FDA Holding Up Generic Drug Applications from Pittsburgh Lab
WASHINGTON (AP) _ The Food and Drug Administration said today it is holding up applications for approval of generic drugs tested by a Pittsburgh lab whose work has been found by the agency to be flawed.
Pending applications based on the testing of Biodecision Laboratories Inc. were put on hold while the FDA continues its review of the results of an inspection of the lab, said FDA spokesman Jeff Nesbit.
The FDA’s inspection, in which 13 studies conducted by the lab on candidate generic drugs were reviewed, found that all but two violated FDA regulations or fell short of accepted laboratory practice.
The findings of the inspection, conducted last October through January, were released earlier this week. Biodecision is one of the nation’s largest independent testing labs.
The studies were to determine whether the candidate generic drug worked the same as the patented drug for which it would be sold as a substitute. A generic drug must be shown to be ″bioequivalent″ to a name-brand drug before it can win FDA approval.
Nesbit said seven of the 11 drugs in which Biodecision’s studies were flawed are not currently being sold. The remaining four are antibiotics, for which a broad potency range is acceptable.
Nesbit said he did not know how many generic drug applications were being held up.
Biodecision President Robert Lecher was quoted in The Pittsburgh Press as saying the laboratory has confirmed the findings of the 11 tests questioned by the FDA.
Lecher said the re-evaluations were part of the lab’s efforts to work with the FDA to correct problems found in the inspection. The lab has corrected all but one of the deficiencies cited in the inspection, he said.