Michelle Marie

iPLEDGE day 8 update: -Website still dysfunctional -Call center still dysfunctional -Platform administrators not acting responsibly (who are they?) -We continue to actively propose workarounds to FDA & pharmacists 🚨We need brave action from @US_FDA to immediately halt iPLEDGE🚨

iPLEDGE call center is still terribly dysfunctional. Have not gotten through a single time in over a week, despite 30+ attempts. This is completely unacceptable and patients are suffering. @US_FDA please act with true urgency and halt the iPLEDGE program immediately.

💥Media alert💥 @SyneosHealth @fda has completely wrecked patient access to isotretinoin. Ask local dermatologists. Patients cannot get meds. Physicians wait hours on hold without help. Disaster. @NBCNews @CBSNews @abcnews @CNBC @AmerMedicalAssn @AADskin @AADmember #iPLEDGE

Why @US_FDA needs to immediately halt the iPLEDGE REMS program to address the rollout failure of the new platform by @SyneosHealth, a thread: #dermtwitter #isotretinoin #iPLEGEfailure 1/9

and Patients who need this drug for a variety of reasons are now the ones being harmed. @US_FDA and @SyneosHealth, please suspend this program until the basic tools are up and running again so patients can get care they need. 4/4

Even if it were up and running, new #Accutane REMS program workflow and rules from @SyneosHealth is unworkable for patients and physicians. This was predicted by dermatology community, but regulators and contractor moved ahead. 3/4

and #Accutane isn't just for Acne. Also prescribed to prevent skin cancer in transplant patients, treat severe genetic childhood diseases (lamellar ichthyosis), etc. Patients being sent home across the country without their refills, many locked out of system for a month. 2/4

#Accutane has basically been pulled from market by utter incompetence of @SyneosHealth hired by @US_FDA to administer risk mgmt program. #Dermatologists warned this would happen. Patients unable to get drug. Website crashed. Help line has 6 hr hold times. No fix in site. 1/4

Media alert🔥🔥 @SyneosHealth @SyneosComms has completely destroyed Dermatologists ability to prescribe isotretinoin to patients. Our hands are tied. #patientssuffer #ipledge @US_FDA

@SyneosHealth @SyneosLearn @SyneosComms How can you advertise your company as able to execute complicated organizational pharm solutions? The Ipledge disaster today shows that you and @fda are absolutely incompetent in this regard

@NolaStreet M

We reached 100 followers. Everyone who likes and retweets this post with a comment of their shirt size will get a chance at a FREE Tchoupa style shirt in time for the first playoff game...

@JeffDuncan_ *Suri

Last giveaway! Go big or go home. Or to Miami. 🌴 RT by 3 p.m. to enter for our last signed jersey, then vote like crazy! #VoteKB #VoteX

@LSUgym y'all must be doing something right...my daughter doesn't want to come home tomorrow. 🤸‍♂️

Double rainbow @wwltvweather

@Cubs In town from New Orleans...let's heat up the bats and fly the W tonight!!

@TheJudge44 Tonight u took a moment to tell a young fan hello. U took a pic/signed his hat. What a great role model😊#classact #newJudgefan