Bill
Bill > HR7649
US HR7649
US HR7649To direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes.
summary
Introduced
05/03/2022
05/03/2022
In Committee
05/03/2022
05/03/2022
Crossed Over
Passed
Dead
01/03/2023
01/03/2023
Introduced Session
117th Congress
Bill Summary
A BILL To direct the Secretary of Health and Human Services to open a public docket for the submission of public com- ments regarding factors that should be taken into consid- eration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes.
AI Summary
This bill directs the Secretary of Health and Human Services to open a public docket for the submission of comments regarding factors that should be considered when reviewing proposed modifications to an approved Risk Evaluation and Mitigation Strategy (REMS) under the Federal Food, Drug, and Cosmetic Act. The REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns. The bill also requires the Government Accountability Office (GAO) to submit a report to Congress by December 31, 2026, on the number of REMS modifications that have been granted, any issues affecting patient access or provider administration that arose from those modifications, and how such issues were resolved.
Committee Categories
Business and Industry
Sponsors (3)
Last Action
Referred to the House Committee on Energy and Commerce. (on 05/03/2022)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/117th-congress/house-bill/7649/all-info |
| BillText | https://www.congress.gov/117/bills/hr7649/BILLS-117hr7649ih.pdf |
| Bill | https://www.congress.gov/117/bills/hr7649/BILLS-117hr7649ih.pdf.pdf |
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