Two former officials of generic drug companies have pleaded guilty in federal court to criminal charges for falsifying records to hide deficiencies in products approved for sales to the public in the late 1980s.
Juan Manuel Rodriguez, 61, former product development manager at Bolar Pharmaceutical Co., pleaded guilty in U.S. District Court here last Thursday to a charge of attempting to obstruct a U.S. Food and Drug Administration investigation of RTC the Copiague, N.Y., company regarding its then-popular Triamterene-Hydrochlorothiazide, a generic hypertension medicine.
A day earlier, John W. Bushlow, 44, former president for operations at Vitarine Pharmaceuticals, pleaded guilty in federal court to a false statements charge for directing employees at the company's plant in St. Croix, Virgin Islands, to create phony records to conceal an unapproved process that Vitarine used to make capsules of Cephradine, an antibiotic.
Prosecutor Gary P. Jordan said Rodriguez, who quit Bolar in 1988, doctored a research notebook at the request of a "senior Bolar official" to make his data mesh with false testing data that the company had given the FDA to hide its product-switching in the testing process.
Jordan told Judge John R. Hargrove that the senior official asked Rodriguez to rewrite the notebook in 1989 in an attempt to mislead FDA investigators.
When Rodriguez agreed, the official gave him a battered notebook and several pens containing different-colored inks that the defendant used to make his research data consistent with the company's other false documentation, and to make it look as if it had been written over some time.
Jordan said Rodriguez also made a copy of his accurate, original notebook, and gave it to federal investigators recently when he began to cooperate with them in a plea bargain.
Justice Department prosecutor Lawrence G. McDade, told Hargrove on Wednesday that Bushlow ordered employees at Vitarine's St. Croix plant to make several lots of Cephradine using a process that was unapproved by the FDA.
Bushlow had told his superiors at Vitarine that the company could not manufacture Cephradine by the FDA-required process but was directed by them to make it anyway to meet the company's sales commitments.
Bushlow later falsified production records to make it appear to FDA investigators that the proper process was used.
Rodriguez is the fourth former Bolar official to plead guilty to criminal charges tied to product-switching. The company also pleaded guilty to corruption charges in the summer and agreed to pay a $10 million fine.
Bushlow, who also is cooperating with the government in the probe, is the second Vitarine official convicted of federal charges.