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FDA TO BARR: AGENCY HAS "INADEQUATE" AUTHORITY TO WITHDRAW ANDAs

Executive Summary

FDA TO BARR: AGENCY HAS "INADEQUATE" AUTHORITY TO WITHDRAW ANDAs as punishment for firms that paid illegal gratuities to FDA reviewers, former FDA Commissioner Young said in a Dec. 15 letter to Barr's Washington, D.C.-based law firm Bishop, Cook, Purcell, and Reynolds. Young was responding to Barr's June 14 petition requesting that FDA withdraw ANDAs obtained during periods when illegal payments to FDAers were confirmed ("The Pink Sheet" June 19, p. 6). The response was one of the last acts taken by Young before leaving the agency to become a deputy assistant secretary at HHS on Dec. 18. In the letter, Young explained that FDA was denying Barr's request to withdraw ANDAs as punishment for firms guilty of illegal gratuities given (1) that FDA has "no evidence tying illegal gratuities to any specific ANDAs or that illegal gratuities resulted in unsafe or ineffective drugs being marketed, our legal authority to base withdrawals on such gratuities is inadequate;" (2) "that the more serious potential public health problems resulted from other misdeeds;" and (3) "that FDA's resources were focused on inspections and safety reviews." However, Young "emphatically" agreed in principle with Barr's reasoning "that wrongful acts should not be rewarded by the Federal government." He continued: "For that reason, I have decided that your petition should be granted to the fullest extent possible, within the limitations of our legal authority and our resources." Barr's citizen petition, submitted last June 14, initially asked FDA to withdraw the ANDAs of those firms that allegedly paid illegal gratuities to FDA employees. The first companies named in the petition were Par, Quad, Pharmaceutical Basics, and American Therapeutics. Barr subsequently amended the petition in the following months as the generic scandal widened to include companies that allegedly falsified information in ANDA submissions, adding the names of Vitarine, Quantum and Bolar to the list. Young indicated that the "intent" of the Barr petition "can be satisfied," given the agency's legal constraints, by following FDA's current course of action. First, he said, "generic drugs that have been found to lack assurance of quality and bioequivalence have been recalled" and "where conditions of approval were not fully complied with, production and distribution of products have been suspended." Second, ANDA approvals of some firms, Young noted, "are being more carefully reviewed pending further FDA investigations of the applicants' activities and procedures." Third, Young said, FDA has conducted re-reviews of certain ANDAs "to assure ourselves and the public that those applications were properly approved and that those drugs are fully safe and effective." Fourth, FDA has inspected "over 30 generic firms" checking procedures for recordkeeping, manufacturing, and quality control. Fifth, Young continued, FDA has initiated withdrawal proceedings for ANDAs "covering more than 30 drugs" in response to "fraud and misrepresentations we have discovered so far." Sixth, Young noted that criminal charges have been filed against several executives of generic companies for giving illegal gratuities to FDAers and that several of them have been sentenced. Finally, Young pointed out that FDA and HHS "are working to develop a legislative proposal to clarify and strengthen the department's authority."
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