H.R. 5127 · 114th Congress
Curb Opioid Misuse By Advancing Technology Act of 2016
- Stage
- In committee
- Sponsor
- H. Griffith
- Introduced
- 2016-04-29
- Latest action
- 2016-05-06 · Referred to the Subcommittee on Health.
Summary
Curb Opioid Misuse By Advancing Technology Act of 2016
This bill amends the Federal Food, Drug, and Cosmetic Act to extend the marketing exclusivity period for certain brand name drugs that the Food and Drug Administration approves: (1) on the basis of new clinical abuse potential studies, and (2) with labeling that characterizes the drug's abuse-deterrent properties. This extension does not apply to the marketing exclusivity period for new chemical entities.
The bill also extends the marketing exclusivity period for generics of these drugs.