114 HR 1636 IH: Vaccine Safety Study Act U.S. House of Representatives 2015-03-25 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 114th CONGRESS 1st Session H. R. 1636 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.

1.

Short title

This Act may be cited as the Vaccine Safety Study Act.

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.

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.