on Immunization Practices, the National Vaccine Advisory Committee,
the National Vaccine Program Office, the National Vaccine Injury Compensation
Program, the Health Resources and Services Administration, and any other entity
deemed appropriate by the Director or by the Secretary of Health and Human
Services.
(2)The Director for Vaccine Safety Evaluation shall
make each report under this subsection publicly available.
2143.Postmarketing
vaccine safety
(a)Surveillance and
clinical trials
(1)The Director for Vaccine Safety Evaluation, in
consultation with the Commissioner of Food and Drugs, shall require the
manufacturer of each covered vaccine to provide for postmarketing surveillance
and clinical testing for any acute or chronic adverse reactions associated with
the vaccine.
(2)The
Director for Vaccine Safety Evaluation shall require the following:
(A)Postmarketing
surveillance and clinical testing under paragraph (1) shall be
conducted—
(i)by
one or more individuals referred to the advisory council by the manufacturer or
by the Agency, recommended by the advisory council under section 2145(b)(3),
and approved by the Director for Vaccine Safety Evaluation under paragraph (3);
and
(ii)in accordance
with a research protocol referred to the advisory council by the manufacturer
or by the Agency, recommended by the advisory council under section 2145(b)(3),
and approved by the Director for Vaccine Safety Evaluation.
(B)The data and
analysis of postmarketing surveillance and clinical testing under paragraph (1)
shall be made available for objective, independent evaluation.
(3)The Director for Vaccine Safety Evaluation may not
approve an individual for the purpose of conducting postmarketing surveillance
or clinical testing under paragraph (1) unless the individual demonstrates to
the Director’s satisfaction that the individual has no present conflict of
interest that might compromise such surveillance or testing, including any
employment or financial relationship with a vaccine manufacturer.
(4)For
purposes of this subsection, the term covered vaccine means a
vaccine licensed under section 351 after January 1, 2009.
(b)Relation to CDC,
FDA, and VAERSThis subtitle shall not be construed to diminish
the authority of the Director of the Centers for Disease Control and Prevention
or the Commissioner of Food and Drugs to implement the Vaccine Adverse Event
Reporting System. The postmarketing surveillance conducted by the Director for
Vaccine Safety Evaluation under this section shall be in addition to the
postmarkeing surveillance conducted under the Vaccine Adverse Event Reporting
System.
(c)Recommendations
on vaccine safety
(1)If more than 1 vaccine is licensed under
section 351 for the purpose of preventing or mitigating the effects of the same
disease, the Director for Vaccine Safety Evaluation may award grants to conduct
comparative studies to determine, for each such vaccine, whether the vaccine is
associated with fewer acute or chronic serious adverse reactions (in the
population as a whole or in any subpopulation) than any other vaccine licensed
for the purpose of preventing or mitigating the effects of the same disease.
Such studies may focus on administering vaccines in isolation or in combination
with other vaccines.
(2)If
the Director for Vaccine Safety Evaluation determines that a vaccine described
in paragraph (1) is associated with fewer acute or chronic adverse reactions
(in the population as a whole or in any subpopulation) than another vaccine
licensed for the purpose of preventing or mitigating the effects of the same
disease, the Director shall make this determination publicly available.
(d)Registration of
clinical trials
(1)The
Director for Vaccine Safety Evaluation shall require the manufacturer of a
vaccine that is licensed under section 351, or for which the manufacturer will
seek licensure under section 351, to register in a qualified public registry
each clinical trial conducted or supported by the manufacturer with respect to
the vaccine, irrespective of whether such trial is suspended before
completion.
(2)In carrying out subsection (a), the Director for
Vaccine Safety Evaluation shall require the manufacturer to include in the
registration for each clinical trial the following information:
(A)A unique
identifying number.
(B)A statement of each
intervention and comparison studied.
(C)A statement of the
study hypothesis.
(D)Definitions of the
primary and secondary outcome measures.
(E)Eligibility
criteria.
(F)Key trial dates
(including the registration date, the anticipated or actual start date, the
anticipated or actual date of last follow-up, the planned or actual date of
closure to data entry, and the date on which trial data is considered to be
complete).
(G)The target number
of subjects.
(H)The funding
source.
(I)Contact
information for the principal investigator.
(J)Such other
information as the Director may require.
(3)In carrying out subsection (a), the Director for
Vaccine Safety Evaluation shall require the manufacturer to register each
clinical trial—
(A)if the trial starts
on or after the date of the enactment of this section, not later than the onset
of patient enrollment; and
(B)if the trial
starts before the date of the enactment of this section, not later than the end
of the 90-day period following such date of enactment.
(4)In
this subsection:
(A)The term
clinical trial means a research project that prospectively assigns
human subjects to intervention or comparison groups to study the
cause-and-effect relationship between a medical intervention and a health
outcome.
(B)The term
qualified public registry means a registry that—
(i)is accessible to
the public at no charge;
(ii)is open to all
prospective registrants;
(iii)is managed by a
nonprofit organization or a Federal, State, or local governmental
entity;
(iv)has in effect a
mechanism to ensure the validity of the registration data;
(v)is electronically
searchable; and
(vi)includes, for each
clinical trial, each category of information described in paragraph (2).
(5)This
subsection applies only with respect to clinical trials that are ongoing on, or
start on or after, July 1, 2009.
