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CERTIFICATION STATEMENTS REQUIRED BY GENERIC DEBARMENT LEGISLATION

Executive Summary

CERTIFICATION STATEMENTS REQUIRED BY GENERIC DEBARMENT LEGISLATION should be submitted to FDA before Dec. 1, 1992 for applications filed after June 1, 1992, FDA Office of Compliance Director Daniel Michels advised pharmaceutical firms in a July 29 letter. Directed at "all NDA, [PLA], ANDA, AADA, and export application holders and applicants," Michels' letter states that "in order to avoid delays in agency action on drug product applications, I request that you amend, no later than Dec. 1, 1992, any pending [applications] received by FDA on or after June 1, 1992 that do not contain these documents." Michels urged prompt amending of export applications by sponsors since FDA is required to act on such applications "in a shorter period of time" than other filings. "I request that you immediately amend any pending applications submitted on or after June 1, 1992, and that you submit the appropriate certification statements in all of your future applications," Michels told export application holders. The cover letter introduces a July 27 interim guidance signed by FDA Deputy Commissioner for Operations Jane Henney, MD, to the drug industry on implementation of certification and information provisions of the Generic Drug Enforcement Act, which went into effect on June 1. The provisions of the Act require manufacturers to certify that they have not used the services of debarred individuals or firms ("The Pink Sheet" July 20, p. 7). The interim guidance informs companies that "FDA has not yet debarred any individual or firm" and that "any order debarring an individual or firm will be published in the Federal Register." In addition to the notices, a publicly available list of debarred individuals and firms will be maintained by the Office of Regulatory Affairs, the guidance states. Under the debarment law, generic firms have an additional requirement to certification. Generic companies must submit "a list of all convictions, for which a person can be debarred, of the applicant and affiliated persons responsible for the development or submission of the application," the interim guidance notes. This includes any persons associated with data submission, manufacturing, and bioequivalence testing of a product.
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