Four officials of Bolar Pharmaceuticals Inc., once the nation's largest generic drug maker, have been indicted on charges of lying to federal regulators about applications for generic drugs.
The drugs included heart and high-blood pressure medication, but investigators have no evidence anyone was harmed by taking them, the U.S. attorney's office said.Bolar Pharmaceuticals was fined $10 million in March for selling adulterated and mislabeled generic drugs, the largest criminal fine ever imposed by the Food and Drug Administration.
The charges are the latest in a federal task force's three-year investigation of the generic drug industry. Generic drugs are lower-priced equivalents of brand-name drugs.
"It was the essence of this conspiracy that in order to maximize Bolar's profits, its members attempted to evade, defeat and obstruct FDA's regulatory authority over the approval, manufacture and distribution of generic drug products," the indictment issued Thursday said.
Robert Schulman, 58, was charged with conspiracy, making false statements to the FDA, wire fraud and obstructing an FDA investigation.
Schulman, from Centerport, N.Y., was Bolar's president, chief executive officer and chairman of the board. If convicted, he faces up to five years in jail and fines of $250,000 for each count.
Schulman is cooperating with investigators, Assistant U.S. Attorney Gary Jordan said.
Jacob Rivers, 62, of Great Neck, N.Y., former executive vice president of Bolar, was charged with conspiracy, making false statements to the FDA and obstructing an FDA investigation.
Charles Dicola, 41, of Hauppauge, N.Y., former vice president of operations, was charged with conspiracy and shipping adulterated generic drug products.
Arnold Mendell, 47, of Lake Grove, N.Y., former director of quality assurance, was charged with conspiracy, shipping adulterated generic drug products and obstructing an FDA investigation.
Rivers, Dicola and Mendell face maximum penalties of three to five years in jail and fines of $250,000 for each count.
"We intend to contest each and every one of the charges," said Reid Weingarten, an attorney for Rivers.