Summary: H.R.5127 — 114th Congress (2015-2016)All Information (Except Text)

There is one summary for H.R.5127. Bill summaries are authored by CRS.

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Introduced in House (04/29/2016)

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.