Audit of Issues Related to the Food and Drug Administration Review of Bovine Somatotropin

EXECUTIVE SUMMARY:

Our audit of the FDA's review of the new animal drug bovine somatotropin (bST) found that research was conducted to demonstrate both that bST is not harmful to humans, and that bST levels in milk are not higher in bST-treated cows than in non-treated cows. Our review also showed that FDA and Monsanto appropriately withheld animal health data on bST, but FDA publicly disclosed the data it reviewed on human food safety. The FDA concurred with our recommendation that the Commissioner of FDA develop policies and procedures on the type of public statements that can be made regarding a new animal drug undergoing review.

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