Report Questions Data on Drugs for Animals

The Food and Drug Administration may be approving drugs for food-producing animals on the basis of “invalid, inaccurate or fraudulent data” from private laboratories, a new government report says.

The FDA did not conduct inspections to verify the accuracy of the data supplied to support more than half the animal drugs it approved, the General Accounting Office said in the report, which covers October, 1985, through September, 1990.

The GAO said that the drugs “may be supported by data of unknown validity.”

It said the FDA’s “inadequate procedures” may mean that it “may be unable to fulfill its mission to protect the health and safety of animals and people.”

FDA officials “generally disagreed with our conclusion that FDA is unable to adequately ensure the integrity of sponsor-submitted data,” the GAO said.

But the agency said FDA officials agree with recommendations for tightening the review process, improving the training of data reviewers, developing a system of tracking all inspections and focusing inspections on the most critical cases.

Rep. Ted Weiss (D-N.Y.), chairman of a House Government Operations subcommittee on human resources, said he requested the study because the FDA has accused a major drug manufacturer of manipulating data to support approval of an animal drug.

“The GAO findings are profoundly disturbing, because FDA appears virtually incapable of preventing animal drug data fraud,” Weiss said. “FDA was unaware that one particular company had for years submitted false data.”