FDA to improve the review of shared Risk Evaluation and Mitigation Strategies to enhance generic drug access

December 1, 2017

The U.S. Food and Drug Administration (FDA) manages the risks that are associated with the use of drugs, ensuring that the benefits exceed the risks by developing a Risk Evaluation and Mitigation Strategy (REMS).

Currently, each manufacturer of a new type of drug is required to submit separate documents to the FDA for review. Therefore, many of these drug companies use the REMS process as an approach to reduce competition by blocking generic products from entering the market.

In order to prevent this, the FDA propose to promote the use of shared REMS between innovators and generic drug-producing companies by releasing a draft guidance document describing how applicants can submit collective files that represent all companies involved. This new process eradicates the need for separate files from each of the manufacturers, streamlining the process, creating less paperwork for the FDA to review and subsequently eliminating the requirement that all parties reach an agreement for a shared REMS. This, in turn, removes the possibility for drug companies to use REMS as a way to inhibit generic products from entering the market.

To read more about this, please visit the FDA website.


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