US FDA Asks Manufacturers To Fix Disruption In Isotretinoin REMS
The agency offers ‘regulatory flexibility’ for certain requirements of the iPLEDGE REMS for the acne drug if manufacturers address delays in implementing the modified program.
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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.
US FDA is once again considering changes to the Risk Evaluation and Mitigation Strategy for the acne medication, a year after modifications to the program caused disruptions in patient access.
Providers are eager for the FDA to test integrating REMS requirements into electronic health records, but want the agency to ‘go slowly’ to avoid any disruptions along the way. Recent issues with two of the original restricted distribution plans in the US underscore the message of caution.