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iPLEDGE REMS: US FDA Advisory Cmte. Supports Relaxing Restrictions But Wants More Data

 
• By Brenda Sandburg

Panel favors elimination of 19-day lockout after patients who can become pregnant miss the first prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.

Isotretinoin foil package
US FDA advisory committee recommends changes to iPLEDGE isotretinoin REMS program • Source: Shutterstock

An advisory panel voted on the US Food and Drug Administration’s proposals to reduce the burden that prescribers and patients face in satisfying the requirements of the isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy. But their resounding message was the need for more data from the sponsors on a variety of issues, including why patients are not participating in the pregnancy registry and disparities in access and counseling.

At its joint 28-29 March meeting, the agency’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee voted on two questions posed by the agency

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