The long-awaited modifications for the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) system for the teratogenic acne drug isotretinoin, previously scheduled to go into effect August 8, 2026, will be delayed until November 15, 2026, the FDA announced on June 16.

The extra time is meant to allow testing of the iPLEDGE REMS system updates, minimize technical issues for users of the platform, and help ensure patients have uninterrupted access to the treatment, according to the FDA.

The modifications, described in February 2026 in an agency update, are meant to minimize the burden on pharmacies, prescribers, and patients while maintaining the safe use of isotretinoin. It allows for at-home pregnancy tests in some cases, among other changes.

Until the November date, the FDA will continue to exercise enforcement discretion on pregnancy testing requirements, as detailed in an FDA update in October 2023.

Safety First

“It’s important to make sure any changes to the program are implemented in a way that is effective,” John Barbieri, MD, MBA, associate professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital, Boston, told Medscape Medical News.

As the chair of the iPLEDGE work group, which works with the FDA and the Isotretinoin Products Manufacturing Group (IPMG), Barbieri has long supported and advocated for the modifications.

“I would rather it be done sooner than later,” Barbieri said of finalizing the modifications, “but it’s important it be done right.”

He pointed to the difficulties encountered in 2021, when a change in the website vender produced numerous glitches, making access to the platform and to obtain the medication impossible for some patients.

Barbieri reiterated his willingness to work with the FDA and the IPMG to help with the process, which, he told Medscape Medical news,he has offered numerous times in the past. “This is already years overdue,” he said of finalizing the long-awaited modifications.

iPLEDGE: A Short History

The iPLEDGE program was introduced in 2005 and approved as the iPLEDGE REMS in 2010, with the goal of minimizing fetal exposure to the teratogenic drug, which is approved for treating severe recalcitrant nodular acne in patients aged 12 years or older. It is referred to as a “shared system” REMS, including all FDA-approved isotretinoin products. There is a centralized system for prescribers, pharmacies, and patients to manage patient risk, whichever product is used.

The modifications are outlined in a November 2023 FDA notification to isotretinoin manufacturers, which says that the requirement that pregnancy tests be performed in a CLIA-certified lab will be removed, but that prescribers must continue to complete pretreatment pregnancy tests in a medical setting before starting treatment.

Then, the modifications allow major changes:

• A prescriber may allow patients to do pretreatment pregnancy tests outside the medical setting, such as at home, during and after treatment. Prescribers who allow this must establish processes and procedures to minimize misinterpretation and falsification of tests allowed outside a medical setting.
• If a person capable of getting pregnant does not pick up a prescription within the 7-day window, another test may be done immediately without an additional waiting period, eliminating what was referred to as the 19-day lockout.
• If a patient has not yet received a first dose and does not pick up the prescription within the 7-day window, the repeat test must be done in a medical setting.
• Those who cannot become pregnant must be counselled at enrollment, with ongoing reinforcement. Monthly documentation of counseling of these patients is no longer required.
• Pharmacies no longer have to have a 30-day window for those who can’t get pregnant.
• Clarifying language was added to say that pharmacy staff training is required annually, and records of that training should be maintained by the certified pharmacy’s authorized representative.

The expert cited in this article had no relevant disclosures.