Audit of Issues Related to the Food and Drug Administration Review of Bovine Somatotropin, A-15-90-

Memorandum Richard P. Kusserow Audit of Issues Related to the Food and Drug Administration Review of Bovine Somatotropin (A-15-90-00046) James 0. Mason, M.D., Dr. P.H. To Assistant Secretary for Health The attached final audit report presents the results of ouraudit of the Food and Drug Administration's (FDA) review ofWe conductedthis audit at the request of Congressman John D. Conyers, Jr.,House Committee on Government Operations, who wasconcerned about: in milk from cows treated with theof and (3) the possibility that FDA and MonsantoAgricultural Company (Monsanto), one of the drug developing withheld, suppressed, and manipulated health-related data.Our review focused on FDA's procedures in evaluating related data, We found that research has been conducted todemonstrate both that is not harmful to humans, and that levels in milk are not higher in cows than inOur review also showed that FDA andnon-treated cows. Monsanto have appropriately withheld animal health data on but FDA has publicly disclosed the data it reviewed onwe found no evidence indicatinghuman food safety. that FDA or Monsanto engaged in manipulation or suppression of test data.As to public statements made by FDA officials regarding thesafety of and the likelihood of its approval, we conferredwith the Department of Health and Human Services', Office ofGeneral Counsel, violate law or regulations. However, we believe that FederalGovernment ...