iPLEDGE Win: FDA implements AADA’s recommendations

In response to AADA’s relentless advocacy, the FDA has finally agreed to implement important changes to the iPLEDGE program that will alleviate administrative burdens for dermatologists.

In 2023, 300 AADA members sent about 600 messages to the FDA urging changes to iPLEDGE REMS Program. These grassroots efforts, combined with AADA’s strong advocacy led by its iPLEDGE Workgroup, including testifying during an FDA hearing in March, convinced the FDA to require modifications to the iPLEDGE REMS to minimize burdens on patients and dermatologists while maintaining the safe use of isotretinoin. The FDA will require the iPLEDGE Isotretinoin Product Manufacturers Group (IPMG) to implement the following changes to the iPLEDGE REMS:

• Remove the waiting period requirement (also referred to as the “19-day lockout”) for patients if they do not obtain isotretinoin within the first 7-day prescription window. Before initiating isotretinoin treatment, a repeat confirmatory pregnancy test must be completed in a medical setting (as described above) without any required waiting period.
• Revise the pregnancy registry requirement to remove the objective to document pregnancy and fetal outcomes (and associated data collection) for each pregnancy.
• Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment.
• Remove the requirement that pregnancy tests must be performed in a CLIA-certified laboratory; however, all pregnancy testing before isotretinoin treatment initiation must be completed in a medical setting (e.g., prescriber’s office, clinic laboratory). Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. As of Nov. 7, 2023, all pre-treatment pregnancy tests must be performed in a medical setting (e.g., office, laboratory).

For more information, visit FDA’s frequently asked questions.

The isotretinoin manufacturers will be required to implement these changes six months from the date of FDA’s letter. Then, the FDA has six months to review and approve the changes. Once approved, the isotretinoin manufacturers will need time to implement the changes. Therefore, these changes may take up to a year or more to be implemented fully. The AADA has already requested to participate in the next phase of this process.

The AADA has been fighting for these changes since 2021 when the FDA transitioned to a new iPLEDGE platform that malfunctioned and disrupted treatment for many patients.