Bill Addresses 3-year Exclusivity on Abuse-deterrent Properties

Rep. Morgan Griffith (R-VA) has introduced H.R. 2025, the “Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017, a bill to prevent certain drug applications from being considered ineligible for approval on the basis that the proposed labeling includes information describing abuse-deterrent properties that otherwise would be blocked by exclusivity provisions.

The bill addresses a controversy brought on by FDA’s interpretation of the scope of three-year new clinical investigation exclusivity as it applies to subsequent 505(b)(2) NDA applicants in the context of abuse-deterrence drug products, according to FDALawBlog.com. “FDA interprets the exclusivity to apply to a particular route of abuse instead of to a particular abuse-deterrent formulation,” the blog says.

The measure would also require the agency to issue guidance on the award and scope of three-year exclusivity for abuse-deterrent drug product formulations.