FDA Issues Draft Guidances to Facilitate Generic-Drug Development and Approval

The US Food and Drug Administration (FDA) has issued two draft guidances to improve the Risk Evaluation and Mitigation Strategy (REMS) process to facilitate generic-drug development and approval. REMS is a program that the FDA implements for certain drugs to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use. The measures by the FDA seek to eliminate what it sees as potential misuse of the REMS system to delay entry of generic drugs.  

“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,” said FDA Commissioner Scott Gottlieb said in a May 31, 2018 agency statement. “The other obstacle occurs at the back end, after a generic drug seeks FDA approval and market entry. This is the impediment we’re seeking to address today, with the new policies that we’re announcing.”

To address those issues, the FDA has issued draft guidances, Development of a Shared System REMS and Waivers of the Single, Shared System REMS Requirement. Under current practice, brand and generic- drug makers are required to develop a single shared REMS program when a generic drug seeks approval and the brand drug has a REMS associated with it. This requirement applies when a generic-drug applicant wants to market a generic version of a drug that has REMS with certain requirements or activities known as “Elements to Assure Safe Use” (ETASU). The current law requires that the brand and generic companies use a single, shared system REMS, unless the FDA waives that requirement and permits the generic drug to use a separate, comparable REMS program.

“..The generic drug maker has to negotiate with the brand firm to enter into a shared REMS programs before the generic drug can be approved,” explained Gottlieb in his statement. “We know that these negotiations between a brand and generic company—to reach agreement on shared system REMS—can extend for long periods of time. This can delay market entry of a generic drug. While the FDA recognizes that these negotiations are an important step in the formation of a shared system REMS, the agency is also committed to making sure that REMS programs maintain their role in serving public health. The REMS shouldn’t become a tool that drug companies can use to delay or block competition from generic products or hinder their ability to enter the market.”

The first draft guidance, Development of a Shared System REMS, describes general principles and recommendations to assist sponsors with developing these programs. The FDA says its 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.

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. In the draft guidance, the FDA outlines that it may waive the single, shared system REMS requirement and permit the generic company to use a “different, comparable” aspect of the 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. The draft guidance describes the factors the FDA will consider in evaluating a request for a waiver of the single, shared system REMS requirement.

Source: FDA (Statement from FDA Commissioner), FDA (waivers guidance), and FDA (REMS recommendations)





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