On November 8, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb spoke as a keynote speaker at the Federal Trade Commission (“FTC”) workshop, Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics (“Workshop”) and called to “end the shenanigans” that can delay or restrict generic drug competition.
Gottlieb discussed his concern for prolonged negotiations over terms of shared Risk Evaluation and Mitigation Strategies (“REMS”)—that regulators often require in order to restrict the distribution of potentially dangerous medicines—and other tactics that prevent generic companies from purchasing drug products to run bioequivalence or bioavailability studies necessary for approval. He further criticized these tactics as “unfair and exploitive practices,” and to conflict with “broader public health goals.”
In response, Gottlieb said FDA is making it easier for sponsors of innovative drugs to cooperate with generic companies to implement a common master file for the implementation of REMS. FDA’s “goal is to see sponsors share REMS systems to reduce burdens on providers, ” but when these negotiations are drawn out FDA is going to be in a better position to deter such practices. If companies fail to agree on terms of shared REMS, FDA will “have a stronger basis to issue a waiver that will allow the generic drug makers to go their own way if they have to, and develop their own REMS,” Gottlieb said at the Workshop. This REMS master file is the beginning of FDA’s attempts to make it easier to implement single shared REMS.
The Workshop coincided with FDA’s November 8, 2017 release of new draft guidance called, “Use of a Drug Master File for Shared System REMS Submissions,” to further streamline the submission and review process for shared system REMS, which are those that include more than one medication. Currently, under a shared system REMS, multiple applicants need to coordinate the submission of identical REMS-related documents for their respective applications. This draft guidance explains FDA’s current position that the use of a single Drug Master File for shared system REMS submissions will allow manufacturers with products in shared system REMS programs to submit to the agency one collective set of files. Gottlieb noted that he hopes this new REMS document template will streamline the drafting and review of shared REMS.
Comments on the draft guidance are due on January 8, 2018, before FDA begins work on the final version of the guidance. Stakeholders should submit comments to FDA before this deadline in order to weigh in the agency’s strategies. The Health Law Pulse will continue to monitor developments regarding FDA’s treatment of REMS and the relevant guidance.
Special thanks to Robert Kantrowitz* for his assistance in drafting this post.
*Law Clerk–not admitted to practice law.