In May 2018, the United States Food and Drug Administration (FDA) issued two draft guidance documents focused on developing a shared system Risk Evaluation and Mitigation Strategy (REMS), and waivers associated with the single, shared system REMS requirement.
FDA Commissioner Scott Gottlieb has spoken about the way pharmaceutical sponsors can exploit REMS to block generic drugs from making a timely entry to market, “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,” he said. But the guidance seeks to deal with the other obstacle on the back end, or “after a generic drug seeks FDA approval and market entry.” He acknowledged that in such cases, negotiating a single, shared REMS “can extend for long periods of time.”
He noted that the two draft guidance documents were being released in tandem and that the aim is to “help generic drug makers get their products through the development and approval processes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.”
Development of a Shared System REMS
The first draft guidance, Development of a Shared System REMS, describes general principles and recommendations to assist sponsors with developing these programs.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 is expected to enable timelier market entry for products that are part of these REMS.
According to the draft guidance, the Agency will “request that applicants of the pending applications submit an authorization for disclosure that will allow the Agency to hold meetings between multiple applicants. FDA will provide contact information for the product being referenced by the pending applications to facilitate the development of a shared system REMS.”
Further, while FDA noted that it “does not advise on the business arrangements being negotiated or arbitrate substantive disputes about the terms of contracts,” the agency “will set forth expectations of the applicants for the development of the shared system REMS, which may include suggested timeframes for various milestones in the process of developing the shared system, and the process for submission of the proposed REMS. FDA may facilitate collaborations between applicants when necessary to achieve a shared system REMS. For example, FDA may host teleconferences to encourage communications between applicants.”
Waivers of the Single, Shared System REMS Requirement
The second draft guidance, Waivers of the Single, Shared System REMS Requirement, describes when and how the FDA will consider waiving the single, shared system requirement, and how generic applicants can request a waiver. The FDA may waive the single, shared system REMS requirement and permit the generic company to use a “different, comparable” aspect of the Elements to Assure Safe Use (ETASU) 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. This draft guidance also describes the factors the FDA will consider in evaluating a request for a waiver of the single, shared system REMS requirement. The guidance further makes clear that while the FDA encourages companies to work together to form a single, shared system, the agency will consider a waiver at any time (either upon request of the applicant, or on the agency’s own initiative). Lastly, the draft guidance also provides recommendations to generic drug applicants regarding the submission and content of waiver requests.