Gottlieb Announces Draft REMS Guidance, Calls For End to "Shenanigans"

During yesterday’s Federal Trade Commission public workshop on drug pricing competition, Scott Gottlieb, MD, Commissioner of the FDA, called on drug makers to “end the shenanigans” that delay drug competition in the US marketplace.

Gottlieb’s comment came at the same time as a statement announcing new FDA draft guidance on streamlining the submission and review process for shared-system risk evaluation and mitigation strategies (REMS) programs. While REMS are designed to protect patient safety by providing such materials as medication guides or package inserts (and requiring activities like provider training and patient counseling in some cases), REMS have come under fire as a way that makers of innovator drugs can stave off competition from generics and biosimilars. Because originator product manufacturers and biosimilar or generic drug developers must agree on a single, shared REMS system, REMS programs can potentially be abused to delay the market entry of cheaper drugs.

“Negotiations to reach agreement on shared system REMS can take extended periods of time. This can block the timely entry of a generic competitor,” said Gottlieb. “I believe branded firms sometimes use these negotiations strategically, as a way to slow generic competitors.”

“[We] need to make sure that REMS programs maintain their role in serving public health and don’t become a tool companies can use to delay or block competition from generic products entering the market,” Gottlieb continued, announcing new FDA draft guidance for industry that describes how applicants can submit drug master files, representing all participating firms, to the agency.

The draft guidance, titled “Use of a Drug Master File for Shared System REMS Submissions,” eliminates the need for each manufacturer involved in a REMS process to submit files individually, eliminates duplicative paperwork for drug makers, and streamlines the forms that the FDA’s reviewers must assess. While the new drug master file system is not mandatory, Gottlieb said that “we strongly encourage” its use.

Under the system, only 1 company will be listed as the holder of the master file, and any submission to the file will be assumed to represent the views of all participating REMS applicants. The master file holder must submit a letter of authorization that allows the FDA to review the information in the file in support of REMS applicants.

Among the materials that should be included in the file are the REMS document and materials, the REMS supporting document, REMS assessments and assessment methodologies, REMS correspondence and history, interim versions of documents, responses to the FDA’s requests for information, and file amendments.

Gottlieb also indicated that the FDA will release more information about the circumstances under which it intends to waive the requirement of a single, shared REMS system, including information about how generic drug developers can request waivers.