Kristine Kucera, PA-C, MPAS, DHS


FDA Panel Votes to Modify Isotretinoin iPLEDGE REMS 

The American Academy of Dermatology Association (AADA) in conjunction with the American Acne and Rosacea Society (AARS) and other stakeholders has been working with the U.S. Food and Drug Administration (FDA) and the Isotretinoin Product Manufacturers Group (IPMG) to enact changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program.  Proposed changes, largely based on prescriber input, are aimed at streamlining the program to reduce burdens on patients and prescribers.

iPLEDGE is provided and funded by IPMG and is administered by UBC.

This week, at a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee, experts addressed ways to improve the iPLEDGE REMS. Members discussed and voted on key changes to the program. The vote and subsequent recommendations are non-binding, but FDA often follows the recommendations of its committees.

  • The committee members sought to balance reducing burden with maintaining safety and preventing fetal exposures to isotretinoin. Overall, their recommendations are aligned with the AADA’s recommendations:
  • Over 75% of the committee voted to remove the 19-day lockout period.
  • Most advisory committee members discussed allowing patients to have access to home pregnancy testing for iPLEDGE after the public health emergency; a need for additional data regarding reliability was noted.
  • Nearly all support non-CLIA pregnancy tests for in-office testing.
  • 73% of the committee members voted to remove the monthly attestation requirement to every 4 months or at the time of enrollment, for patients who cannot become pregnant.
  • Many members were in support of Isotretinoin Products Manufacturers Group (IPMG) having physician and stakeholder representation, including regular meetings with the manufacturers.

Kristine Kucera, PA-C, MPAS, DHS, is Assistant Clinical Professor, University of Texas Southwestern, Medical Center PA Program, Dallas, TX. She is a member of the DEF Advisory Council.


Following AADA advocacy, FDA advisory committees recommend vital changes to iPLEDGE

FDA Panel Votes to Modify Isotretinoin iPLEDGE REMS