Bolar Pharmaceutical Co.'s former research and development director has been charged with obstructing a U.S. Food and Drug Administration investigation, U.S. prosecutors said in Baltimore today.
Gena R. Finelli, the former Bolar official, was charged in a criminal information document with telling research chemists to lie to FDA investigators during a routine compliance inspection of Bolar's Copiague, N.Y., plant Sept. 21, 1989.
Finelli allegedly told the chemists to deny that they kept test results on generic drugs Bolar intended to market after obtaining FDA approval, said U.S. Attorney Breckinridge L. Willcox, and First Assistant U.S. Attorney Gary P. Jordan.
Willcox said Finelli told the chemists to lie to FDA investigators on orders from another company official who was not named in the information document. The prosecutors declined to identify him.
The prosecutors said Finelli has agreed to cooperate with the government investigation, which is expected to yield more criminal charges later this year.
Bolar is one of the nation's top-ranking generic drug firms. For more than a year, it has been a target of investigations by the U.S. Justice Department, the FDA, the Department of Health and Human Services and Congress.
Finelli is scheduled for arraignment in federal court Oct. 25. She faces maximum penalties of five years in U.S. prison without parole and a $250,000 fine on conviction.
In the past two years, six drug company officials, three generic drug manufacturing firms and four former FDA officials have pleaded to bribery and related charges in federal court in Baltimore.