This Acne Drug Needs Tougher FDA Regulation
Source: Washington Post - Page A18
A Food and Drug Administration official is quoted in the Nov. 19 front-page story “FDA Officer Suggests Strict Curbs on 5 Drugs; Makers Dispute Claims About Health Risks” as saying that five criticized prescription drugs give the agency no “more reason for concern than any other set.”
However, the FDA’s Center for Drug Evaluation and Research concluded in February that prescribing one of those five drugs, the acne drug Accutane (isotretinoin), which can cause birth defects, remains dangerously under-regulated by the FDA.
Despite multiple federal inquiries and hearings, the most recent version of voluntary safety measures by manufacturers has produced no substantial improvement in reported exposures of pregnant women to isotretinoin. More than 120 pregnancies have been exposed in the first year of the new risk-management program — no improvement from the previous system. Moreover, Accutane and its generic forms are available over the Internet.
The March of Dimes has called on the FDA to mandate a single, stringently monitored and restricted program for isotretinoin, like the highly effective system created for thalidomide when it was licensed in 1998. This includes mandatory registration into a single system of patients, clinicians and pharmacists; mandatory education; monthly patient surveys on use and possible pregnancies or other adverse effects; and monthly pregnancy testing for female patients. The FDA has yet to act on this request.
The tragic effects of isotretinoin have been known for more than 20 years, with direct links to miscarriage and severe birth defects. It is time for the FDA to take substantive action.
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