Are fixes in sight?
On Tuesday, Dec. 14, AADA President Kenneth J. Tomecki, MD, issued a statement expressing disappointment about the transition.
AAD
Dr. Kenneth J. Tomecki
“In advance of this transition, the AADA engaged the FDA and the iPLEDGE administrator, Syneos Health, about the numerous workflow concerns raised by dermatologists and how the impending changes would threaten patient access to necessary medication. Those concerns have become a reality across the country and we’re working to ensure patients can maintain safe and appropriate access to the treatment they need.”
The AADA, the statement continues, supports efforts to streamline the program while keeping patient safety and incorporating input from physicians.
“We are very aware of the problems with the implementation of the iPLEDGE program,” FDA spokesperson Charlie Kohler said in an email. “We are continuing to work closely with the isotretinoin manufacturers to ensure that they implement a smoothly functioning iPLEDGE REMS program and that patient care is not interrupted.”
“Syneos Health appreciates the concern about iPLEDGE,” said Gary Gatyas, a spokesperson for Syneos Health. “While Syneos Health does not maintain the iPLEDGE system or contact center, we are doing what we can to help the responsible parties with a resolution.” Meanwhile, he recommended that people contact the call center.
He did not respond immediately to questions about who is responsible for maintaining the system and call center.
Dr. Goldberg, Dr. Frieden, and Dr. Yeung have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.