GAO probe finds FDA’s criminal investigative offices go years without review

GAO cites lax oversight of FDA investigative unit

WASHINGTON — The Food and Drug Administration has not reviewed the majority of its criminal investigation offices in more than three years, even though its own rules call for regular evaluations.

A Government Accountability Office report due out Thursday finds little oversight of FDA’s unit for investigating counterfeit drugs, contaminated food and other criminal activities. The report was obtained Wednesday by The Associated Press.

Established in 1991, FDA’s Office of Criminal Investigations has grown into a 230-person operation with more than $41 million in funding. In 2008, the group’s investigations led to more than 400 convictions.

However, the GAO report describes an operation that has never been subject to regular, methodical evaluation by FDA leadership.

“The FDA regulates about 25 percent of the economy, including the drug and device industry, and it’s not in a position to investigate wrongdoing with much effectiveness without an investigative force that’s up to the job,” said Sen. Charles Grassley, R-Iowa, who requested the report.

Since her confirmation last May, FDA Commissioner Margaret Hamburg has vowed to step up regulatory actions against companies that don’t follow food and drug safety laws.

In a letter to Grassley released Wednesday, Hamburg said the FDA has already made progress on many of the issues cited in the GAO’s report. For instance, the agency has drafted guidelines for information-sharing between criminal investigators and other parts of the FDA. The agency also plans to bolster its program for disqualifying researchers involved in unethical medical testing.

FDA’s criminal investigators operate out of six offices across the U.S., and each office is supposed to undergo evaluation at least every three years.

However, the GAO found that only seven evaluations, or roughly 30 percent of those required, took place between 1996 and last August. One office has not been reviewed in more than a decade, according to GAO investigators.

In addition, the report states that FDA has not developed any concrete measures for grading the criminal investigation office, beyond its broad mission to “conduct and coordinate investigations of suspected criminal violations.”

According to the GAO, FDA’s criminal investigations office “appears to operate more autonomously than other units.”

While the director of criminal investigations meets with a deputy commissioner each week, he is not required to report any specific information, and there are no notes to document the meetings.

“The lack of a requirement for OCI to report regularly on specific topics to FDA senior-level officials means that FDA has relied largely on the OCI director to determine which aspects of OCI’s operations and investigations are made known to FDA’s top management,” states the GAO report.

FDA’s Office of Criminal Investigations is directed by Terry Vermillion, who spent more than 20 years with the Secret Service before taking the job.

In a written response, the FDA said it agreed with GAO’s recommendations to improve oversight of the criminal division. The agency plans to allocate more funding to conduct field office evaluations and is developing criterion to track performance on a monthly basis.

The FDA hopes to roll out the new measures this spring.