Isotretinoin iPLEDGE REMS Proposed Revisions To Get Two-Day AdComm Review
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.
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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.
After FDA clears modified REMS, certified retail pharmacists are permitted to dispense the abortion medication. Some advocates argue program is unnecessary, while others want a broader federal effort to expand access. Walgreens intends to become a certified pharmacy.
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.