A Safer System For Prescribing A Dangerous Drug

The Food and Drug Administration (FDA) last week tightened restrictions on the prescription acne medication Accutane (isotretinoin) and its generic equivalents. The drug has long been known to cause birth defects, and in 2002, Accutane's manufacturer, Roche, had put a program in place to further limit fetal exposure. But now the FDA says that program, along with several similar efforts to restrict use of the generic equivalents, created confusion and failed to protect pregnant women and their embryos. Under the new measures, manufacturers will register doctors who prescribe the drug, pharmacies that dispense it and patients who take it. Patients must be informed of the drug's risks and provide their informed consent. Women of childbearing age will also have to show proof that they have taken a pregnancy test.