summary
Introduced
05/21/2015
05/21/2015
In Committee
05/22/2015
05/22/2015
Crossed Over
Passed
Dead
01/03/2017
01/03/2017
Introduced Session
114th Congress
Bill Summary
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.
AI Summary
This bill, the Surrogate Endpoint Improvement and Utilization Act of 2015, amends the Federal Food, Drug, and Cosmetic Act to allow drug sponsors to request an "accelerated approval development plan" from the Food and Drug Administration (FDA). This plan would outline the use of a "surrogate endpoint," which is a measure that is reasonably likely to predict a clinical benefit, as a basis for accelerated approval of a drug for serious conditions. The plan would require agreement on the specific surrogate endpoint, the study design using it, and the magnitude of drug effect on that endpoint that would be sufficient to claim the drug is effective. The FDA can require modifications or termination of this plan if new information suggests it's no longer adequate to demonstrate the drug's safety and effectiveness or if the drug is no longer eligible for accelerated approval, though sponsors would have the opportunity to discuss such decisions.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (1)
Last Action
Referred to the Subcommittee on Health. (on 05/22/2015)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location | Created |
|---|---|---|
| State Bill Page | https://www.congress.gov/bill/114th-congress/house-bill/2547/all-info | 05/22/2015 |
| BillText | https://www.congress.gov/114/bills/hr2547/BILLS-114hr2547ih.pdf | 07/06/2016 |
| Bill | https://www.congress.gov/114/bills/hr2547/BILLS-114hr2547ih.pdf.pdf | 07/06/2016 |
| BillText | http://gpo.gov/fdsys/pkg/BILLS-114hr2547ih/pdf/BILLS-114hr2547ih.pdf | 05/30/2015 |
| Bill | http://gpo.gov/fdsys/pkg/BILLS-114hr2547ih/pdf/BILLS-114hr2547ih.pdf.pdf | 05/30/2015 |
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