iPLEDGE changes
Ask the Expert
By Apoorva Stull, Senior Manager, Advocacy Communications, April 1, 2024
DermWorld interviews John Barbieri, MD, MBA, FAAD, co-chair of the Academy’s Acne Guidelines Workgroup, about important changes to the iPLEDGE program.
DermWorld: In a win for the AADA, dermatologists, and their patients, the FDA finally said it would implement important changes to the iPLEDGE program that will alleviate administrative burdens for dermatologists. Tell us about why this is so critical for Academy members?
The changes recommended by the FDA to reduce the need to document patient counseling for those who cannot become pregnant only at enrollment can potentially increase flexibility and improve access to safe use of isotretinoin. In addition, the explicit permission to use home pregnancy testing for follow-up will improve access and reduce logistical barriers to dermatology care. Although there are concerns about the falsification of home pregnancy testing, requesting that the patient provide their name and date with the test can be used to prevent this potential issue. Finally, the elimination of the 19-day lockout period for those who miss an initial window period will enable patients, who often missed a window for no fault of their own, to immediately repeat a pregnancy test to start a new window period so they can access the medication. Together, these commonsense reforms should improve access to safe use of isotretinoin and reduce burdens on patients and clinical practices.
DermWorld: In 2023, 300 AADA members sent about 600 messages to the FDA urging changes to iPLEDGE REMS Program. These grassroots efforts, combined with AADA’s strong advocacy led by its iPLEDGE Workgroup, including testifying during an FDA hearing in March, convinced the FDA to require modifications to the iPLEDGE REMS to minimize burdens on patients and dermatologists while maintaining the safe use of isotretinoin. Tell us about the role collaboration and grassroots advocacy played in your advocacy efforts.
Dr. Barbieri: These grassroots efforts were critical to our advocacy, and I cannot thank our patients and membership enough for their support. We were advocating for these changes for years. The support from patients, AAD members, congressional representatives, and the AADA was instrumental in getting the FDA to hold an Advisory Panel meeting in March 2023, the results of which led to the recently proposed reforms to the iPLEDGE program. In addition, we appreciate the Drug Safety and Risk Management Advisory Committee (DSaRM) and Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) for carefully considering our recommendations to improve the iPLEDGE program during the Advisory Panel meeting.
DermWorld: The iPLEDGE sponsors will be required to implement these changes six months from the date of the FDA’s letter. Then, the FDA has six months to review and approve the changes. Therefore, these changes may take up to a year or more to be implemented fully. What is AADA’s plan to ensure that the FDA and the iPLEDGE sponsors implement and carry out these critical changes?
Dr. Barbieri: The AADA and iPLEDGE Workgroup advocates strongly to ensure that implementation of these changes is patient-centered and will enhance the safe use of isotretinoin. This process is far from over, and we must encourage the FDA and Isotretinoin Products Manufacturing Group (IPMG) to make meaningful reforms to the iPLEDGE program. For example, the FDA has mandated removing that prescribers document monthly patient counseling requirements for those who cannot become pregnant and only require this at iPLEDGE enrollment. We need to make sure that this is also reflected in a decrease in the frequency of counseling and allowing prescription refills without monthly visits. Without these modifications, little will change from a practical perspective.
DermWorld: While FDA’s recommendations are significant, there is more work to be done to improve the iPLEDGE REMS program. Can you walk through those additional improvements and what the AADA is doing?
Dr. Barbieri: While we appreciate the FDA listening to key stakeholders and recommending meaningful reforms to the iPLEDGE program, there is still much to do. As was emphasized at the FDA Advisory Panel meeting in March 2023, there needs to be more transparency and inclusiveness of key stakeholders in the iPLEDGE program. We repeatedly asked both the FDA and the IPMG, which oversees the iPLEDGE program, to allow stakeholders to be involved in improving iPLEDGE. Dermatologists, pharmacists, and patients should be included in developing the iPLEDGE program updates and implementation to ensure that it meets all key stakeholders’ needs and avoids preventable issues such as the failed iPLEDGE 2021 website update.
Additionally, contraception requirements for the program should be updated to be more inclusive of diverse patient populations, to better recognize the effectiveness of long-acting reversible contraception (LARC), and to provide more information regarding how to obtain and use emergency contraception. While the allowance of home pregnancy testing for follow-up visits offers improved flexibility for patients and clinicians, this policy should be expanded to include home pregnancy testing during the 30-day waiting period as well. In addition, there remain important opportunities to improve the accessibility of iPLEDGE to all patients being treated with isotretinoin and to increase the functionality of the iPLEDGE website.
John Barbieri, MD, MBA, FAAD, is an assistant professor at Harvard Medical School and the director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital. He is an associate editor at JAMA Dermatology and is also the co-chair of the Academy Acne Guidelines Workgroup.
Advocacy priorities
Learn about the Academy’s advocacy priorities and how to join efforts to protect your practice.
