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# Bill Addresses 3-year Exclusivity on Abuse-deterrent Properties
- URL: https://www.fdaweb.com/bill-addresses-3-year-exclusivity-on-abuse-deterrent-properties/
- Published: 2017-04-10T12:00:00.000Z
- Updated: 2026-09-14T22:16:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138410

Rep. **Morgan Griffith** (R-VA) has introduced [H.R. 2025,](https://www.congress.gov/bill/115th-congress/house-bill/2025?ref=fdaweb.com) the “[Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017](http://www.fdalawblog.net/abuse-deterrent%5F03%5Fxml.pdf?ref=fdaweb.com), 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*](http://www.fdalawblog.net/fda%5Flaw%5Fblog%5Fhyman%5Fphelps/2017/04/griffith-bill-proposes-legislative-fix-to-route-of-abuse-exclusivity-block.html?ref=fdaweb.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.