FDA agrees to implement AADA’s iPLEDGE recommendations

The FDA agreed to require significant Academy-recommended changes to the iPLEDGE program that will alleviate administrative burdens for dermatologists. 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.

In 2023, 300 Academy members sent about 600 messages to the FDA urging changes to the iPLEDGE Program. These grassroots efforts, combined with the 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 Program that would minimize burdens on patients and dermatologists while maintaining the safe use of isotretinoin. 

The FDA will require the Isotretinoin Product Manufacturers Group (IPMG) to implement the following changes to the iPLEDGE program:

• Remove the waiting period requirement (or the 19-day lockout) for patients if they do not obtain isotretinoin within the first seven-day prescription window. Before initiating isotretinoin treatment, a repeat confirmatory pregnancy test must be completed in a medical setting 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. 

The isotretinoin manufacturers will be required to implement these changes six months from the date of the FDA’s notification. Then, the FDA has six months to review and approve the changes. Therefore, these changes may take up to a year or more to be fully implemented. 

The AADA has already requested to participate in the next phase of this process and will continue to advocate for other iPLEDGE program recommendations. Learn more about the Academy’s iPLEDGE advocacy efforts.