FDA Panel Questions Isotretinoin iPLEDGE REMS

Panelists at joint meetings of 2 US Food and Drug Administration (FDA) advisory committees have voted to modify two aspects of the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin; a drug for severe, nodular acne that is highly teratogenic. ¹

The first vote involved the 19-day lockout period for patients who are able to become pregnant and do not pick up their prescription for isotretinoin in the allotted 7-day window. Currently, those patients have to wait 19 days to get their second pregnancy test and receive the prescription.

17 out of 22 voting members voted not to continue the 19-day period but there was no consensus on when the second pregnancy test should take place if the 19-day lockout changed.

The second question concerned patients who cannot become pregnant, and it asked when REMS should require that the prescriber document counseling the patient in the iPLEDGE system. The advisory committees also discussed recommendations to encourage more participation in the iPLEDGE Pregnancy Registry.

The usefulness of the iPLEDGE program's pregnancy registry came into question during the hearings. Currently, the registry collects data on fetal exposure, pregnancy outcome, fetal outcome, and root cause analysis. FDA staff sought out views of the committee members on whether the program should continue to collect that personal information.

All formulations of isotretinoin are currently available under the iPLEDGE REMS, a restricted distribution program designed to reduce the risk of embryo-fetal toxicity associated with isotretinoin use. The program was created to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about the drug’s risks. The most recently approved REMS (approved October 6, 2021) for iPLEDGE consists of elements to assure safe use (ETASU), an implementation system, and a timetable for the submission of assessments of the REMS.

Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater.

Last winter, Dermatology Times reported on a previous FDA update regarding the iPLEDGE program, and the number of people locked out of the program. Gain more background insight on the initiative here.

Reference

1. Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement FDA. Published online March 28, 2023. Accessed March 31, 2023. https://www.fda.gov/advisory-committees/advisory-committee-calendar/march-28-29-2023-joint-meeting-drug-safety-and-risk-management-advisory-committee-and-dermatologic