AADA pressure on FDA results in iPLEDGE wins
As a result of the Academy’s advocacy efforts, the FDA held a joint advisory committee meeting to discuss ways to minimize the burden of the iPLEDGE REMS program on patients and dermatologists while maintaining safe use of isotretinoin oral capsules for patients.
Overall, their recommendations were 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 remove the monthly attestation requirements to 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.
As a follow-up to the FDA’s hearing, we urged the agency to adopt the advisory committee’s recommendations. Additionally, we asked the FDA to encourage the IPMG to engage in transparent and consistent communication with our members.
Shortly after the hearing, the FDA officially extended certain COVID-19-related flexibilities through fall 2023, including accepting at-home pregnancy tests and other non-CLIA tests for the iPLEDGE REMS program. The AADA sent a follow-up letter to the FDA requesting that it accept this recommendation and make other necessary changes to the program.