US Congress House Bill 2547 (Prior Session Legislation)

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Spectrum: Partisan Bill (Republican 1-0)
Status: Introduced on May 21 2015 - 25% progression, died in committee
Action: 2015-05-22 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

Surrogate Endpoint Improvement and Utilization Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to allow the sponsor of a drug that is eligible for accelerated approval to request that the Food and Drug Administration (FDA) agree to an accelerated approval development plan that includes a surrogate endpoint for the study of the drug and a magnitude of drug effect that is sufficient to claim the drug is effective. (Accelerated approval is an FDA process for approving a new drug for a serious medical condition at a point in the study of the drug that is reasonably likely to predict a clinical benefit instead of at a later point when a clinical benefit can be confirmed.) The FDA may require the sponsor to modify or terminate an agreed upon plan if additional information indicates that the plan is no longer sufficient to demonstrate the safety and effectiveness of the drug or the drug is no longer eligible for accelerated approval.

Surrogate Endpoint Improvement and Utilization Act of 2015

Rep. Cathy McMorris Rodgers [R-WA]

Date	Chamber	Action
2015-05-22	House	Referred to the Subcommittee on Health.
2015-05-21	House	Referred to the House Committee on Energy and Commerce.
2015-05-21	House	Introduced in House

HB6 (Related) 2015-07-13 - Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/house-bill/2547/all-info
Text	https://www.congress.gov/114/bills/hr2547/BILLS-114hr2547ih.pdf