FDA Commissioner Scott Gottlieb, MD released a statement this week regarding some brand-name drug makers’ use of REMS requirements to block the timely entry of generic drugs to market. Risk Evaluation and Mitigation Strategy (REMS) requirements are required for drugs with serious risks to ensure that the benefits outweigh the risks. “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. […] The other obstacle occurs at the back end, after a generic drug seeks FDA approval and market entry,” Gottlieb stated.
The FDA released two draft guidance documents aimed at helping generic drug makers get their products through the development and approval processes safely and efficiently.