iPLEDGE changes
Ask the Expert
By Victoria Houghton, Managing Editor, July 1, 2023
DermWorld spoke to Stephanie Croney, JD, assistant director of regulatory policy for the American Academy of Dermatology Association (AADA), about the recent FDA advisory committee meeting on recommended changes to the iPLEDGE REMS program.
DermWorld: Recently, FDA advisory committees recommended vital changes to the iPLEDGE REMS Program. Just as some background, what are FDA advisory committees and what role do they play in FDA policies?
Stephanie: Advisory committees offer independent expert advice and recommendations to the FDA on certain products and scientific topics. FDA’s advisory committees assist the agency in making decisions about these topics and/or products based on carefully vetted scientific studies, manufacturer data and public information. Although it is not legally required to follow advisory committee members’ recommendations, the FDA typically accepts the committee’s proposed changes.
The Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee met on March 28–29, 2023, to address upcoming changes to the iPLEDGE REMS to minimize physician and patient burdens while maintaining safe use of isotretinoin oral capsules.
DermWorld: Why did the FDA hold this joint committee meeting on iPLEDGE changes?
Stephanie: The AADA’s entire iPLEDGE Workgroup relentlessly advocated over several years to fix iPLEDGE, and its efforts only intensified following the disastrous rollout of the new iPLEDGE REMS platform in late 2021. Prior to the meeting, the FDA approved several minor changes the Academy has advocated for since the transition to the new platform.
As a direct result of the AADA’s persistent advocacy efforts to fix the iPLEDGE program, in early 2023, the FDA announced it would host a two-day joint committee meeting. This hearing was one of the many ways that the AADA is addressing member concerns and frustrations with the iPLEDGE REMS Program.
iPLEDGE advocacy
Read about the AADA’s advocacy efforts on iPLEDGE.
DermWorld: How was the Academy involved in this hearing?
Stephanie: The AADA participated in the meeting and once again provided its recommendations to improve the iPLEDGE program to the FDA. AADA iPLEDGE Workgroup leaders, Ilona Frieden, MD, FAAD, and John Barbieri, MD, FAAD, presented oral testimony outlining Academy members’ concerns about and recommendations for the program, and the AADA submitted written comments. Additionally, 286 member dermatologists submitted comments to the FDA through the AADA’s member action alert center.
DermWorld: Was the AADA working with other societies on this hearing?
Stephanie: The AADA worked with other societies to submit testimony and/or draft comments. AADA iPLEDGE Work Group member, Andrea Zaenglein MD, FAAD, presented oral testimony on behalf of the American Acne & Rosacea Society. The AADA also provided talking points to the Society of Pediatric Dermatology and the Foundation for Ichthyosis & Related Skin Types to help with their testimony.
DermWorld: What happened during the meeting?
Stephanie: At the meeting, joint advisory committee members voted and discussed key changes to the program. Overall, their recommendations are aligned with the AADA’s recommendations for the program:
Over 75% of the committee voted to remove the 19-day lockout period.
Most advisory committee members discussed allowing patients to have access to home pregnancy testing for iPLEDGE after the public health emergency and nearly all support non-CLIA pregnancy tests for in-office testing.
73% of the committee members voted to reduce the monthly attestation requirement to every four months or at the time of enrollment, for patients who cannot become pregnant.
Many members were in support of Isotretinoin Products Manufacturers Group (IPMG) having physician and stakeholder representation, including regular meetings with the manufacturers.
AADA advocacy priorities
Read more about the AADA’s advocacy priorities.
DermWorld: What happens next?
Stephanie: Although the FDA is not legally required to follow advisory committee members’ recommendations, it typically accepts the committee’s proposed changes with limited modifications. In fact, shortly after the hearing, the FDA officially extended some COVID-19-related flexibilities through fall 2023, including accepting at-home pregnancy tests and other non-CLIA tests for the iPLEDGE REMS. The AADA will continue to follow up with the FDA and urge it to quickly accept and implement these recommendations. The AADA’s iPLEDGE Workgroup will continue to advocate for needed improvements to the iPLEDGE REMS program with the FDA and iPLEDGE sponsors.
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