In last Thursday's editions, the disposition of a U.S. District Court case involving PharmaKinetics Laboratories of Baltimore was incorrectly reported.
PharmaKinetics itself was fined $200,000 in June after pleading guilty to obstructing an agency proceeding -- a Food and Drug Administration investigation involving generic drug testing and certification.
The company's former executive vice president, Mark B. Perkal, is awaiting sentencing for his guilty plea to obstruction and aiding and abetting charges.
FOR THE RECORD - CORRECTION
+ The Sun regrets the errors.
Federal prosecutors are seeking a $1 million fine and a prison term for a former generic-drug company official who has pleaded guilty to federal charges of fraud and obstruction of justice.
Jacob H. "Jack" Rivers, former vice president of the Bolar Pharmaceutical Co., pleaded guilty yesterday in U.S. District Court in Baltimore to two counts of filing a false statement with the U.S. Food and Drug Administration and one count of obstruction of justice.
Gary P. Jordan, first assistant U.S. attorney, said he will recommend that Judge John R. Hargrove impose the fine and a four-year prison term for Rivers, 63, of New York, who also was a member of Bolar's board of directors. The company, based in Copiague, N.Y., was fined $10 million last year for fraud.
A court document said Rivers and other Bolar officers engaged in a series of fraudulent activities beginning in 1982. Rivers and other officials prepared their drug applications before the company had a working formula or finished sample because they wanted to get their product on the market before their competitors, prosecutors said.
Rivers disguised brand-name drugs as Bolar products and submitted them to an independent research laboratory for testing.
The human tests are supposed to determine whether a drug goes through the bloodstream and dissolves at the same rate as the brand-name drug it imitates. But the Bolar tests were rigged to match the brand-name product against itself, prosecutors said.
The disguised drugs were Thioridazine Hydrochloride, used for treatment of depression and psychotic disorders; Oxytriphylline Enteric, for bronchial problems; Nitrofurantoin Macrocrystalline, for urinary tract infections; Meclofenamate Sodium, for treatment arthritis; and Triamterene/Hydrochlorothiazide.
Triamterene/Hydrochlorothiazide, a generic brand of the anti-hypertensive drug Dyazide, was approved in April 1987 by the FDA and generated $140 million in revenue for Bolar before it was recalled in February 1990.
Prosecutors said Rivers and other Bolar officials obstructed an FDA investigation into the fraud by creating false documents, destroying records and drug samples, lying to the FDA and causing other employees to lie to the agency.
PharmaKinetics Laboratories in Baltimore, which conducted tests for Bolar, and its top official have pleaded guilty to obstruction and aiding and abetting charges in connection with the Bolar case. The company has been fined $200,000.