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FDA ENFORCEMENT BILL's "SWEEPING AND UNJUSTIFIED SCOPE"

Executive Summary

FDA ENFORCEMENT BILL's "SWEEPING AND UNJUSTIFIED SCOPE" concerns the Pharmaceutical Manufacturers Association and 22 other biotechnology, animal health, food, cosmetics and medical products trade groups, the associations said in a joint June 21 letter to Reps. Waxman (D-Calif.), Dingell (D-Mich.) and other cosponsors of the legislation. Although the associations "strongly support an FDA with the will to use the already substantial enforcement authorities it has under the FD&C Act," the groups contended that "the case simply has not been made for sweeping new legislation." Among signatories to the letter are the Industrial Biotechnology Association, Nonprescription Drug Manufacturers Association, the Cosmetic, Toiletry and Fragrance Association, the Health Industry Manufacturers Association, National Electrical Manufacturers Association and the Grocery Manufacturers of America. The adequacy of FDA's current authorities" has been amply demonstrated in recent weeks by Commissioner Kessler," the letter states. The bill (HR 2597) "was developed and introduced without any hearings or justification. The legislation appears to be based on a misperception that the FDA needs broad new enforcement authorities with respect to all the industries it regulates," the association said. "In fact," the letter continues, "there is no such evidence, pattern or practice to suggest that the proposed authorities contained in HR 2597 are necessary or even appropriate -- or that current FDA authority is somehow insufficient to ensure compliance with the FD&C Act." The associations noted that Congress established "a strong record of need" as the basis for the generic drug debarment bill (HR 2454) before introducing legislation to enhance "FDA's regulatory authority over generic drugs." Beyond the debarment bill, which is based on a "well documented and carefully examined" record of abuses, "we see no evidence to warrant further legislation at this time and look forward to any hearings to help dispel any lingering misperceptions."
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