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Public Citizen v. HHS

Topic(s): Foods, Drugs, Medical Devices, and Dietary Supplements
Status: closed
Citation: CA No 03-0196 (DDC)
Date Of Involvement: 02/06/2003

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Public Citizen filed a suit against the U.S. Department of Health and Human Services (HHS) because the Food and Drug Administration — a part of HHS — was not requesting public comment on rules regarding patient information leaflets that are distributed with prescription drugs by pharmacists, instead relying on a faulty private sector program that does not give patients the vital drug safety information they need. The agency's refusal to request comment violated a statute passed in 1996. Shortly after we filed suit, the agency agreed to hold a public meeting to solicit public comment.