The former director of the U.S. Food and Drug Administration's generic drug division has been convicted of two perjury charges for lying to federal investigators about accepting lunches from officials of the industry his agency regulated.
Dr. Marvin Seife, 66, of Houston, the division director for 18 years until he retired last December, is the highest-ranking FDA official to be convicted in a two-year investigation that has resulted in the convictions of more than a dozen former FDA officials, generic drug companies and company executives on corruption charges.
The jury, which heard a week of testimony, deliberated about 3 1/2 hours in U.S. District Court in Baltimore before returning its verdict.
Seife faces maximum penalties of 10 years in prison without parole and $500,000 in fines when he is sentenced Jan. 23.
The charges stemmed from an Oct. 25, 1989, affidavit that Seife signed for FDA investigators in which he denied accepting a free lunch on Dec. 11, 1987, at the James III Restaurant in Rockville.
Seife dined that day with Milton Kaplan, a Parke-Davis official, and K.C. Bae, former owner of My-K Laboratories, an Illinois generic drug maker, at a time when Seife's division was considering approvals of My-K products.
"I have never met anywhere with Mr. Kaplan and/or Mr. Bae, nor have I discussed any FDA matters with these gentlemen other than at my government office," Seife said in the sworn, hand-written affidavit he gave to FDA investigator James Ritz.
Seife also said in the affidavit that he "made it a practice never to have meals with regulated industry."
Prosecutors Breckinridge L. Willcox and Geoffrey R. Garinther contended Seife not only lied twice in that document, but also lied about the Kaplan-Bae lunch to a congressional subcommittee at hearings in July 1989.
"Dr. Seife set the tone for and presided over an unprecedented level of mismanagement and corruption that almost brought down the generic drug industry," Garinther told the jury in closing arguments yesterday.
"If he had admitted the lunch . . . it would have destroyed his career and his professional reputation."
Prosecutors built their case against Seife from credit card receipts and testimony from industry officials -- several of whom have been convicted of bribing FDA employees to gain favored treatment for their products.
Bae, who is awaiting sentencing on conviction of racketeering and of providing illegal gratuities, testified that he paid for the James III Restaurant lunch.