FDA Drug Competition Action Plan | Closing loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition Congress intended
The third component of the Drug Competition Action Plan is aimed at reducing the so-called “gaming” that frustrates and delays generic drug approvals and extends brand monopolies beyond what Congress intended with the Hatch-Waxman Amendments of 1984. Such practices upset the careful balance that Congress sought between product innovation and access and can make the development and approval process unpredictable, and potentially more costly, for generic manufacturers.
To view the guidances listed below, go to Guidances for Drugs and filter by category Drug Competition Action Plan
- Final Guidance for Industry “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” (September 2019; Revised Draft published October 2018)
- Manual of Policies and Procedures (MAPP): Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and Procedures (February 2019)
- Draft Guidance for Industry: Development of a Shared System REMS (June 2018)
- Draft Guidance for Industry: Waivers of the Single, Shared System REMS Requirement (June 2018)
- Draft Guidance for Industry: Use of a Drug Master File for Shared System REMS Submissions (November 2017)
- Public Meeting: Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access (July 2017)