The FDA has announced that physicians or patients planning to prescribe or use Roche's Accutane or a generic equivalent have to register with the manufacturer first. The rule is aimed at preventing pregnant women from taking the drug, which can cause birth defects.
"This stronger program is a major step in protecting against inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin," said Dr. Steven Galson, Director, FDA's Center for Evaluation and Research. "iPLEDGE, using a computer-based and telephone system, will provide health care professionals with the real time information necessary to effectively manage the risks of isotretinoin."
- read this press release for more information