The FDA “is ready to exercise regulatory flexibility on a temporary basis as needed”

The FDA has asked manufacturers responsible for implementation of the modified iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program to work with impacted stakeholders including pharmacy organizations to identify solutions to minimize problems. This move follows serious concerns voiced by SDPA members and other healthcare providers who experienced glitches and extensive wait times while attempting to use the modified system. Because patient care was negatively impacted, concerned SDPA members engaged in a congressional writing campaign to ensure the issue was understood by lawmakers. More than 1,500 SDPA members wrote letters to members of Congress.

According to the FDA, the responsibility for implementing the iPLEDGE program and making sure it works as intended rests with the manufacturers, known as the Isotretinoin Product Manufacturers Group (IPMG).

While glitches are being addressed, the “FDA is ready to exercise regulatory flexibility on a temporary basis as needed with regard to certain requirements of the iPLEDGE REMS, provided the IPMG proposes a workable solution that also ensures necessary safe use conditions are maintained,” a statement released by the FDA said.

The FDA has urged IPMG to work with the American Academy of Dermatology Association and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition to the modified iPLEDGE program.

The FDA’s full statement is available here. SDPA will continue to monitor the situation and will collect additional comments from its members.