iPLEDGE issues are an unacceptable disruption to patient care

The Academy is aware of the issues faced by dermatologists and patients attempting to use the new iPLEDGE platform beginning yesterday; and leadership agrees that this is not acceptable for our patients or our practices. We have contacted the FDA and Syneos to urgently communicate that the new platform rollout has been a nightmare for dermatology practices and patients; and it has created an unacceptable disruption in patient care. In addition, we are reaching out to congressional committees overseeing the FDA asking them to take action and have contacted health policy reporters to shine a light on the crisis.

Over the last several weeks we have repeatedly warned the FDA and Syneos that the proposed changes did not reflect clinical practice and would impede patient care; and we asked for a halt to the program until our concerns could be addressed. We were told “no,” with the explanation that suspending the iPLEDGE program would not, from FDA’s perspective, provide the safeguards that are necessary to prevent embryofetal exposure. They also assured us that the iPLEDGE administrator was taking steps to address many of our concerns before launch. Clearly, those steps have not been effective.

The Academy appreciates all members’ messages via our Member Resource Center. We will use those messages and shared experiences as we renew our calls for an immediate suspension to the program and continue efforts to urgently seek solutions to the current crisis as well as to longstanding issues with the program.

It’s also critical that the FDA hear the collective voice of dermatologists about the impact on your patients. Please look for an email link later today and share your experience via the Academy’s grassroots Take Action Center.

Kenneth J. Tomecki, MD, FAAD
President, American Academy of Dermatology Association