US Congress House Bill 5334 (Prior Session Legislation)

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Sponsorship: Bipartisan Bill
Status: Introduced on May 7 2012 - 25% progression, died in committee
Action: 2012-05-11 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a drug, to expedite the drug's development and review if: (1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Authorizes the drug's sponsor to request the Secretary to designate the drug as a breakthrough therapy. Requires the Secretary, within 60 days of such request, to determine whether the drug meets such criteria and, if so, make such designation, followed by appropriate actions to expedite its development and review for approval. Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved. Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations. Requires the Comptroller General to assess the manner by which the Food and Drug Administration (FDA) has applied the processes established by this Act and their impact on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions.

To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies.

Rep. Brian Bilbray [R-CA]

Rep. Diana DeGette [D-CO]

Date	Chamber	Action
2012-05-11	House	Referred to the Subcommittee on Health.
2012-05-07	House	Referred to the House Committee on Energy and Commerce.

SB2236 (Related) 2012-03-26 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
HB5651 (Related) 2012-06-04 - Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 420.
SB2516 (Related) 2012-05-07 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 389.
SB3187 (Related) 2012-07-09 - Became Public Law No: 112-144.

Type	Source
Summary	https://www.congress.gov/bill/112th-congress/house-bill/5334/all-info
Text	https://www.congress.gov/112/bills/hr5334/BILLS-112hr5334ih.pdf