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AADA keeps pressure on IPMG to fix iPLEDGE REMS program

Illustration for Impact Report on iPLEDGE

Recently, leaders of the AADA’s iPLEDGE Workgroup again met with representatives from the Isotretinoin Product Manufacturers Group (IPMG) and the FDA to advocate for improvements to the iPLEDGE Program.

The purpose of the meeting was to follow up on the status of the planned updates that were shared during the previous meeting held on May 18, including reinstating the calendar functionality, enhanced enrollment process, and 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.

Finally, the AADA again requested a multi-stakeholder meeting with IPMG, patients, and physicians, among others, to work together on a long-term fix to the program. Unfortunately, the IPMG declined this request, but the AADA plans to make this request directly with the FDA.