FDA Chemist, Drug Manufacturers Charged in Bribery Probe
BALTIMORE (AP) _ A federal Food and Drug Administration chemist and two generic drug company executies were charged Monday with bribery in an investigation into corruption in the FDA, a federal prosecutor said.
Walter Kletch, an FDA chemist in the Division of Generic Drugs in Rockville, Md., is accused of receiving two $500 gift certificates from Dilip Shah, president of Quad Pharmaceuticals of Indianapolis, said U.S. Attorney Breckinridge L. Willcox.
The generic drugs division reviews applications submitted by pharmaceutical companies seeking to market such drugs. FDA chemists must ensure that the drugs are safe and effective and are equivalent to their brand-name counterparts.
Kletch was responsible for reviewing Quad’s applications.
Shah and Ashok Patel, a former executive of Par Pharmaceuticals of Spring Valley, N.Y., have been accused of bribing Charles Chang, an FDA branch chief. Both Par and Quad had applications reviewed by chemists supervised by Change, the charges say.
The charges were in a criminal information, a document equivalent to a indictment but not requiring a grand jury.
If convicted, Kletch, Shah and Patel would each face a maximum penalty of two years in prison and a $250,000 fine.
Chang has pleaded guilty to two counts of interstate travel in aid of racketeering for accepting furniture and a trip around the world from another generic drug manufacturer. He is awaiting sentencing.
Previously charged in the probe were Raj Matkari, a drug company executive who pleaded guilty to bribing Chang, and David Brancato, a review chemist in Chang’s branch who pleaded guilty to receiving cash gratuities from Shah and Patel.
Matkari and Brancato also are awaiting sentencing.