New FDA Policies to Help Generic, Biosimilar Drug Competition and Access


New policies that aim to help generic drug makers move their products through the development and approval processes more efficiently have been announced by FDA Commissioner Scott Gottlieb, MD.

FDA Commissioner Scott Gottlieb, MD announced new FDA policies that aim to help expedite the development and approval processes for generic drugs, according to a press release. The policies also aim to maintain safety controls sought by the Risk Evaluation and Mitigation Strategy (REMS) requirements.

“The first draft guidance being issued today,

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 in a statement. “The second draft guidance,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.”

According to Gottlieb, 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 law if the agency finds that the burden of forming a single shared system outweighs the benefits of having one, or 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 This draft guidance describes the factors the FDA will consider in evaluating a request for a waiver of the single, shared system REMS requirement, Gottlieb said in his statement. The guidance 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. The draft guidance also provides recommendations to generic drug applicants regarding the submission, and content of waiver requests.

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