GAO asked to investigate FDA disciplinary delays

WASHINGTON The ranking Republican members of the House Energy and Commerce Committee and the Oversight and Investigations Subcommittee have written a letter to the Government Accountability Office stating that the office should investigate delays by the Food and Drug Administration in disciplining researchers who break rules while testing drugs in people.

The representatives, Joe Barton of Texas, who is the top member of the Energy and Commerce Committee, and John Shimkus of Illinois, the top Republican for the Oversight and Investigations Subcommittee, cited a report from Bloomberg in its letter addressed to the GAO. That report said the FDA failed to complete disciplinary action against 12 researchers after proposing that they be disqualified from trials based on findings that they violated agency rules to protect patients and ensure accurate data.

“The FDA has waited months and sometimes years to take action against doctors who lied about their work on critical clinical studies of new drugs and who put their own patients at risk,” Barton said in a statement. “There's just no excuse for not invoking the authority the FDA already has to rapidly disqualify liars from taking any further role in these drug studies.”

In addition to investigating delays, the lawmakers' letter asked the GAO to examine whether the FDA's oversight is “effective in identifying clinical investigators whose practices or conduct may compromise the quality and integrity of clinical data or the safety of participants in clinical trials.”