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Case Detail


WLF's FDA/DDMAC Watch - In re: DDMAC Oversight of Drug Promotion
(Regulatory Proceeding)
On June 21, 2005, WLF launched its "DDMAC Watch" program to monitor regulation of prescription drug advertising by DDMAC (the Division of Drug Marketing, Advertising, and Promotion), a division of the Food and Drug Administration. WLF charged that DDMAC has been using letters to pharmaceutical companies to advance questionable legal theories and request remedial actions that the agency could not require under the law. WLF inaugurated its program by sending a June 21 letter to DDMAC, demanding that DDMAC withdraw a letter that had criticized a television advertisement run by Eli Lilly and Co. On June 30, 2005, WLF responded to two later warning letters sent by DDMAC (one to Endo Pharmaceuticals, Inc. and one to Dutch Ophthalmic USA) and a warning letter sent by the Office of Compliance and Biologics Quality, another branch of FDA that oversees promotion of biological products. WLF has pledged to respond to every advertising letter sent by DDMAC in the months to come.
Case Status:
Awaiting response.
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