FDA Orders REMS Modifications for iPLEDGE

Dec 5, 2023 | Blog, Uncategorized

Following a period of open comment, public advisory committee meetings, and closed-door deliberations, FDA is mandating changes to iPLEDGE, the Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin for acne. The Isotretinoin Product Manufacturers Group (IPMG) has 180 days to implement the required changes, many of which have been championed by isotretinoin prescribers and by professional organizations like the AARS and the American Academy of Dermatology Association (AADA), among others.
As outlined in a letter to the IPMG, the FDA is requiring that iPLEDGE:
• 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 in conjunction with measures to minimize falsification of pregnancy tests.
• 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 isotretinoin treatment initiation, a repeat confirmatory test must be completed in a medical setting (as described above) without any required waiting period.
• Revise the registry requirement to remove the objective to document the outcome (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. Before dispensing each prescription, the authorization to dispense must verify patient enrollment and prescriber certification.
Previous changes to iPLEDGE classified patients as able to become pregnant or not able to become pregnant but still required ongoing counseling about fetal risk to patients in the latter group. Reducing counseling to the time of enrollment for patients who cannot become pregnant will minimize time demands for prescribers.
Use of at-home pregnancy tests was introduced to iPLEDGE with the rise of teledermatology during the COVID-19 public health emergency. However, without a formal change to the REMS, home testing would have been eradicated.
The 19-day lock-out period had been particularly controversial, as detractors noted that the requirement did not correlate with observed patterns of fetal exposure to isotretinoin.
Commenting after the conclusion of a joint meeting of the FDA Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting at which she spoke this spring, AARS President Andrea Zaenglein, MD, called the 19-day lockout an “excessively punitive requirement.” She said the restriction, “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.”
Implementation of iPLEDGE changes had been anticipated, given that a majority of advisory committee members had 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. However, the committee vote and recommendations are non-binding.
With this decision, the FDA has enacted the recommendations of the committee.



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