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Executive Summary

Fraudulent applications can be replaced "only by means of new applications," FDA's proposed fraud policy states. Published in the Dec. 21 Federal Register, the proposal applies to generic and brandname drugs, biologics, medical devices, veterinary drugs and foods. FDA will refuse to approve a pending application that contains fraudulent data "regardless of the applicant's attempt to submit valid replacement data," the proposed policy states. In a new application, the agency will permit the submission of data from the old submission "to the extent that the data can be demonstrated and are certified to be valid." The policy adds that the new application should identify the sections of the original application that were determined to be false. The accuracy of the information in the new application will have to be "certified by the president, chief executive officer, or other official most responsible for the firm's operations," the policy emphasizes. The proposal also states that FDA will initiate withdrawal proceedings for approved applications that are found to contain fraudulent data or information "regardless of whether the applicant submits new data or information to replace the false submissions," the proposal states. Publication of the fraud policy was expected in early October ("The Pink Sheet" Oct. 8, T&G-7). Many elements of the policy already have been implemented, the document says. Comments on the proposal must be submitted by Jan. 22. The policy points out that if FDA has a significant question about the validity of an application's data and information, the agency "will notify the applicant and provide an opportunity for the applicant to resolve the validity issue." Should FDA find that the data are reliable, "the submission will return to the review queue." In the case of ANDAs, the agency plans to return the filing to "the review queue in the position it occupied at the time of the removal from the review queue, minus the time required for the agency's validity determination." The notice adds that this part of the policy will be "described more fully" in an upcoming Office of Generic Drugs policy and procedure guide. The policy also outlines the corrective actions that a firm engaging in fraud, false statements or bribery will have to take to establish the reliability of data in pending applications and to support the integrity of marketed products. Such a firm will have to cooperate with FDA and other investigations to determine the reason and scope of any "improprieties." The firm will have to "identify all individuals" involved in the improper acts or convicted of an FD&C Act violation, and remove those individuals from positions of authority on FDA-related matters. Additionally, the firm will be required to conduct an "internal review" to identify all instances of fraud, false information, or any discrepancy in pending or approved applications. The review should involve a qualified outside consultant, and the results must be sent to FDA for verification. An internal review is meant to supplement FDA's ongoing investigation of the firm. The firm also will be required to submit "a consent decree or agreement" signed by the CEO that will commit the company to an operating plan that will "assure the quality, safety and integrity of its products." FDA will then inspect the firm to check on the internal audit and to see that the new operating plan has been implemented. FDA noted that it may seek product recalls and ask for new tests of "critical products," including drugs that are difficult to manufacture or that have narrow therapeutic ranges. The viability and legality of many of these measures was challenged by D.C. attorney Alan Kaplan (Kleinfeld, Kaplan & Becker) at a Dec. 11 Food & Drug Law Institute meeting ("The Pink Sheet" Dec. 17, T&G-5).

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