PharmaKinetics Laboratories Inc., a Baltimore-based generic-drug development company, said yesterday that it has been warned by the Food and Drug Administration that it is in violation of guidelines governing drug testing.
The FDA said in a Dec. 28 letter to the company that PharmaKinetics had failed to follow established rules for drug tests involving people. Specifically, the federal agency criticized the company for failing to document the medical reasons for including in tests in 1990 and 1991 people who did not meet the company's own criteria for such volunteers. The FDA also faulted the company for failing to inform its internal Institutional Review Board of changes in the rules that would allow those volunteers.
The review board is a panel of experts that oversees and approves guidelines, conditions or protocols for drug studies.
The FDA letter warns that failure to take corrective action would result in regulatory sanctions. The company said it had already taken steps to correct shortcomings.
PharmaKinetics pays people to test generic drugs it develops for large U.S. and Canadian drug companies. In addition, it uses test volunteers, and it employs 160 people in Baltimore.
V. Brewster Jones, PharmaKinetics' president and chief executive officer, described the warning letter as routine. But he also said yesterday that it came as a surprise because the company has been talking with the FDA and has already taken corrective action.
"They are saying, 'If you have already made the corrections, prove it to us by current examples,' " Mr. Jones said.
"We were in the process of that anyway, and we will now reply in writing and be more determined and more specific about our meeting [the] requirements," he said.
Mr. Jones said the warning letter should not affect current tests and contracts, and he expressed confidence that the company would meet FDA standards.
The warning comes as the company is getting back on its feet after financial troubles linked to a federal investigation of the generic-drug industry.
PharmaKinetics emerged from bankruptcy last spring, three years after being implicated in a generic-drug-industry scandal and losing nearly half its customers as a result. Its former chief executive pleaded guilty to failing to tell the FDA that one large customer, Bolar Pharmaceutical Co. Inc., had submitted false data on drug tests.
The company has been profitable in all but one quarter in the past two years, however, and expects to report revenue in 1993 of $11 million -- about double its revenue in 1991.