FDA Releases REMS Guidance

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The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.

On May 31, 2018, FDA Commissioner Scott Gottlieb, MD, announced the publication of two guidance documents issued to help foster generic-drug development while also ensuring the adherence to Risk Evaluation and Mitigation Strategy (REMS) requirements. REMS are used to ensure that the benefits of the drug outweigh its risks. Brand drug makers have been accused of using these requirements to limit generic-drug makers’ access to product, which they need to develop generic versions of branded drugs.

“We have seen REMS requirements be exploited in two ways. One occurs at the front end of the drug development process, when generic drugs are being developed. The other occurs at the back end of the process, after necessary testing has been completed, when a generic drug seeks approval and market entry,” Gottlieb said in a statement.

The guidance document, Development of a Shared System REMS, provides general principles and recommendations to assist sponsors with developing REMS programs. FDA hopes the guidance will help “improve the clarity and efficiency for developing shared system REMS, which will enable timelier market entry for products that are part of these REMS.”

Waivers of the Single, Shared System REMS Requirement gives information on how generic-drug applicants can request a waiver and what the agency will consider when deciding to waive the single, shared system requirement. It also provides recommendations regarding the submission and content of waiver requests. 

FDA is encouraging companies to work together to form a single, shared system. The agency, however, will consider a waiver either upon request of the applicant, or on the agency’s own initiative, at any time. 


According to Gottlieb, FDA “may waive the single, shared system REMS requirement and permit the generic company to use a ‘different, comparable’ aspect of the ETASU [Elements to Assure Safe Use] if the agency finds that (1) the burden of forming a single shared system outweighs the benefits of having one, or (2) an aspect of the REMS is covered by a patent or is a trade secret and the generic applicant certifies that it sought a license for use of that aspect and was unable to obtain one.”

“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. We’re also going to be clearer about the circumstances when we’ll issue waivers to let the generic firms develop their own REMS program. Our safety programs shouldn’t be leveraged as a way to forestall generic entry after lawful IP has lapsed on a brand drug. Our market-based system for rewarding innovation is dependent on this kind of legal competition,” Gottlieb stated.

Source: FDA