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B-257122 1 (1994-10-19)

handle is hein.gao/gaobablin0001 and id is 1 raw text is: United States GAD General Accounting Office Washington, D.C. 20U48 10461910 Office of the General Counsel, .> , - .. . L .. .... B-257122 Octobec 19, 1994 The Honorable George E. Brown, Jr. Chairman, Committee on Science. Space and Technology House of Representatives The Honorable David Obey House of Representatives The Honorable Bernard Sanders House of Representatives rcJ This is in response to your letter dated April 15, 1994. You asked us to examine alleged conflicts of interest on the part of three Food and Drug ^,_Administration employees in the approval of Monsanto's Posilac and the ( related issuance of voluntary milk labeling guidance. You also asked that we determine whether any FDA employees involved in the approval 'of Posilac had an appearance of the loss of impartiality because of a prior relationship with Monsanto. To conduct our investigation, we reviewed more than 40,000 pages of documents; conducted 54 interviews with current and former FDA and Department of Health and Human Services employees, attorneys. Monsanto officials, and editors of scientific Journals; reviewed the financial disclosure and conflict-of-interest statements of all Center for Veterinary Medicine employees who played a significant role in Posilac's approval, and reviewed the relevant ethical standards. On the basis of our review of the law, examination of documents and interviews, we conclude that there were no conflicting financial interests with respect to the drug's approval or the voluntary milk labeling guidance. With respect to the approval of Posilac, we noted only one minor deviation from now-superseded FDA regulations. Finally, with respect to Monsanto's application for Posilac, we identified several

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