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Executive Summary

FDA PRODUCT REVIEW POLICY FOR NDAs/ANDAs OF SUSPECT "INTEGRITY" will be published within the next week or two in the Federal Register. FDA Acting Commissioner James Benson referred to the proposed policy in a Sept. 21 letter to House Energy & Commerce/Oversight Subcommittee Chairman John Dingell (D-Mich.). Benson's letter was a response to a Sept. 14 letter from Dingell concerning the agency's suspension of reviews of all American Cyanamid new animal drug applications following FDA's discovery of possible clinical data manipulation. In that letter, Dingell asked why FDA had not adopted a policy for suspending reviews of human drug applications of firms involved in fraud or corruption until the companies in question could assure the validity of the data. Benson told Dingell that the "same policy has been in force throughout the generic drugs investigation." He added that while FDA currently has no statutory authority to prevent sponsors from receiving product reviews and approvals, the agency is developing "a new compliance policy." The new policy represents "an effort to elucidate for the benefit of all FDA-regulated industries the regulatory measures the agency may employ when the integrity of the data in product applications is undermined," Benson said. "This proposed policy will set forth the conditions under which the agency will defer both product approvals and substantive data reviews." The new compliance policy also will tell firms how to "rehabilitate" tainted applications. The FDA official added that the purpose of the deferrals "would be to ensure that the data in pending applications are valid prior to the agency's reliance on the data to determine safety and efficacy after fraud and/or improper conduct such as payment of illegal gratuities has occurred."

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