[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1636 Introduced in House (IH)]
114th CONGRESS
1st Session
H. R. 1636
To direct the Secretary of Health and Human Services to conduct or
support a comprehensive study comparing total health outcomes,
including risk of autism, in vaccinated populations in the United
States with such outcomes in unvaccinated populations in the United
States, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 25, 2015
Mr. Posey (for himself and Mrs. Carolyn B. Maloney of New York)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To direct the Secretary of Health and Human Services to conduct or
support a comprehensive study comparing total health outcomes,
including risk of autism, in vaccinated populations in the United
States with such outcomes in unvaccinated populations in the United
States, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Vaccine Safety Study Act''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Securing the health of the Nation's children is our
most important concern as parents and stewards of the Nation's
future.
(2) The Nation's vaccine program has greatly reduced human
suffering from infectious disease by preventing and reducing
the outbreak of vaccine-preventable diseases.
(3) Total health outcomes are the best measure of the
success of any public health effort, including security from
both chronic and infectious disease.
(4) Childhood immunizations are an important tool in
protecting children from infectious disease.
(5) The number of immunizations administered to infants,
pregnant women, children, teenagers, and adults has grown
dramatically over recent years.
(6) The incidence of chronic, unexplained diseases such as
autism, learning disabilities, and other neurological disorders
appears to have increased dramatically in recent years.
(7) Individual vaccines are tested for safety, but little
safety testing has been conducted for interaction effects of
multiple vaccines.
(8) The strategy of aggressive, early childhood
immunization against a large number of infectious diseases has
never been tested in its entirety against alternative
strategies, either for safety or for total health outcomes.
(9) Childhood immunizations are the only health
interventions that are required by States of all citizens in
order to participate in civic society.
(10) Public confidence in the management of public health
can only be maintained if these State government-mandated, mass
vaccination programs--
(A) are tested rigorously and in their entirety
against all reasonable safety concerns; and
(B) are verified in their entirety to produce
superior health outcomes.
(11) There are numerous United States populations in which
a practice of no vaccination is followed and which therefore
provide a natural comparison group for comparing total health
outcomes.
(12) No comparative study of such health outcomes has ever
been conducted.
(13) Given rising concern over the high rates of childhood
neurodevelopmental disorders such as autism and other chronic
conditions, the need for such studies is becoming urgent.
SEC. 3. STUDY ON HEALTH OUTCOMES IN VACCINATED AND UNVACCINATED
AMERICAN POPULATIONS.
(a) In General.--The Secretary of Health and Human Services (in
this Act referred to as the ``Secretary''), acting through the Director
of the National Institutes of Health, shall conduct or support a
comprehensive study--
(1) to compare total health outcomes, including the
incidence and risk of autism, in vaccinated populations in the
United States with such outcomes in unvaccinated populations in
the United States; and
(2) to determine whether exposure to vaccines or vaccine
components is associated with autism spectrum disorders,
chronic conditions, or other neurological conditions.
(b) Rule of Construction.--Nothing in this Act shall be construed
to authorize the conduct or support of any study in which an individual
or population is encouraged or incentivized to remain unvaccinated.
(c) Qualifications.--With respect to each investigator carrying out
the study under this section, the Secretary shall ensure that the
investigator--
(1) is objective;
(2) is qualified to carry out such study, as evidenced by
training experiences and demonstrated skill;
(3) is not currently employed by any Federal, State, or
local public health agency;
(4) is not currently a member of a board, committee, or
other entity responsible for formulating immunization policy on
behalf of any Federal, State, or local public health agency or
any component thereof;
(5) has no history of a strong position on the thimerosal
or vaccine safety controversy; and
(6) is not currently an employee of, or otherwise directly
or indirectly receiving funds from, a pharmaceutical company or
the Centers for Disease Control.
(d) Target Populations.--The Secretary shall seek to include in the
study under this section populations in the United States that have
traditionally remained unvaccinated for religious or other reasons,
which populations may include Old Order Amish, members of clinical
practices (such as the Homefirst practice in Chicago) who choose
alternative medical practices, practitioners of anthroposophic
lifestyles, and others who have chosen not to be vaccinated.
(e) Timing.--Not later than 120 days after the date of the
enactment of this Act, the Secretary shall issue a request for
proposals to conduct the study required by this section. Not later than
120 days after receipt of any such proposal, the Secretary shall
approve or disapprove the proposal. If the Secretary disapproves the
proposal, the Secretary shall provide the applicant involved with a
written explanation of the reasons for the disapproval.
(f) Transparency.--To facilitate further research by the Secretary
or others, the Secretary shall ensure the preservation of all data,
including all data sets, collected or used for purposes of the study
under this section.
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