Former FDA official gets fine, sentence in generic drug case

January 24, 1991|By Sheridan Lyons

The former director of the U.S. Food and Drug Administration's Division of Generic Drugs, convicted of lying about free lunches from companies seeking his agency's approval, received a 10-month sentence and a $25,000 fine yesterday, with a recommendation that he serve the time at a community facility and on home-release.

Marvin Seife, a 66-year-old physician now living in San Antonio, was found guilty by a U.S. District Court jury in October of two counts of perjury, becoming the highest-ranking defendant convicted in the 2 1/2 -year-old, continuing investigation of corruption in the FDA and the generic drug industry.

When he retired in December 1989, Seife had been director of the Division of Generic Drugs for 17 years. As director, he gave government approval for the marketing of generic drugs and supervised about 55 employees during the 1980s.

In 1980, he was temporarily suspended for accepting lunches from representatives of generic drug companies and was warned against doing so again, U.S. District Court Judge John R. Hargrove noted yesterday.

Two months before his retirement, according to the indictment, Seife lied under oath to an officer of the FDA's division of ethics and program integrity. He specifically denied having lunch on Dec. 11, 1987 -- and discussing FDA business -- with Milton Kaplan of the Warner Lambert Co. and with Kun Chae Bae at the James III restaurant in Rockville.

Bae, founder of My-K Laboratories in Chicago, pleaded guilty to racketeering and to making illegal gifts to Seife and to another government official in Philadelphia. He was placed on three months of work-release and ordered to pay a $25,000 fine.

Bae testified at Seife's trial that he bought lunch and three drinks for Seife to "get on his good side" and to complain about an FDA chemist who was delaying drugs he wanted to market.

Mr. Kaplan wrote a letter to the the congressional subcommittee on investigations and oversight in which he mentioned the lunch with Seife. However, according to the charges, Seife denied to the FDA investigator that he had ever met either man outside his office. Mr. Kaplan was not charged.

The second perjury conviction arose from Seife's statement under oath to the investigator that "Since 1980, I have made it a practice never to have meals with regulated industry."

So far, four lower-ranking FDA employees have pleaded guilty to receiving thousands of dollars in illegal gratuities from drug firms, and seven drug company officials, an industry consultant and three generic drug firms have pleaded guilty in the case.

In sworn testimony to the congressional subcommittee last nTC month, Maryland U.S. Attorney Breckinridge L. Willcox said the first phase of the investigation was almost completed but the effects of the corruption hadn't been determined.

Some companies have admitted switching drugs, he said, submitting as generics the actual brand-name drug repackaged in their capsules to get FDA approval, then marketing their own, untested drug. While no deaths were known to result, Mr. Willcox said, the safety of these untested drugs was unknown.

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