*Please see the message from Barbara Greenan, Sr. Vice President, Advocacy & Policy, regarding the iPLEDGE platform*
As I’m sure you are aware, the new FDA-approved, Syneos-administered iPLEDGE platform went live Monday with drastic results. As we are being bombarded with hundreds of emails from very frustrated members, our internal staff team wanted to bring you up to date on the actions we are taking in partnership with the AADA iPLEDGE Workgroup led by Ilona Frieden, MD, FAAD and John Barbieri, MD, FAAD; and with input from our Council on GAHP Chair, Bruce Brod, MD, MHCI, FAAD.
First and foremost, we are continuing to seek an emergency halt to this program.
I’ve also attached:
• an FAQ for members
• talking points for members in discussing the topic externally, and
• an expanded communication plan of what’s been done to date on the members side.
In addition, we have:
• emailed FDA and Syneos, and a formal letter from Dr. Tomecki is on its way shortly.
• an all-member alert queued up and ready to roll as soon as we get the link to our grassroots alert posted, so please keep an eye on your email from the Academy.
We know that members have been writing directly to their members of Congress as well as to FDA in addition to our practice center and member resource center.
Background:
Over the last several weeks since the iPLEDGE programmatic changes were announced, we have repeatedly warned the FDA and Syneos that the proposed changes did not reflect clinical practice and would impede patient care. The Academy met with more than 50 members of the FDA the first week of December and after presenting our significant concerns with both the old and the new systems, asked for a halt to the program until those 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 yesterday’s launch. Clearly those steps were not effective. Our outreach since yesterday (Dec. 13) has included submitting an emergency request for FDA to reconsider.
Other steps are as follows: please let us know if you have any questions.
Actions To Date (either completed or in progress):
