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

 

The Current REMS Process

Currently, manufacturers must submit documents for a new type of drug to the FDA. This is so the FDA can review them. Therefore, many of these drug companies use the process as an approach to reduce competition. They do this 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FDA propose to promote the use of shared REMS between innovators and generic drug-producing companies by releasing a draft guidance document describing how applicants can submit collective files that represent all companies involved.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 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.