PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the Subcommittee on Health.
Congressional Research Service
Version 00 · Introduced in House · May 21, 2015
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.
People & committees
Rep. McMorris Rodgers, Cathy [R-WA-5] · R–WA
Legislative record
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Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Aug 12, 2025. Consult Congress.gov for the current record.
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