Federal prosecutors in Baltimore today filed criminal charges against four more pharmaceutical company officials in the continuing probe of fraud and misconduct in the generic industry.
In addition, Steven Colton, former vice president and director of research and development at Vitarine Pharmaceuticals Inc., was sentenced for making false statements to hide product-switching in generic drug tests required by the U.S. Food and Drug Administration.
Colton was given 27 months in federal prison and two years of supervised release afterward. Gary P. Jordan, first assistant U.S. attorney here, said Colton's offenses "strike at the very heart of the generic drug problem" because product-switching "means that these drugs aren't being tested at all before they're sold."
New criminal information documents filed today in U.S. District Court in Baltimore charged:
* John W. Bushlow, Vitarine's former vice president for operations, with directing employees at a plant in the Virgin Islands to create false records to conceal an unapproved process that Vitarine used to make Cephradine capsules.
* John E. Botzolakis, a former Parke-Davis Co. research scientist, with conspiracy to transport stolen property. Botzolakis sold trade secrets, including formulas and other information on the drugs Prazepam and Erythromycin, to an official of American Therapeutics Inc. for $14,000, prosecutors said.
* Sanyasi R. Kalidindi, a former vice president of American
Therapeutics, with filing a false application that misrepresented ATI's development and manufacturing processes for Erythromycin in an attempt to get FDA approval of the drug for public sales.
* Juan Manuel Rodriguez, former product development manager Bolar Pharmaceutical Co., with falsifying data in an alleged attempt to obstruct an FDA investigation of Bolar.
Bolar and three of its former officials already have pleaded guilty to criminal charges for a wide range of offenses tied to product-switching in FDA-required generic drug tests.
The new charges were filed by Jordan and Lawrence G. McDade, of the Justice Department's Office of Consumer Litigation in Washington.
The filing of criminal informations usually means the defendants have waived indictment and have agreed to plead guilty to the charges.
Prosecutors said Bushlow, Kalidindi and Rodriguez are cooperating with the government in the investigation.