FDA Asked to Review Drug Lab’s Accuracy

A powerful House member on Monday asked the Food and Drug Administration to freeze all approvals of generic drugs that rely on test results from a Pittsburgh laboratory until the agency reviews the accuracy of the lab’s procedures.

Rep. John D. Dingell (D-Mich.) said that scientific errors uncovered by an FDA audit of generic drug testing performed by Biodecision Laboratories may cast doubt on the reliability of hundreds of generic drugs.

Dingell disclosed that a recent FDA inspection of the laboratory’s testing work had looked at 13 studies the FDA relied on in approving drug-marketing applications and found that 11 of them “contained scientific errors sufficient to invalidate the results.”

Dingell is chairman of the House Energy and Commerce Committee and its oversight and investigations subcommittee, which has been investigating regulatory corruption and wrongdoing in the generic drug industry.

“Given the impact on the generic industry from corruption found to date, this latest revelation of impropriety is truly calamitous,” Dingell said in a letter to Health Secretary Louis W. Sullivan.

Robert Lecher, president of Biodecision, said his company was cooperating with the FDA in an effort to verify the firm’s laboratory results and expected few problems to surface.