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# FDA Wants to Reduce Companies Gaming REMS
- URL: https://www.fdaweb.com/fda-wants-to-reduce-companies-gaming-rems/
- Published: 2017-11-08T12:00:00.000Z
- Updated: 2026-09-14T23:00:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140082

FDA commissioner **Scott Gottlieb** says the agency is looking at steps it can take to reduce the likelihood that branded drug companies can use the existence of a Risk Evaluation and Mitigation Strategy (REMS) as a way to slow the entry of generic competition. In a [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584259.htm?ref=fdaweb.com), Gottlieb said the effort is part of a broader strategy, including finding ways to encourage the use of shared system REMS between all innovator and generic companies producing a drug.

Negotiations between branded and generic companies on a shared system REMS can take extended periods of time, Gottlieb says, and can block the timely entry of a generic competitor. “I believe branded firms sometimes use these negotiations strategically, as a way to slow generic competitors,” he adds.

To further streamline the submission and review process for shared system REMS, FDA is issuing a draft [guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM584202.pdf?ref=fdaweb.com), *Use of a Drug Master File for Shared System REMS Submissions*, describing how applicants can submit collective sets of files to FDA representing all participating firms. “Currently,” Gottlieb says,” under a shared system REMS, multiple applicants need to coordinate the submission of identical REMS-related documents for their respective applications. This draft guidance explains FDA’s current thinking that the use of a single Drug Master File for shared system REMS submissions will allow manufacturers with products in shared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. This is a first step toward additional actions FDA plans to take to make sharing a single REMS easier.”

Going forward, Gottlieb writes, FDA will look more specifically at how it can address situations where innovator firms may be leveraging the single, shared system REMS requirement to block or delay generic competition.

“We plan to provide more information about how and when FDA intends to consider waiving the requirement that an innovator and generic utilize a shared system REMS,” he says. “These new policy steps will include information on how and when generic drug applicants can request a waiver and the factors that 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. This can obviate the ability of branded sponsors to use these negotiations as a way to slow generic entry.”