2144.Transfer of CDC
functions relating to monitoring adverse reactions related to licensed
vaccines
(a)Transfer of CDC
functionsEffective on the date that is 1 year after the date of
the enactment of this subtitle, there are transferred to the Agency all the
functions, assets, and obligations of the Centers for Disease Control and
Prevention relating to—
(1)the Vaccine Safety
Datalink Project;
(2)the Clinical
Immunization Safety Assessment Centers; or
(3)any other
post-licensure vaccine safety monitoring activities.
(b)The Secretary of Health and Human Services shall take
such steps as are necessary to ensure the orderly transfer under this section
of functions, assets, and obligations from the Centers for Disease Control and
Prevention.
(c)Except with respect to the activities specified in
subsection (a), nothing in this subtitle shall be construed to transfer or
limit the authority of the Director of the Centers for Disease Control and
Prevention to conduct surveillance and response activities with respect to
vaccine safety or effectiveness, including with respect to acute adverse
reactions.
2145.
(a)The
Secretary shall establish in the Agency an advisory council.
(b)The
advisory council shall—
(1)formulate
recommendations on the need for new or improved research on licensed
vaccines;
(2)develop and
annually update a vaccine safety research agenda;
(3)recommend
individuals and research protocols for purposes of section
2143(a)(2)(A);
(4)if potentially
vaccine-related toxicological damage or subacute infection is observed in
vitro, in laboratory animals, or in clinical testing, formulate recommendations
on conducting laboratory and clinical research even in the absence of
epidemiological evidence;
(5)not later than 2
weeks after each quarterly meeting of the advisory council, submit to the
Agency a report that includes a summary of the presentations made at the
meeting, a list of hypotheses proposed, and the recommendations of the advisory
council on research described in paragraph (1);
(6)review each
application submitted to the Director for Vaccine Safety Evaluation for a grant
or other assistance related to vaccine research;
(7)make
recommendations to the Director for Vaccine Safety Evaluation regarding each
such application;
(8)make
recommendations to the Secretary of Health and Human Services regarding vaccine
safety;
(9)not less than
quarterly, submit a report to the Secretary of Health and Human Services
regarding vaccine safety efforts; and
(10)make publicly
available—
(A)each report
submitted under paragraph (9); and
(B)a transcript of
each meeting of the advisory council.
(c)Effect of
recommendationsThe Director for Vaccine Safety Evaluation may
not approve any application for a grant or other assistance related to vaccine
research until the Director has considered the recommendations of the advisory
council regarding such research. If the Director decides to approve or
disapprove any such application contrary to the recommendations of the advisory
council, the Director shall provide the advisory council with, and make
publicly available, a detailed, written explanation of the reasons for the
decision.
(d)
(1)The
advisory council shall be composed of 18 members appointed by the Secretary,
including the following:
(A)Not more than 2
representatives of the vaccine manufacturing industry.
(B)One practicing
pediatrician.
(C)One infectious
disease expert.
(D)Five adults who
are each—
(i)a
victim of a vaccine injury; or
(ii)a
parent of the victim of a vaccine-related injury.
(E)One representative
of the general public who—
(i)is
not the victim of a vaccine injury; and
(ii)does not have a
conflict of interest described in paragraph (1)(A), (1)(B), or (2) of section
2142(b).
(F)One
toxicologist.
(G)One
neurologist.
(H)One
geneticist.
(I)One
immunologist.
(J)One State or local
public health officer.
(K)Not less than 4
and not more than 6 additional representatives.
(2)In
appointing the members of the Commission, the Secretary shall ensure that not
less than one-third of the members of the advisory council are selected from
among individuals who have a vaccine-related injury or who have an immediate
family member with a vaccine-related injury (irrespective of whether there is a
judicial or administration finding of such injury).
(3)In appointing the
members of the Commission, the Secretary shall ensure that such members do not
have any related financial conflict of interest. For purposes of this
paragraph, the Secretary shall not treat as a conflict of interest the
following:
(A)In the case of a
member appointed under paragraph (1)(A) who is employed in the vaccine
manufacturing industry, the receipt of a salary or other benefits for such
employment.
(B)In the case of 2
of the members appointed under paragraph (1)(D), any pending claim for
compensation for a vaccine-related injury.
2146.The Director for
Vaccine Safety Evaluation shall designate an employee of the Agency to serve as
a full-time liaison between the Agency and the Department of Defense, the
National Institutes of Health, the Food and Drug Administration, and the
Centers for Disease Control and Prevention, and any other agency as the
Director determines necessary.
2147.In this subtitle:
(1)The term
advisory council means the advisory council established pursuant
to section 2145.
(2)The term
Agency means the Agency for Vaccine Safety Evaluation.
(3)The term
assets includes contracts, facilities, property, records,
unobligated or unexpended balances of appropriations, and other funds or
resources (other than personnel).
(4)The term
functions includes authorities, powers, rights, privileges,
immunities, programs, projects, activities, duties, and
responsibilities.
(5)The term
licensed vaccine means a vaccine with a biologics license in
effect under section 351 of the Public Health Service Act (42 U.S.C.
262).
(6)The term
personnel means officers and employees.
(7)The term
Project means the Vaccine Safety Datalink Project.
2148.Authorization of
appropriationsThere is
authorized to be appropriated—
(1)for conducting and
supporting research under this subtitle, $80,000,000 for fiscal year 2010;
and
(2)for carrying out
responsibilities under this subtitle other than the conduct or support of
research, such sums as may be necessary for fiscal year
2010.
.