New FDA Guidance Won’t Stop Branded Drugmakers From Delaying Generics


The FDA’s new draft guidance on shared risk evaluation and mitigation strategies (REMS) does little to stop branded drug companies from using REMS to delay generic competition.

The Food and Drug Administration sometimes imposes a REMS on a drug to ensure its benefits outweigh its risks. Ameet Sarpatwari, an instructor at Harvard Medical School, told me the draft guidance “is a helpful step in terms of improving efficiency,” but it doesn’t tackle how brand-name companies are able to use the requirement for a shared REMS to delay generic drugs.

Branded and generic manufacturers of the same product are required to reach agreement on a single, shared REMS system rather than implementing separate REMS. However, branded drug companies sometimes extend these negotiations as a way to slow generic competitors from reaching the market.

The draft guidance describes how branded-drug and generic companies can use a single electronic drug master file for submitting a shared REMS. This is intended to streamline the submission and review process for shared REMS systems. The new process would eliminate duplicative paperwork for sponsors, and would decrease the volume of forms the FDA’s reviewers must access, Food and Drug Administration Commissioner Scott Gottlieb said in an announcement.

Sarpatwari said branded drug companies use a couple of different strategies associated with REMS to delay generics.

One is the branded drug company delays generic entry through the shared REMS requirement. Another is that companies use REMS to delay generic drug launches by refusing to provide generic companies with drug samples needed for bioequivalence testing, Sarpatwari said.

Deborah Shelton, a pharmaceutical law attorney, told me the draft guidance “is not likely to have a significant effect on resolving issues of use of REMS to impede generic and biosimilars access” to branded drug samples. Biosimilars are less expensive versions of biologic drugs.

Shelton is with McCarter & English in Washington, and a Bloomberg Law advisory board member.

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