US Congress House Bill 4156 (Prior Session Legislation)

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Spectrum: Bipartisan Bill
Status: Introduced on March 7 2012 - 25% progression, died in committee
Action: 2012-03-09 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 or EXPERRT Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to establish a program for consultation with external experts to inform and strengthen the Food and Drug Administration's (FDA's) review of drugs and biologic products for rare diseases and drugs and biologic products that are genetically targeted. Requires, under such program, each review division within 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. Allows external experts to request the opportunity to meet with a review division regarding any such topic. Authorizes the Secretary to determine the timing of each consultation, which may occur prior to, or following, the filing of an investigational new drug application, a new drug application, or a biologies license application. Requires the experts consulted to be considered special government employees.

Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012

Sen. Edward Markey [D-MA]	Rep. Spencer Bachus [R-AL]	Sen. Bill Cassidy [R-LA]	Rep. Kathy Castor [D-FL]
Rep. Howard Coble [R-NC]	Rep. Charles Dent [R-PA]	Rep. Michael Doyle [D-PA]	Rep. Bob Filner [D-CA]
Rep. John Fleming [R-LA]	Rep. Peter King [R-NY]	Rep. Zoe Lofgren [D-CA]	Rep. Tom Marino [R-PA]
Rep. James McGovern [D-MA]	Rep. Mick Mulvaney [R-SC]	Rep. Tim Murphy [R-PA]	Rep. Sue Myrick [R-NC]
Rep. Bill Pascrell [D-NJ]	Rep. Ed Pastor [D-AZ]	Rep. Cliff Stearns [R-FL]	Rep. Paul Tonko [D-NY]
Rep. Greg Walden [R-OR]	Sen. Peter Welch [D-VT]	Rep. Frank Wolf [R-VA]

Date	Chamber	Action
2012-03-09	House	Referred to the Subcommittee on Health.
2012-03-07	House	Referred to the House Committee on Energy and Commerce.

SB2281 (Related) 2012-03-29 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/112th-congress/house-bill/4156/all-info
Text	https://www.congress.gov/112/bills/hr4156/BILLS-112hr4156ih.pdf