FDA has approved an update to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program. The centralized system helps inform pharmacies, prescribers, and patients about any serious risks associated with isotretinoin to prevent fetal exposure. Since the system changes were implemented in mid-December 2021, some users have experienced problems with the updated website, including patients having difficulty gaining access to the website and call center. FDA has acknowledged these issues and is urging the Isotretinoin Products Manufacturers Group to propose a workable solution.
FDA indicates that the agency is ready to exercise “regulatory flexibility on a temporary basis as needed” for some iPLEDGE REMS requirements so long as “IPMG proposes a workable solution that also ensures necessary safe use conditions are maintained.” FDA will continue to post any timely updates related to iPLEDGE REMS in its effort to provide isotretinoin information to prescribers, pharmacies, patients, and distributors.
More information is available via a press release and statement published on the FDA website.