Dear Colleagues:

Throughout the holidays, the American Academy of Dermatology Association (AADA) has continued to pressure the iPLEDGE Product Manufacturers Group (IPMG) to halt the program, fix its platform, or find reasonable workarounds to restore patient access to isotretinoin. On December 30, members of the AADA iPLEDGE Workgroup were invited to meet with members of the IPMG, who were seeking feedback from the AADA on a possible workaround that would allow physicians who are unable to access the system to fax a form with a universal Risk Management Authorization (RMA) in lieu of going through the iPLEDGE platform. Those who have managed to successfully access the system would continue to do so.

This solution was reflective of some of the feedback the AADA has shared with the FDA and IPMG; however, as we noted during the meeting and in subsequent communication to the FDA and IPMG, this will not work for all scenarios, and it is critical to consider multiple pathways toward a solution. In addition to our feedback on IPMG’s proposal, we put forward the following suggested solutions:

• Instead of requiring that patients who cannot get pregnant be qualified monthly to receive isotretinoin, require qualification only at the time of enrollment and once yearly thereafter.
• The removal of patient attestation requirements, which would allow patients who are unable to access the system to receive isotretinoin, once qualified by their prescriber.
• Amnesty for those who missed window periods and were inappropriately put back into the 30-day waiting period.

We are also calling for increased transparency from the IPMG regarding the status of iPLEDGE, including call wait times, which we understand anecdotally remain high, and how many prescriptions are currently being filled as compared to prior to December 13. We also called for more direct discussion among stakeholders to expedite delivery of a solution for patients, physicians, and pharmacists and as we press for long term reform of the iPLEDGE risk evaluation and management strategy.

Additionally, we are working with media outlets to share information on this issue, including Medscape, Dermatology Times, Fox5 DC, Bloomberg Law, and TODAY.

As our advocacy on this issue continues, we would like to share more information with IPMG and FDA about how this situation is impacting patients. Please share this link with your patients and ask them if they would be willing to share their story with us at www.aad.org/iPLEDGEstories. No individually identifiable information will be collected or shared with stakeholders.

Sincerely,

Bruce Brod, MD, MHCI, FAAD
Chair, AADA Council on Government Affairs and Health Policy