FDA Delays Isotretinoin REMS Modifications

FDA says there is an implementation delay for isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) modifications. The modifications were scheduled to go into effect 8/8, but the planned implementation date has been changed to 11/15 because more time is needed to test iPLEDGE REMS system updates, minimize technical issues for users of the iPLEDGE REMS platform, and help ensure patients have uninterrupted access to isotretinoin treatment.

FDA previously noted the changes relate primarily to completing required pregnancy tests outside of a medical setting and permitting a repeat pregnancy test immediately, without an additional waiting period, if a person who can get pregnant does not pick up a prescription within seven days.

Until the modifications are fully implemented, FDA says it will continue to exercise enforcement discretion regarding pregnancy testing requirements, as detailed in the agency’s October 2023 update.