iPLEDGE advocacy

The Academy advocates on behalf of dermatologists and patients for improvements to the iPLEDGE program. 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.

Our advocacy has been on multiple fronts, working with the FDA, manufacturers, and pharmacies. We have lobbied Congress to put pressure on the stakeholders to find solutions that work for dermatologists and patients, while building coalitions with other specialties impacted by similar programs. The Academy has also brought media attention to the issue.

Changes won

The FDA will require the 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 IPMG 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 Academy will continue to work with stakeholders to adopt practical, patient-centered solutions. The iPLEDGE system can and should protect patients without imposing arduous administrative burdens on prescribers and patients alike.

Changes already won and implemented:

• Reinstating calendar functionality

• An enhanced enrollment process

• General prescriber and designee updates

The Academy will continue to work with the FDA, IPMG, and other stakeholders to adopt practical, patient-centered solutions. The iPLEDGE system can and should protect patients without imposing arduous administrative burdens on prescribers and patients alike.