Former generic drug maker Kun Chae Bae has testified to a federal jury in Baltimore that he bought lunch and three vodka drinks for a high-ranking U.S. Food and Drug Administration official at the James III restaurant in Rockville on Dec. 11, 1987 to "get on his good side."
Thirteen days later, Bae said, his company received FDA approval to market a generic antibiotic that was a $1.5 million-a-year seller, after the approval papers had languished for months in the agency's Division of Generic Drugs.
Bae, a Korean immigrant who pleaded guilty in September to racketeering and illegal gratuities charges for bribing other government officials, testified for the prosecution over the past two days at the perjury trial of Dr. Marvin Seife, the now-retired former FDA division director, in U.S. District Court.
Seife, 66, is accused of lying under oath to U.S. Department of Health and Human Services investigators and a congressional committee about his acceptance of meals from representatives of the industry that his division regulated. He is the highest FDA official to be prosecuted, and the only one to stand trial, among five who have faced criminal charges here in a two-year probe of corruption in the FDA and the generic drug industry.
U.S. Attorney Breckinridge L. Willcox told the jury in an opening statement that the luncheon conversation between Bae and Seife "came very close to a bribe."
Willcox also said Seife had "surreptitiously" and routinely continued to accept lunches from industry representatives for years, even though he had been reprimanded for doing the same thing in 1980.
The issue at trial, Willcox said, is not whether Seife accepted the lunch from Bae but whether he lied about it later under oath.
"Dr. Seife had a good reputation, we do not dispute that," Willcox said. "But he felt he was above the law and was not governed by the restraints placed on other government employees."
"Why make a federal case out of it?" rejoined defense attorney Hamilton P. Fox 3rd, denigrating the prosecution's case. "It was no big deal."
Fox told the jury that Seife simply had forgotten about the lunch when he denied it under oath to the investigators and the House Subcommittee on Oversight and Investigations in July 1989, nearly two years later.
Fox also said Seife told investigators that "his practice was not to go to lunch with industry representatives," but freely admitted to them that he had violated that practice at least three different times.