The IPledge Risk Evaluation and Mitigation (REMS) program was designed to address the significant potential for serious birth defects should a pregnancy occur during treatment with the drug isotretinoin which is used to treat acne. The program covers both males and females, since isotretinoin can be passed through the semen of males if the male is being treated with the drug.
In October of 2021, the FDA announced that they approved a modification to the IPledge REMS program (here) and ever since the modification went into effect, there have been problems with its implication through the IPledge website. Recently, the FDA announced that they will use flexibility in enforcing the REMS elements. The FDA has asked the manufacturers that share the program through the Isotretinoin Products Manufacturers Group (IPMG) to develop solutions to address the ongoing problems being encountered in the operation of the IPledge website to assure that patient’s therapy is not interrupted while maintaining the requirements of the REMS program. The current announcement can be found here.
