FDA Announces New Draft REMS Guidance

Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all manufacturers of the same drug, which eliminates duplicative paperwork.

This draft guidance is part of the FDA’s new two-pronged approach to address REMS issues. The FDA aims to “encourage the use of shared system REMS between all innovator and generic companies” and to “reduce the likelihood that branded drug companies can use the existence of REMS as a way to slow the entry of generic competition.” At a later date, the FDA plans to provide information on waiving the shared system REMS requirement altogether. Waivers would prevent branded sponsors from using REMS negotiations to slow generic entry.

Comments on the draft guidance are due by January 8, 2018.

Big Molecule Watch will continue to track regulatory developments that impact biosimilars, so check back for the latest news.