Former senior officials of Bolar Pharmaceutical Co. ordered product substitutions, coverups and other criminal misconduct so the company could derail federal investigations and continue to sell a highly successful generic hypertension drug to the public, according to federal prosecutors.
Sales of the drug, a Dyazide generic substitute called Triamterene/Hydrochlorothiazide, brought Bolar $142 million in revenues in 2-1/2 years, between August 1987 and January 1990, before it was removed from the market at the request of the U.S. Food and Drug Administration.
Assistant U.S. Attorney General Stuart M. Gerson and Breckinridge L. Willcox, the U.S. attorney for Maryland, said last night that the Bolar drug was untested, but they did not know the effects it may have had on consumers.
First Assistant U.S. Attorney Gary P. Jordan, a federal prosecutor here, and Lawrence McDade, of the Justice Department's consumer litigation office, detailed the litany of alleged Bolar misconduct at a related hearing in U.S. District Court in Baltimore yesterday.
Jordan said that when Bolar's generic hypertension drug came under scrutiny in FDA-required bioequivalency tests, a "senior official" of the company ordered numerous falsifications of records involving lot numbers of ingredients and batch numbers of drugs, substitutions of name-brand drugs in Bolar capsules so the drugs could pass the tests, and alterations of computerized data.
The bioequivalency tests are required by the FDA for all generic "copycat" drugs to ensure that they meet safety and effectiveness standards.
The Bolar official, Jordan said, also ordered Gena R. Finelli, the company's research director, and several research chemists to backdate records and to lie to FDA inspectors who came to Bolar's Copiague, N.Y. plant in 1988 after the testing came under suspicion.
Finelli, 47, of Huntington, N.Y., pleaded guilty here yesterday to one count of obstruction of an FDA investigation for her participation in the coverup.
Jordan declined to name the Bolar official who allegedly ordered much of the misconduct. But he said Ginelli is fully cooperating in a continuing federal investigation of Bolar employees and he expects more criminal charges to be filed.
Bolar also is a defendant in a multimillion-dollar fraud case in U.S. Court in Philadelphia in connection with its alleged antics with the generic hypertension drug.