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Bill > S2665
US S2665
US S2665A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety.
summary
Introduced
04/12/2018
04/12/2018
In Committee
04/12/2018
04/12/2018
Crossed Over
Passed
Dead
12/31/2018
12/31/2018
Introduced Session
115th Congress
Bill Summary
A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety.
AI Summary
This bill requires the Food and Drug Administration (FDA) to issue guidance within one year on how it will assess evidence to support claims of "opioid sparing" for non-opioid or other non-addictive medical products intended to treat pain. The guidance must cover data collection methodologies, ethical implications of exposing patients to controlled substances in clinical trials, appropriate endpoints to evaluate reduction in opioid use, communication between sponsors and the agency, and the format for submitting data. The bill also requires the FDA to issue guidance within one year on the circumstances under which it will consider misuse and abuse of drugs in making determinations about a drug's safety.
Committee Categories
Health and Social Services
Sponsors (2)
Last Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 04/12/2018)
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/115th-congress/senate-bill/2665/all-info |
| BillText | https://www.congress.gov/115/bills/s2665/BILLS-115s2665is.pdf |
| Bill | https://www.congress.gov/115/bills/s2665/BILLS-115s2665is.pdf.pdf |
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