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July 17, 2019

Early Strides for Necessary Data-Driven Improvement in iPLEDGE

Author Affiliations
  • 1The Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York
JAMA Dermatol. 2019;155(10):1111-1112. doi:10.1001/jamadermatol.2019.1247

One of the primary missions of the US Food and Drug Administration (FDA) is to protect public health by ensuring the safety and efficacy of drugs. In an effort to fulfill this goal, the FDA has mandated more than 80 Risk Evaluation and Mitigation Strategy (REMS) systems for various drugs. Although several of these drugs are used in dermatology, dermatologists are probably most familiar with the REMS system for isotretinoin, iPLEDGE, which was implemented in 2006 as the third iteration of such a program for isotretinoin. The FDA outlined the following 2 goals for iPLEDGE: to prevent fetal exposure and to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe use conditions.1 Surprisingly, despite the abundance of publications about the program, there is a lack of evidence as to whether iPLEDGE has achieved the first component of its mission: preventing fetal exposure to isotretinoin. Is iPLEDGE a successful REMS program?