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Executive Summary

FDA's request for dismissal of Barr's complaint that agency officials had illegally disclosed proprietary information regarding the generic firm's conjugated estrogens ANDA was denied by Washington, D.C. Federal Court Judge Royce Lamberth on March 8. Judge Lamberth, a former Justice Department attorney who is familiar with FDA cases, said that FDA is no longer entitled to a "presumption of regularity" following revelations from the generics investigation that some agency employees passed on trade secret information to competitor companies. In fact, Barr presented as evidence Charles Chang's affidavit to Rep. Dingell's oversight subcommittee in which the former FDA employee admitted to passing on trade secret information to American Therapeutics. Barr's complaint, filed in November 1988, alleges that confidential information in Barr's ANDAs supporting an "AB" rating for conjugated estrogens based on urinary excretion studies was passed on to Wyeth-Ayerst, the manufacturer of the brandname product Premarin ("The Pink Sheet" Dec. 12, p. 10). Barr maintains that as a result of the information, Wyeth-Ayerst was able to successfully argue that blood level studies, instead of urinary excretion studies, should be required to prove bioequivalence. Judge Lamberth considered an HHS Inspector General report on an investigation conducted to determine whether FDA employees had leaked information to Wyeth-Ayerst. The report, prepared by HHS IG Special Agent Frank Adelman, states that the investigative efforts "did not uncover evidence supporting the allegations." Barr contends that Wyeth-Ayerst learned of data supporting its ANDA submission from unknown FDA employees. In response to the IG report, Barr referred to the statement of Justin Victoria, director of regulatory affairs for Wyeth-Ayerst. Barr noted that Victoria said he found out the identities of two consultants to the generic company involved in the ANDA submission from the Office of Drug Standards Special Assistant Donald Hare. In his statement to the IG investigator, Hare said that he did not disclose the identities to Victoria. The IG report suggests that Wyeth-Ayerst learned of the ANDA submission and its contents from Barr's application to the New Jersey formulary in February 1988.

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