REMS Vendor Disruptions Prompt Greater US FDA Scrutiny
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.
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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.
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.
US FDA says pharmacists may dispense the antipsychotic without a REMS authorization and wholesalers may continue to ship it during temporary suspension of REMS. A high call volume and long wait times have impacted patient access since the modified REMS launched on 15 November.