The FDA advisory panel meeting was held to address proposed changes to the iPLEDGE REMS to minimize burden on patients, prescribers, and pharmacies while maintaining safe use of isotretinoin.
With abortion banned or greatly restricted in many states, dermatologists who prescribe isotretinoin and methotrexate said they are anxious about the future.
The latest improvement attempt is a tool created by the Isotretinoin Products Manufacturers Group (IPMG), the manufacturers responsible for the FDA-mandated REMS program.
At a meeting with the FDA, AADA representatives described the severe impact on patient access to treatment that is resulting from the issues with the iPLEDGE rollout.
Dermatologists on Twitter and elsewhere are angry and frustrated, with some calling for a temporary halt to the program until the bugs can be ironed out.