Commissioner outlines new policies for drugs that have Risk Evaluation and Mitigation Strategy (REMS) requirements.

In a recent statement, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb introduced new agency policies to address challenges faced by generic drug manufacturers looking to introduce new generics for branded drugs that have Risk Evaluation and Mitigation Strategy (REMS) requirements.

Gottlieb discussed two different tactics used by branded drug makers to delay the introduction of these types of generics. Drugs with REMS requirements have serious risks associated with them, and as such FDA requires drug makers to develop REMS to ensure that the benefits outweigh those risks.

The first tactic involves limiting the sale of REMS drugs so that generic makers cannot get access to the material needed (up to 5000 doses) to conduct the bioequivalence and bioavailability studies necessary to demonstrate equivalency for their products. This approach slows down the ability of the generic firm to apply for approval

The second tactic is used after the generic company has submitted an application to FDA. For drugs with REMS requirements, the generic and branded drug makers must market their products under a single shared REMS program, even when the drug in question has a REMS with requirements or activities known as “Elements to Assure Safe Use” (ETASU). The shared program must be established before the generic drug can be approved. To use a separate REMS program, the generic company has to get FDA to waive the requirement for a shared program, which is difficult to do.

Branded drug makers are known to extend the negotiation period for the development of shared REMS programs in order to delay market entry of generic products. FDA recognizes that the negotiations are important to developing shared REMS programs, but does not believe that the need for shared REMS programs should be used by branded drug makers to block competition from generic products.

Two draft guidances have been issues. The first, entitled Development of a Shared System REMS, outlines general principles and recommendations to assist sponsors with developing these programs and is intended to improve the clarity and efficiency of the process, leading to reduced time to market for generics. The second, entitled Waivers of the Single, Shared System REMS Requirement, outlines how generics firms can request waivers to the shared REMS program requirement and how and when FDA will grant them. Waivers will be granted if “(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.”

Gottlieb went on to say that: “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.”

 

 

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