iPLEDGE win included in year-end package

The AADA’s 2022 advocacy efforts were successful in securing provisions on the iPLEDGE Program within the omnibus spending package that was signed into law in December 2022.

Language that the AADA championed will require the FDA to provide a public comment period regarding patient access and provider administration when a proposed modification to an approved risk evaluation and mitigation strategy (REMS) is made.

Following the iPLEDGE crisis in 2021 and early 2022, the AADA partnered with the American Psychiatric Association to work with Reps. John Joyce, MD, FAAD (R-PA), Doris Matsui (D-CA), and Morgan Griffith (R-VA) to develop legislative language with the goal of protecting against such a crisis occurring in the future.

The AADA continues to put pressure on the Isotretinoin Product Manufacturers Group (IPMG) and the FDA to advocate for improvements to the iPLEDGE Program.

In 2022, leaders of the AADA’s iPLEDGE Workgroup again met with representatives from the IPMG and the FDA to advocate for improvements to the iPLEDGE Program, including:

• reinstating the calendar functionality

• enhanced enrollment process

• general prescriber and designee updates.

The IPMG again shared that the upgrades could take six months to a year to implement, noting the FDA must approve these changes first, after which the vendor will need time to implement them within the iPLEDGE site. The AADA again pressed IPMG to expedite the implementation of these changes.

Additionally, the AADA took the opportunity to repeat calls for the IPMG to address issues that have plagued the program for years, including:

• Removing the monthly physician attestation requirements from iPLEDGE REMS for patients who cannot become pregnant.

• Removing the 19-day “lockout” period if a patient misses an initial window period.

While IPMG showed more willingness to address the AADA’s concerns to the program for patients who cannot get pregnant, the AADA will continue to pressure IPMG on both issues, so all patients have better access to needed treatments.