The American Academy of Dermatology (AAD) announced that the FDA has agreed to its recommended changes to the iPLEDGE patient safety program. The AAD noted that the iPLEDGE program was designed to inform patients of the risks and safe practices of receiving isotretinoin; however, the program may also increase burdens on patients and dermatologists. After the AAD’s members and advocacy group sent over 600 messages to the FDA regarding modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program, the FDA issued a letter to the Isotretinoin Product Manufacturers Group to implement the changes. The manufacturers of the drug will be required to make the necessary adjustments within 6 months of their receipt of the FDA’s letter, which will then be reviewed in the subsequent 6 months. “Because of the AAD’s relentless advocacy over 2 years, the FDA has finally agreed to require much-needed changes to the … iPLEDGE [program], reducing administrative burdens in dermatology care and helping patients get access to their treatments in an easier manner,” concluded Terrance A. Cronin, Jr, MD, FAAD, President of the AAD.
Among the AAD’s recommended changes were:
- Eliminate the waiting period for patients if they do not obtain isotretinoin within 7 days of prescription and those required to take a repeat confirmatory pregnancy test in a medical setting
- Allow the continued use of at-home and non–Clinical Laboratory improvement Amendments pregnancy tests
- Omit the requirement to document pregnancy and fetal outcomes for each pregnancy
- Require documentation of patient counseling among those unable to become pregnant only at enrollment.