FDA, Drug Company Official Charged In Bribery Scam
BALTIMORE (AP) _ Prosecutors say charges against a Food and Drug Administration chemist and a drug company executive are the first in a probe of government and industry officials in a generic drug-approval scam.
″Our investigation has revealed serious flaws in the FDA approval process for generic drugs, and we will be vigorously pursuing all evidence of corruption on the part of drug manufacturers and public officials alike,″ Breckenridge Willcox, U.S. attorney for Maryland, said Thursday.
David Brancato, a review chemist with the FDA’s Division of Generic Drugs, was charged with receiving three bribes totaling $4,300 from officers of two generic drug manufacturers.
Raj Matkari, vice president of Pharmaceutical Basics Inc., was charged with giving a $2,000 bribe to Charles Chang, branch chief of the FDA’s Division of Generic Drugs, Willcox said. Matkari has agreed to plead guilty, said his attorney, Phil Fox.
Brancato and Chang were bribed for official acts they had performed or were to perform, court documents filed by Willcox said.
Chang and the two companies were not charged Thursday and the U.S. attorney’s office did not reveal whether it planned to press charges against them.
Willcox said his investigation is expected to generate additional criminal charges in coming weeks, but FDA officials have said in statements that any alleged wrongdoing is not widespread.
The charges were filed Thursday in U.S. District Court in Baltimore. Brancato, 38, of Rockville, Md., faces a maximum of six years in prison and a $750,000 fine. Matkari, of Berthoud, Colo., faces a maximum of two years in prison and a $250,000 fine, Willcox said. Both are cooperating with the government, he said.
Broncato’s attorney, Philip H. Armstrong, declined to comment.
The FDA’s Division of Generic Drugs is responsible for the review and approval of applications submitted by pharmaceutical manufacturers seeking to market drugs similar in formula to brand-name drugs.