Bolar Pharmaceutical Co.'s former regulatory affairs manager has pleaded guilty to federal criminal charges for rigging tests of a lucrative generic hypertension drug so the U.S. Food and Drug Administration would approve it for public sale.
The defendant, Gloria H. Schetlick, pleaded guilty in U.S. District Court in Baltimore yesterday to false statement and obstruction of justice charges.
Prosecutors alleged that Schetlick mislabeled Bolar drug samples so they would pass FDA-required "bioequivalency" tests, submitted the bogus test results to the FDA for approvals and lied to agency officials in a later attempt to hide the test rigging.
Schetlick, 35, of North Plainfield, N.J., is the second former Bolar official to be convicted of obstruction of justice for acts tied to the company's efforts to produce and sell Triamterene Hydrochlorizide, a Dyazide substitute. Bolar sold $140 million worth of the capsules between August 1987 and January 1990, when the FDA halted its production.
Breckinridge L. Willcox, the U.S. attorney for Maryland, said Schetlick is cooperating with the government in a "continuing investigation of misconduct at Bolar" by prosecutors in Willcox's office and the Justice Department's Office of Consumer Litigation.
Robert Shulman, Bolar's former president, and Jack Rivers, former executive vice president, are known targets of the investigation. They left Bolar last year after the company came under congressional scrutiny for alleged product-switching.
Bolar has said publicly that all of its employees who were involved in the alleged misconduct no longer work there.
Prosecutors Gary P. Jordan and Lawrence G. McDade told Judge John R. Hargrove yesterday that Schetlick mislabeled Triamterene used in the bioequivalency tests so that samples of already-approved products were tested against themselves. She did so at the direction of "a senior Bolar official," the prosecutors said.
The product switching occurred in early 1988, after one batch of Bolar's Triamterene drug failed the bioequivalency tests for safety and effectiveness.
Predictably, the mislabeled Triamterene passed the second round of tests and Bolar submitted the rigged test results for FDA approval, prosecutors said.
Schetlick also lied to FDA officials about the product switching at a meeting in September 1989 after the agency began proceedings to cancel its approval of Triamterene.