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July 2015

We Pledge to Change iPLEDGE

Author Affiliations
  • 1Division of Dermatology, University of Vermont Medical Center, Burlington
  • 2Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
  • 3Division of General Internal Medicine, University of California, Davis Medical Center, Sacramento
JAMA Dermatol. 2015;151(7):701-702. doi:10.1001/jamadermatol.2015.0736

The US Food and Drug Administration’s mandatory pregnancy prevention program iPLEDGE has the noble intention of reducing the incidence of exposure to the teratogenic acne medication isotretinoin during pregnancy. Unfortunately, it is not working. Nearly a decade into the iPLEDGE era, the pregnancy rate among isotretinoin users is no lower than it was under the prior program, SMART (System to Manage Accutane-Related Teratogenicity); it is estimated that 2.7 isotretinoin-exposed pregnancies occur per 1000 treatment courses.1 Our country can do better, and we propose overhauling iPLEDGE in 2 areas: (1) by emphasizing the relative effectiveness of contraceptive measures for the target audience, women of child-bearing potential, and (2) removing other requirements that do not contribute to the mission of the program.

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