US FDA Announces Two Proposals to Curb Generic-Blocking Tactic

June 1, 2018: By Jon Swedien

The US FDA on May 31 proposed two policies aimed at stopping makers of branded drugs from manipulating the agency’s safety rules to halt generic drug development.

FDA Commissioner Scott Gottlieb said branded drug companies sometimes impede generic drug developers from complying with rules that require both sides to share a Risk Evaluation and Mitigation Strategy (REMS) program. This sharing requires the generic drugmaker to negotiate with the branded drugmaker.

“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,” Gottlieb said.

One of the two guidance documents the FDA released May 31 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.

The other draft guidance describes new, clarified rules that specify how generic companies can request a waiver from the rule requiring a shared REMS program, Gottlieb said.

The guidance document states the shared system REMS requirement will be waived if the burden of forming a single shared system outweighs the benefits of having one or if 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.

“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,” Gottlieb said.

Gottlieb also said branded drugmakers have blocked would-be generic competitors from accessing their products for testing.

He said generic drugmakers typically need up to 5 thousand doses of a branded drug to run bioequivalence and bioavailability studies to prove the generic medicine is the same as the branded drug.

To address the issue, the FDA published on May 17 a list of companies that might have blocked access to samples. The agency also laid out steps to address the issue.

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