FDA releases new guidance on REMS programs used to block generic competition and access

FDA Commissioner Scott Gottlieb, MD, released Thursday a statement regarding some brand-name drug makers' use of Risk Evaluation and Mitigation Strategy (REMS) requirements to block generic drugs from making a timely entry to market.

FDA Commissioner Scott Gottlieb, MD, released Thursday a statement regarding some brand-name drug makers' use of Risk Evaluation and Mitigation Strategy (REMS) requirements to block generic drugs from making a timely entry to market. Gottlieb explained that REMS requirements have been exploited in the front end of the drug development process as well as at the back end. "On the front end, brand drug makers sometimes use REMS as a way to restrict the sale of their drugs, keeping the drug out of the hands of generic firms," Gottlieb said. He noted, "The other obstacle occurs at the back end, after a generic drug seeks FDA approval and market entry." Gottlieb said negotiations on a shared system REMS between a brand and generic drug company "can extend for long periods of time," which can delay the market entry of a generic drug. The <a href="https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma…; target="_blank">first draft guidance</a> FDA is issuing today describes general principles and recommendations to help sponsors with developing these program, with the objective of improving the clarity and efficiency for developing shared system REMS. The <a href="https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma…; target="_blank">second draft guidance</a> describes when and how FDA will consider waiving the single, share system requirement, and how generic applicants can request a waiver. "We believe that by making the process for developing a shared system REMS more efficient, we'll discourage brand drug makers from using REMS as a way to block generic entry and help end some of the tactics that can delay access," Gottlieb said.