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REMS Vendor Disruptions Prompt Greater US FDA Scrutiny

 
• By Brenda Sandburg

McKesson’s exit from the space forced sponsors to switch vendors managing their REMS programs, which in some instances affected patient access to drugs. Omnibus legislation requires GAO report and collection of public input on factors FDA should consider in reviewing vendor changes.

Vendor
Switching third-party vendors that manage REMS programs can disrupt patient access to a drug • Source: Shutterstock

The third-party vendors who manage Risk Evaluation and Mitigation Strategy (REMS) programs for drug sponsors mostly operate behind the scenes without public attention. But a provision inserted into the omnibus government funding bill indicates that problems in the space after some sponsors switched vendors may pave the way for more open FDA oversight.

The provision requires opening a public docket to seek comments on factors that the FDA should consider when reviewing requests from sponsors to change third-party vendors. Such factors include “the...

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