Did IPMG Break Its Pledge to Improve iPLEDGE? Tips to Help You Navigate the New Website
By Dr. Susan Massick Due to the FDA’s concern regarding the high risk of teratogenicity associated with isotretinoin, the iPLEDGE program was introduced by the Isotretinoin Products Manufacturers Group (IPMG) and approved by the FDA in 2005 in an effort to prevent pregnancy and fetal exposure during isotretinoin treatment. Despite concerns raised by clinicians and the AAD regarding the program and its implementation, the FDA approved March 1, 2006, as the mandatory start date for iPLEDGE. i In 2007, the FDA gained the authority to determine which medications would require Risk Evaluation and Management Strategy (REMS) programs to mitigate risks associated with certain drugs. In 2010, the iPLEDGE program was updated to the iPLEDGE REMS program with mandatory participation of all isotretinoin drug manufacturers and mandatory registration of all health care providers and pharmacies in order to prescribe and dispense isotretinoin to patients. ii While th...