A former high-level employee of the Bolar Pharmaceutical Co. Inc. has been charged with obstructing the U.S. Food and Drug Administration's investigation of the company, federal prosecutors said yesterday.
Gena R. Finelli, who is to be arraigned in U.S. District Court in Baltimore on Oct. 23, was director of Bolar's research and development laboratory. She was named in a one-count criminal charge and has agreed to cooperate with the government's investigation.
According to Gary P. Jordan, first assistant U.S. attorney, FDA officials in Rockville asked their counterparts in New York last year to inspect Bolar for possible violations of the Food and Drug Act. While inspecting the company, which is based in Long Island, N.Y., FDA officials allegedly asked to talk to laboratory chemists who worked for Ms. Finelli.
The criminal charge filed against her alleges that on Sept. 21, 1989, Ms. Finelli, at the direction of an unnamed officer at Bolar, told the chemists under her supervision to lie to FDA investigators about the existence of notebooks in which the chemists recorded results of tests.
The. Finelli case is the second in an expected new wave of indictments arising from allegations that companies gave false data in order to win approval of their products.