FDA’s new guidances on Risk Evaluation and Mitigation Strategy (REMS) requirements aims to help generic and biosimilar drugs get to market faster.
“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,” said FDA Commissioner Scott Gottlieb, MD, in a statement.
FDA’s safety programs should not be leveraged “as a way to forestall generic entry” after patent expiration on a brand drug, Gottlieb added. “Our market-based system for rewarding innovation is dependent on this kind of legal competition.”
The Association for Accessible Medicine, made up of generic and biosimilar drug manufacturers, praised the new guidances. “AAM applauds FDA for issuing these guidances to address one form of brand gamesmanship that has delayed generic and biosimilar competition and price reductions for patients,” said Chip Davis, president and CEO of AAM, in a statement. “Calls for voluntary action by brand companies to stop their efforts to thwart generic competition are not enough.”
Davis also urged Congress to pass the CREATES Act, “which will help put an end to these types of abuses and free up the generic and biosimilar competition the President is prioritizing in his ‘American Patients First’ platform.”
The first draft guidance, Development of a Shared System REMS, describes general principles and recommendations to assist sponsors with developing these programs. “The goal is to improve the clarity and efficiency for developing shared system REMS, which will enable timelier market entry for products that are part of these REMS,” Gottlieb said.
The second draft guidance, Waivers of the Single, Shared System REMS Requirement, describes when and how FDA will consider waiving the single, shared system requirement, and how generic applicants can request a waiver.
“Through the new policies that we’re advancing today, our aim is to help generic drug makers get their products through the development and approval processes efficiently while maintaining the safety controls sought by the REMS,” Gottlieb said.