S. 2281 (112th): Expanding and Promoting Expertise in Rare Treatments Act of 2012

Introduced:
Mar 29, 2012 (112th Congress, 2011–2013)
Sponsor:
Sen. Sheldon Whitehouse [D-RI]
Status:
Died (Referred to Committee)

The bill’s title was written by the bill’s sponsor. S. stands for Senate bill.

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Status

This bill was introduced on March 29, 2012, in a previous session of Congress, but was not enacted.

Progress
Introduced Mar 29, 2012
Referred to Committee Mar 29, 2012
Cosponsors
1 cosponsors (1I) (show)
Committees

Senate Health, Education, Labor, and Pensions

The committee chair determines whether a bill will move past the committee stage.

Full Title

A bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen the ability of the Food and Drug Administration to seek advice from external experts regarding rare diseases, the burden of rare diseases, and the unmet medical needs of individuals with rare diseases.

Summary

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Text

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Last updated Mar 29, 2012.
5 pages

Primary Source

View on THOMAS (The Library of Congress)

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

3/29/2012--Introduced.
Expanding and Promoting Expertise in Rare Treatments Act of 2012 or EXPERT Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to ensure that opportunities exist for consultation with external experts to promote the efficiency of and inform the review by the Food and Drug Administration (FDA) of drugs and biologic products for rare diseases and drugs and biologic products that are genetically targeted.
Requires the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research to seek the opinion of external experts on topics that may include:
(1) rare diseases;
(2) the severity of rare diseases;
(3) the unmet medical need associated with rare diseases;
(4) the willingness and ability of individuals with a rare disease to participate in clinical trials;
(5) an assessment of the benefits and risks, including side effects, of current and investigational therapies;
(6) the design of clinical trials for rare disease populations and subpopulations; and
(7) demographics and the clinical description of patient populations.
Authorizes:
(1) external experts to request the opportunity to meet with a review division regarding any such topic, and
(2) external experts who are consulted to be considered special government employees.
Declares that nothing in this Act shall be construed to:
(1) create a right for any external expert to obtain access to proprietary information of a sponsor without that sponsor's permission or a legal right for a consultation on any matter, or
(2) require the Secretary to meet with any particular expert.

House Republican Conference Summary

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House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

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