URGENT: iPLEDGE Program and AADA Actions

Dear ADAM Members:

We have all felt the pain of the iPledge system changes this week, and continue to feel them today. The AADA is working tirelessly to fix these issues with the FDA, Syneos Health and HHS. Please see the most recent update from the AADA and their updated call for action. We will continue to pass along information as we receive it. The below message was sent from the AADA to ADAM.

Please have your AADA member physicians utilize their grassroots alert to complain directly to the FDA. Together with the AADA we can have our voices heard and advocate on behalf of our patients to get the medication they need.

Janice Smith
President of ADAM.

UPDATE

Please note we just sent a member alert regarding a meeting we have secured with the FDA which is below. Please utilize the link to submit your personal experience so the FDA is aware.

AADA to meet with leaders of HHS, FDA, and Syneos Health

Due to the Academy’s tireless outreach regarding the unacceptable situation with iPLEDGE, the FDA has convened an emergency meeting with AADA representatives and Admiral Rachel L. Levine, MD, assistant secretary for health; Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research; and the CEO of Syneos Health, the iPLEDGE administrator, on Thursday, Dec. 17.

The Academy also received an update yesterday from representatives with Syneos Health, who acknowledged the AADA’s concerns and reported they are actively working with their service providers to resolve website issues, hold times, and access to the call center, although a timeline was not provided.

At the Thursday meeting, AADA representatives will underscore the urgent situation faced by dermatology patients unable to secure their prescriptions, repeat calls for a halt to the program so that care can be restored without further delay and disruption, and outline plans for how dermatologists will maintain patient safety while the program is suspended.

AADA is encouraging members to continue to share experiences leading up to the Thursday meeting with the FDA via our grassroots Take Action Center.

AAD member communication regarding the meeting.

Dear Members of ADAM,

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.

A FAQ for members, talking points for members in discussing the topic externally, and a more expanded communications plan of what’s been done to date on the members side has been added below. We have emailed FDA and Syneos, and a formal letter from Dr. Tomecki is on its way shortly. We also have 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.

Any help you can provide to respond to members about all the AADA has been doing for them not just in the past few weeks, but for years around this program would be helpful. 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):

Audience	Tactic
Regulatory Outreach FDA CDER Syneos Asst. Secy Levine	Email to FDA from staff Email to Syneos from staff Letter to FDA CDER from Dr. Tomecki (cc Secy Levine and email separately)
Congressional Outreach	Follow-up email to staff of House Energy & Commerce Chair Frank Pallone and Senate HELP Chair Patty Murray including FDA response, and outlining issues and asking the Chairs/staff to weigh in with FDA
Media Outreach	Outreach to various healthcare and health policy news media trades including Politico, Modern Healthcare, Axios and Medpage. Media Statement approved and will be distributed Op Ed in development
Member Outreach & Engagement	Email response for Practice Center Member Resource Center: Provide FAQs document on iPLEDGE (attached) Grassroots: Draft email that our members can send to FDA and personalize to send on their own (will need to ensure we have the appropriate person/email contact at FDA) iPLEDGE Workgroup: Share FAQs document and iPLEDGE draft email so AAD members can contact FDA Email to Leadership with FAQ and talking points President’s Message Practice Management Center: Workflow document and other resources are live on AAD.org
Internal/Administrative	Create Excel to capture member concerns Create Shared Dropbox for iPLEDGE materials