US FDA Asks Manufacturers To Fix Disruption In Isotretinoin REMS

The US Food and Drug Administration is willing to loosen requirements for the Risk Evaluation and Mitigation Strategy (REMS) for the acne medication isotretinoin if manufacturers can come up with a solution to problems implementing a recent modification of the program.

The agency noted that since the revisions to the iPLEDGE REMS went into effect on 13 December, many patients, prescribers and pharmacies have been unable to log into the REMS website or have had long call center wait times,