FDA Against New Restrictions on Accutane
December 12, 2002
U.S. Food and Drug Administration (FDA) officials warned lawmakers at a congressional investigative committee hearing Wednesday that placing new restrictions on Hoffman-La Roche Inc.'s acne medication Accutane may increase illegal Internet sales as well as black market purchases in Mexico. Lawmakers are seeking new limitations on the drug because of its link to severe emotional disorders and birth defects.
Dr. Janet Woodcock, director of the FDA's drug-evaluation center, told members of the House Committee on Energy and Commerce that placing new restrictions on Accutane would "do more harm than good" and may encourage teens suffering from less-severe acne to purchase Accutane online or in Mexico. The drug already features a black box warning (the strongest notice a medication can carry) about psychiatric issues and birth defects.
-- Article Courtesy of InjuryBoard.com
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