iPLEDGE

The iPLEDGE program is a program by the U.S. Food and Drug Administration (FDA) for managing the risk of isotretinoin (also known as Accutane), a prescription medication used for the treatment of acne. Patients, their doctors and their pharmacists are required by the FDA to register and use the iPLEDGE web site in order to receive, prescribe or dispense isotretinoin. Isotretinoin carries a high risk of causing severe birth defects if taken during pregnancy (see Teratogenicity of isotretinoin) and the goals of the iPLEDGE REMS (risk evaluation and mitigation strategy) program are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin's serious risks and safe-use conditions. The program was designed by the Isotretinoin Product Manufacturers Group (IPMG) and its chosen vendor, Covance, under the direction of the FDA and went live on March 1, 2006. The program has not significantly reduced exposure of pregnant people to the drug in comparison to the previous SMART program, and has been criticized for being overly complicated and difficult for prescribers, pharmacists and patients to navigate successfully.