Noteworthy FDA tightening rules on veterinary pre-marketing

WASHINGTON - The FDA is overhauling its regulations on pre-approval promotion activities for animal drugs in response to a Department of Health and Human Services Inspector General's finding that the agency was lax in overseeing pre-approval promotion of BST by Monsanto Co.

The conclusions by the Inspector General (IG) point more to a lack of coherence in government enforcement of regulations than to serious violations by Monsanto prior to the FDA's approval of bovine somatotropin, which is used to increase milk production by cows.