Grand Jury Indicts Former Halsey Drug Executives in Drug Probe
BALTIMORE (AP) _ A federal grand jury has indicted five former executives of a generic drug company for allegedly manufacturing adulterated and unapproved drugs and lying to the U.S. Food and Drug Administration.
The jury returned a six-count indictment Monday charging Jay Marcus, the former president of Halsey Drug Co., Inc. of Brooklyn, N.Y., with conspiring to obstruct FDA regulators.
Other former Halsey executives charged were Hedviga Herman, vice president of manufacturing; Fredrick Shainfeld, senior vice president of technical and regulatory affairs; Amirul Islam, vice president of technical services, and Muhammad Uddin, former assistant vice president of research and development.
The defendants are also charged with shipping adulterated and unapproved new drugs, making false statements to the FDA and obstructing an investigation. They face at least 10 years imprisonment and $500,000 in fines if convicted.
Gary Jordan, U.S. attorney for Maryland, said the defendants changed ingredients and manufacturing processes for generic drug products without FDA approval. These alternative formulas were kept on ″phony cards″ that were hidden from FDA inspectors, he said.
Among the illegally manufactured drugs were quinidine gluconate, used to treat irregular heartbeats; propylthiouracil, used to treat hyperthyroidism; metronidazole, an anti-bacterial medication, and acetaminophen and codeine phosphate, a prescription narcotic painkiller.
Prosecutors allege that when Halsey products failed quality control testing, the company would retest them until they passed or rework the batches without obtaining required FDA approval.
Reworked batches included quinine sulfate capsules, used in the treatment of malaria, and hydralazine hydrochloride, a blood pressure medication.
On July 8, Jordan filed a motion charging Halsey with five felony counts. Halsey’s new management announced it reached a plea agreement with the U.S. Attorney’s office and is cooperating in the investigation.
The indictments are the latest in a 4 1/2 -year probe into the generic drug industry led by the U.S. Attorney’s office in Maryland.