Follow-up Review of Possible Improper Pre-Approval Promotion Activities

EXECUTIVE SUMMARY:

This final report presents the results of our follow-up review of our May 1991 report entitled, "Need for the Food and Drug Administration to Review Improper Pre-Approval Promotional Activities" (A-15-91-00007). The May 1991 review looked at possible pre-approval promotion of bovine somatotropin (bST), a new animal drug developed to increase milk production in cows, which was still under review by the FDA's Center for Veterinary Medicine (CMV). Our current review found that CVM took appropriate corrective action in anticipation of recommendations made in our May 1991 report. In addition, CVM appropriately concluded that, overall, Monsanto-sponsored focus groups and a video produced beginning in December 1992 did not violate the intent of Federal regulations. However, we also found that CVM should have issued a warning letter stating that regulatory action would be taken should violative activities occurring at a January 1993 university seminar continue. The report makes recommendations to ensure that the Federal regulations governing pre-approval promotion is revised, in part, to address activities that sponsors can undertake while still being in compliance with this regulation. The PHS generally agreed with our recommendations.

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