FDA issues required iPledge REMS modifications to isotretinoin manufacturers

Key takeaways:

• The FDA has issued a notification to isotretinoin manufacturers to modify the iPledge Risk Evaluation and Mitigation Strategy.
• Modifications are dedicated to minimizing burdensome protocols and maintain safety.

The FDA has issued a notification to isotretinoin manufacturers to modify the iPledge Risk Evaluation and Mitigation Strategy to minimize procedural burdens on prescribers, pharmacists and patients.

To prevent fetal exposure of isotretinoin, the iPledge Risk Evaluation and Mitigation Strategy (REMS) was implemented as a way to keep prescribers, pharmacists and patients informed about the drug’s serious risks and safe-use conditions.

On Nov. 30, isotretinoin manufacturers were instructed to implement modifications to the iPledge REMS. According to the FDA, these modifications will minimize the burden on patients, pharmacies and prescribers while maintaining the safety of isotretinoin use.

Modifications include:

• no longer requiring pregnancy tests be performed in a specially certified laboratory, and instead allowing home pregnancy tests during and after treatment with prescribers taking steps to minimize patient falsification;
• removing the required waiting period for patients if they do not obtain isotretinoin within the first 7 days of receiving the prescription, and instead requiring a repeated confirmation pregnancy test in a medical setting before initiating treatment;
• no longer requiring pregnancy and fetal outcome documentation; and
• only requiring documented patient counseling at enrollment vs. monthly for patients who cannot become pregnant.

These determinations were based on advice from the March 2023 Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee meeting as well as public feedback. The manufacturers are required to submit proposed REMS modifications to the FDA within 6 months.