AARS Alert: FDA Open Comment Period

FDA Committees Vote in Favor of Ending 19-Day Lockout, Revising Attestations for iPLEDGE

Modifications aimed at enhancing patient access and minimizing administrative burdens for physicians and patients may be coming to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program for isotretinoin.

At the conclusion of a joint meeting of the U.S. Food and Drug Administration (FDA) Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting last month, a majority of committee members voted in favor of ending the 19-day lockout for patients who can become pregnant and for eliminating the need to document monthly counseling for patients who cannot become pregnant. The vote is non-binding, although FDA historically follows the recommendations of such committees.

In addition to voting on the lockout and counseling requirements, committee members explored the potential to permit the use of non-Clinical Laboratory Improvement Amendments (CLIA)-certified pregnancy testing with iPLEDGE and discussed potential enhancements to the existing pregnancy registry aimed at improving data gathering and analysis.

Representing the American Acne and Rosacea Society (AARS) during the public comment period of the meeting, AARS President Andrea Zaenglein, MD and AARS Director Emmy Graber, MD, advocated for removal of the 19-day lockout, removal of the 30-day waiting period for patients already on long-acting reversible contraception, the use of home pregnancy testing, and enhanced patient education regarding emergency contraception.

“I am very grateful that the FDA allowed for these presentations by me and other dermatologists,” Dr. Graber says. “I appreciate their willingness to listen to our viewpoint. Going forward, I hope that there is further conversation and would welcome a two-way dialogue with members of the committee.”

Calling the 19-day lockout an “excessively punitive requirement,” Dr. Zaenglein notes that, “it does not decrease risk of pregnancy but simply prolongs waiting periods for patients who miss the 7-day window period to pick up their medication, often due to no fault of their own. We are pleased that the majority of FDA panel members recognized the burden that the lockout imposes on patients who already waited 30 days to start treatment and voted in favor of eliminating the 19-day lockout.”

Only one member of the committees voted in favor of maintaining monthly attestation for patients who cannot become pregnant. Nearly half of voters favored no attestations beyond the time of therapy initiation. The remaining votes were split between attestation every 120 days or repeat attestation at an interval to be determined.

“Removing monthly attestation would be a tremendous relief of administrative burden for providers. Hopefully, the panel will not dictate a specific timeframe for repeat attestation or counseling and allow for flexible scheduling of these patients based on provider judgment,” Dr. Zaenglein says. “As isotretinoin is slow-acting and subject to 30-day supply limits, drug diversion is not a major concern with very few reports provided by the IPMG. Additionally, blood donation centers stringently screen donors for isotretinoin use during their intake, greatly minimizing this risk.”

IPMG is the Isotretinoin Products Manufacturers Group, which is required by FDA to fund the iPLEDGE REMS. The REMS is administered by UBC on behalf of the IPMG.

No vote was held regarding the use of non-CLIA certified pregnancy testing, though robust discussion was held. Comments did not reveal substantial objection to such testing, though committee members seemed to generally agree that more data should be collected to help support a future decision. Committee members seemed to demonstrate greater skepticism regarding the use of at-home testing in the context of telemedicine after the COVID public health emergency period. Discussion focused on potential for falsifying tests, although several dermatologists in clinical practice shared strategies aimed at mitigating such risks.

The joint committee meeting also included discussion of the iPLEDGE pregnancy registry, with an eye toward the potential to expand data collection and analysis. Several committee members noted that it is unclear whether there is active recruitment to the registry or whether modifiable burdens may hinder participation.

In closing, committee members shared additional thoughts on potential improvements to the iPLEDGE program. Multiple comments focused on a need to open lines of communications between stakeholders and IPMG.