FDA is aware that patients, prescribers, and pharmacies are experiencing difficulties with the implementation of the modified iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program, including the inability of many participants to log in to the website or long call center wait times, resulting in disrupted access to treatment for many isotretinoin patients. We understand and share the frustration caused by these challenges and are urging the isotretinoin manufacturers to develop and implement a workable solution as soon as possible.
REMS are drug safety programs that are required for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. While FDA determines the need for a REMS, FDA does not run the REMS programs. The responsibility for implementing the iPLEDGE program and making sure that it works as intended rests with the manufacturers, known as the Isotretinoin Products Manufacturers Group (IPMG).
A REMS is required for isotretinoin because it carries a high risk of fetal injury, severe birth defects, and pregnancy loss if taken by people who are pregnant. The iPLEDGE REMS program was developed following years of other risk management programs which failed to prevent fetal isotretinoin exposure, resulting in high numbers of exposed pregnancies in patients taking isotretinoin.
Given the magnitude of the issues that iPLEDGE participants are currently facing, FDA has communicated to the IPMG a potential temporary solution to support isotretinoin patients during the transition to the new iPLEDGE website and we have been prompting the IPMG to work with prescribers and pharmacies to put in place this temporary solution as quickly as possible.
FDA is ready to exercise regulatory flexibility on a temporary basis as needed with regard to certain requirements of the iPLEDGE REMS, provided the IPMG proposes a workable solution that also ensures necessary safe use conditions are maintained.
We have strongly encouraged the IPMG to work with the American Academy of Dermatology Association and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition to the modified iPLEDGE program.
FDA will monitor and review the IPMG’s progress in exploring, developing, and implementing a reasonable solution, and will continue to update all iPLEDGE stakeholders on any action to address the current problems with the iPLEDGE website and call center.