FDA Commissioner Outlines Ways to Improve the Generic-Drug Review Process

By Akia Thorpe -

November 10, 2017

US Food and Drug Administration Commissioner Scott Gottlieb has outlined the agency’s approach to increasing generic-drug competition by prioritizing generic drug reviews and addressing potential misuse of the Risk Evaluation and Mitigation Strategy (REMS) system.

As part of the FDA’s Drug Competition Action Plan, the agency has created a new category of generic-drug applications eligible for priority review. “We’re expediting our review of products that lack competition, enabling less expensive generic versions to reach consumers,” Gottlieb said in a statement on November 9th, 2017. “…[W]e’re expanding this competition-focused policy to prioritize any application that can meet the FDA’s approval standards at the point when the 180-day exclusivity period expires on a first generic entrant to a branded medicine. In this way, soon after the 180-day exclusivity period lapses, consumers can have the benefit of brisk competition from multiple other generic entrants. This can improve affordability and access to important drugs.”

This move adds to the agency’s announcement in June 2017 that the FDA will expedite the review of generic-drug applications until there are three approved generics for a given drug product. To accomplish this, the FDA has posted a list of branded drugs that have no listed patents or exclusivities and for which the agency has yet to approve a generic drug application. These changes to the policy are effective immediately.

As another part of the FDA’s Drug Competition Action Plan, the agency said it intends to make sure that Risk Evaluation and Mitigation Strategy (REMS) programs do not become a tool that companies can use to delay or block generic products from entering the market. For drugs that are associated with serious risks, the FDA can require drug makers to develop a REMS to help ensure that the benefits of the drug outweigh the risks.

The FDA said it is exploring a two-pronged approach to address potential misuse of the REMS system. “First, we will continue to work to find ways to encourage the use of shared-system REMS between all innovator and generic companies producing a drug,” Gottlieb said in a statement on November 8th, 2017. “Second, we will explore new steps that the FDA can take to reduce the likelihood that branded drug companies can use the existence of REMS as a way to slow the entry of generic competition.”

Current law requires that branded and generic-drug companies try to reach agreement on the implementation of a single, shared-system REMS rather than maintaining separate REMS for the branded drug and its generic competitor, according to information from the FDA. Any generic drug application referencing a branded drug with a REMS with elements to assure safe use (ETASU) must use a single, shared-system REMS with the innovator unless the FDA waives that requirement and permits the generic drug to use a separate, comparable REMS program. The agency says that negotiations to reach agreement on shared-system REMS can take extended periods of time and that this can block the timely entry of a generic competitor.

To streamline the submission and review process for shared-system REMS (for any REMS that includes more than one medication), the FDA released draft guidance, Use of a Drug Master File for Shared-System REMS Submissions, which describes how applicants can submit collective sets of files to the FDA that represent all participating firms. This draft guidance explains the FDA’s current thinking that the use of a single drug master file (DMF) for shared-system REMS submissions will allow manufacturers with products in shared-system REMS programs to submit one collective set of files to the agency. Submitting shared-system REMS files this way is not yet a requirement and necessitates discussion and negotiation between two potential competitors, noted the FDA Nov. 8 statement.

The FDA said in its Nov. 8 statement that it plans to provide more information about how and when the agency intends to consider waiving the requirement that an innovator and generic use a shared system REMS. These new policy steps will include information on how and when generic-drug applicants can request a waiver and the factors that the FDA intends to consider. A waiver would free generic entrants from the requirement that they reach agreement with a branded firm for a shared system REMS, noted the FDA

Source: FDA (Nov. 8 statement), FDA (draft guidance), and FDA (Nov. 9 statement)