Advocating for you — iPLEDGE advocacy forges ahead, with opportunities for positive change
Since the rollout, the AADA and physician members of its iPLEDGE Workgroup have met with the IPMG and FDA several times, outlining our concerns, and proposing several long-term reform solutions to iPLEDGE and other REMS programs.
When the iPLEDGE program announced its intent to switch platforms in October 2021, the AADA iPLEDGE Workgroup immediately flagged significant potential problems for the program’s sponsors. Unfortunately, those concerns were well founded, and the extremely problematic rollout in December 2021 resulted in unnecessarily delayed treatment for patients. While the FDA and the Isotretinoin Product Manufacturers Group (IPMG) failed to act with appropriate speed in response to urgent calls from the AADA, pharmacy groups, and patients, the iPLEDGE crisis — along with a similar failure in the clozapine Risk Evaluation and Mitigation Strategy (REMS) program rollout — has renewed opportunity for the Academy to advocate for improvements to the program, a longstanding AADA goal.
Since the rollout, the AADA and physician members of its iPLEDGE Workgroup have met with the IPMG and FDA several times, outlining our concerns, and proposing several long-term reform solutions to iPLEDGE and other REMS programs, including:
Remove 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.
Additionally, the Academy and the American Psychiatric Association enlisted support from AADA champions on the House Energy and Commerce Committee to ask and submit for-the-record questions for the FDA on the flawed REMS process at a congressional hearing that focused on the reauthorization of user fees for drugs and medical devices.
Through regularly scheduled joint meetings with the IPMG and FDA, and with continued pressure from our allies in Congress, we will hold them accountable for ensuring that the iPLEDGE program effectively meets its stated goals of preventing fetal exposure without causing unintended harm to patients.
The collective voice of dermatologists answering our calls to action brought the FDA to the table and opened a door for a conversation about a long-term fix. We will continue to push to stabilize the iPLEDGE program — requesting physician input for future improvements, maintaining safe access to isotretinoin, and identifying agreeable solutions with all stakeholders involved. Our advocacy ends when the program is fixed.