H.R.2025 - Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017115th Congress (2017-2018) |
|Sponsor:||Rep. Griffith, H. Morgan [R-VA-9] (Introduced 04/06/2017)|
|Committees:||House - Energy and Commerce|
|Latest Action:||House - 04/07/2017 Referred to the Subcommittee on Health. (All Actions)|
This bill has the status Introduced
Here are the steps for Status of Legislation:
- Passed House
- Passed Senate
- To President
- Became Law
Summary: H.R.2025 — 115th Congress (2017-2018)All Information (Except Text)
Introduced in House (04/06/2017)
Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act to prevent an application for a new drug from being considered ineligible for approval because its labeling includes information describing abuse-deterrent properties that otherwise would be blocked by market exclusivity provisions.
The Department of Health and Human Services shall issue draft guidance and publish final guidance regarding the award and scope of exclusivity for new drugs with properties designed to deter abuse and the exceptions to such exclusivity.
The bill applies to applications and supplements to applications that are submitted or pending approval on or after January 1, 2017.