Pittsburgh Lab Criticized by FDA Inspectors
WASHINGTON (AP) _ Eleven out of 13 studies conducted for generic drug manufacturers by a Pittsburgh lab violated regulations of the Food and Drug Administration or standards of good laboratory practice, according to an FDA inspection, an agency spokesman said Monday.
The lab, Biodecision Laboratories, promised to correct the flaws. FDA headquarters is analyzing the inspection reports to see if they affect any drugs recently approved or waiting for approval, said the spokesman, Don McLearn.
″We will take appropriate action,″ McLearn said.
He said he did not know what drugs were involved. ″This is not a product issue, but how a lab conducts its business,″ he said.
Biodecision is one of the more heavily used laboratories in the generic drug industry, McLearn said.
The studies were so-called ″bioequivalence″ studies aimed at showing that a candidate generic drug reaches the same concentration in the bloodstream as the patented drug for which it will be sold as a substitute.
McLearn said an example of violation of standards of good practice would be starting an analysis before validation of the method being used.
The agency can refuse to accept data from labs it deems unreliable, but McLearn said the company ″is not in that kind of jeopardy at this point.″
The inspection was conducted in January and the company reported its plans for corrective action in March. At some point, FDA probably will approve or disapprove those plans, McLearn said.
The agency has been wrestling with problems in the generic drug industry for more than a year, with some drug manufacturers having been found to have cheated on their lab tests and bribed FDA officials.
In Pittsburgh, a man answering the company’s telephone who identified himself as a guard said no one was available to comment. In Tuesday editions, The Washington Post quoted the company president, Robert Lecher, as saying, ″We view the entire process as very constructive and have taken it extremely seriously. We don’t take issue or disagree with any of the observations.″