Dear Colleagues:
Today, we met with the FDA, the Isotretinoin Product Manufacturers Group (IPMG), pharmacists, and other relevant stakeholders to continue our discussions on the significant issues with the iPLEDGE program.
During this joint stakeholder meeting, the IPMG shared that some issues with the iPLEDGE program have been addressed, but there is still ongoing improvement. Additionally, the FDA was amenable to reevaluating the current program and expressed interest in long-term fixes to the iPLEDGE system. The AADA is encouraged by this and has requested regularly scheduled joint meetings to hold the IPMG and the FDA accountable for ensuring that the iPLEDGE program effectively meets its stated goals of preventing fetal exposure without causing unintended harm to patients.
Though the IPMG has reported recent steps to make improvements in the system, we all agree that is not enough. Our asks for a long-term fix still stand, which include:
- Remove from iPLEDGE REMS the monthly physician attestation requirements for patients who cannot become pregnant.
- Remove the 19-day “lockout” period if a patient misses an initial window period.
- Increase transparency and improve inclusion of stakeholders, including dermatologists to address the current crisis and to prevent future issues with the program.
Share your feedback: If you are continuing to experience issues with the iPLEDGE platform, please fill out this form to help inform ongoing advocacy for short- and long-term solutions.
Our advocacy continues, and we will keep you informed with new updates. Please find below a holistic view of the Academy’s efforts to resolve these immediate concerns which include:
- Regular meetings with the FDA, IPMG, pharmacists, and other relevant stakeholders.
- Direct outreach to the isotretinoin manufacturers.
- Calling on key congressional offices to 1) reach out to the FDA on our behalf and 2) develop strategies to continue the pressure.
- Responding to media requests seeking dermatologists' perspective and the plight of the patients being impacted.
- Coalition building which includes bolstering our partnerships with the National Association of Chain Drug Stores and the American Psychiatric Association, whose members have experienced a remarkably similar breakdown in the REMS program for clozapine.
We remain steadfast in our asks to stabilize the iPLEDGE program, requesting physician input for future improvements, maintaining safe access to isotretinoin, and identifying agreeable solutions with all stakeholders involved.
Lastly, please refer to the iPLEDGE guidance in the Academy’s Practice Management Center for the latest information.
Sincerely,
Bruce Brod, MD, MHCI, FAAD
Chair, AADA Council on Government Affairs and Health Policy
