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The Department of Health and Human Services shall issue draft guidance and publish final guidance regarding the award and scope of exclusivity for new drugs with properties designed to deter abuse and the exceptions to such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.
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