FDA Issues Modifications to iPledge REMS for Isotretinoin Manufacturers

The U.S. Food and Drug Administration (FDA) recently issued a notification to isotretinoin manufacturers to state that they must modify the iPledge Risk Evaluation and Mitigation Strategy (REMS).

Originally implemented in 2005, the goal of REMS was to prevent fetal exposure to isotretinoin, as well as a means to inform patients, prescribers, and pharmacists about the serious risks of isotretinoin and how to safely use it.

On November 30, 2023, the FDA stated that certain modifications need to be made in an effort to minimize the burden on patients, pharmacies, and prescribers, all while still maintaining the safe use of isotretinoin. They added that their decision was based on advice gained from the March 2023 Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee meetings as well as feedback received from the public.

The following modifications are now required:

  1. Pregnancy tests are no longer required to be performed in a specially certified laboratory.
  2. Prescribers are allowed the option of using home pregnancy tests for their patients during and after isotretinoin treatment. If they choose to do so, however, they need to take steps to minimize patients falsifying test results.
  3. Removing the requirement to have the “19-day lockout” waiting period for patients if they do not obtain isotretinoin within the first seven days of receiving the prescription. Instead, they would be required to repeat a confirmation pregnancy test in a medical setting before commencing treatment.
  4. Removing the requirement to document the pregnancy and fetal outcomes (and associated data collection) for each pregnancy.
  5. Removing the requirement for patient counseling in those who cannot become pregnant from monthly to only at enrollment.

The FDA is expecting isotretinoin manufacturers to submit their proposed REMS modifications within six months.


Sign up to receive updates on educational opportunities, complimentary content, exclusive discounts, and more.