BALTIMORE, OCT. 23 -- A former top official of the Food and Drug Administration went on trial today on perjury charges in the ongoing federal corruption probe of the FDA and the generic drug industry it regulates.
Marvin Seife, 66, head of the FDA's generic drug division until his retirement in December 1989, is charged with lying to investigators about meals he allegedly had with drug company executives seeking approval of new products. If convicted, he faces up to 10 years in prison and $500,000 in fines.
Seife is the highest-ranking government official charged so far in the two-year-long investigation and the first to stand trial. Four of Seife's subordinates have pleaded guilty to receiving thousands of dollars in illegal gratuities from drug firm executives and have been sentenced to prison. Nine generic drug companies, officers and consultants also have pleaded guilty.
Generic drugs are discount versions of brand-name products whose patents have expired, making them available for copying. Investigators say this creates an atmosphere in which fraud and corruption can flourish as generic drug companies compete to get their products approved by the FDA and marketed.
Attorneys for Seife contended in opening statements to a federal court jury here that the perjury charges involve statements Seife made that were either true on their face or false only because of Seife's faulty memory.
But Breckinridge L. Willcox, the U.S. attorney for Maryland, said Seife lied to hide his dealings with drug executives over the years, in particular a scheme in which one executive agreed to bankroll a $150,000 to $200,000 lobbying effort in Congress to expand Seife's office and authority.
In the two-count indictment, Seife is charged with lying in an Oct. 25, 1989, affidavit when he denied having had lunch with two drug company executives on Dec. 11, 1987. He also is charged with lying when he said, "I have made it a practice never to have meals with regulated industry."
Kun Chae Bae, 56, former president of My-K Laboratories in suburban Chicago, testified that he and Warner Lambert drug company representative Milton Kaplan met with Seife for lunch at the James III restaurant in Rockville in December 1987.
Bae said he paid for the $59.20 meal with his American Express card. During the meal, he said, Kaplan described his plan for enlarging Seife's role at the FDA and Bae offered $150,000 to $200,000 to pay the Washington lobbying firm of Parry & Romani to push the necessary legislation through Congress. He said the plan died shortly thereafter.
Bae said that at the same meeting he told Seife that one of the chemists in his division had been delaying approval of an antibiotic drug called Sulmaprim that Bae's company was pushing. Thirteen days later, Bae said, the drug was approved.
Bae has pleaded guilty to racketeering charges in connection with paying $10,000 to a Seife subordinate and is awaiting sentencing.
As further evidence that Seife wanted to conceal the December 1987 meeting from investigators, Willcox told the jury that the desk calendar seized from Seife by investigators shows the penciled notation "Kaplan -- Lunch" for Dec. 11, 1987. The word "Lunch" has been erased, Willcox said, "but if you hold the paper to the light, you can still see the pencil impression" of the word.
Willcox said Seife regularly dined with generic drug executives and others will testify about those meetings this week.
Defense attorney Hamilton P. Fox said Seife denied dining with Bae and Kaplan because his memory faded between the December 1987 meal and his signing of the affidavit for investigators on Oct. 25, 1989.
Also, Fox argued, while Seife said he "made it a practice" not to have meals with drug executives, his affidavit cited two exceptions. He said FDA regulations permit occasional social meals with industry executives, as long as FDA employees pay their own way and do not discuss specific regulatory business.