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FORMER FDA GENERIC DRUGS DIVISION DIRECTOR MARVIN SEIFE INDICTED

Executive Summary

FORMER FDA GENERIC DRUGS DIVISION DIRECTOR MARVIN SEIFE INDICTED on two counts of perjury in Baltimore federal court on June 19 "for lying to government investigators concerning his receipt of meals from representatives of the generic drug companies that he regulated," according to a same-day press release from the Maryland U.S. Attorney's office. The director of FDA's Division of Generic Drugs from 1972-89, Seife, 66, currently resides in San Antonio. He is the fifth former FDAer indicted in connection with the generic drug scandal. According to the indictment, Seife gave a sworn statement to an FDA investigator on Oct. 25, 1989 in which he denied meeting with two generic drug company execs on Dec. 11, 1987 to discuss FDA matters. The indictment alleges that he had lunch with Milton Kaplan, an employee of Warner-Lambert at the time, and K.C. Bae, the founder of My-K Labs. Bae was charged in April with making a$10,000 payment to Chang. Seife made a similar denial in testimony before Rep. Dingell's (D-Mich.) House Energy and Commerce/Oversight subcommittee on July 11, 1989, and, the U.S. attorney's release says: "It is alleged that Dr. Seife's denial of that meeting was false." David Nelson, key aide to Rep. Dingell, has praised Seife in the past for his role in helping to unravel the generic scandal ("The Pink Sheet" March 19, p. 3). The indictment further charges that Seife lied to the same FDA investigator when he told him that he "made it a practice never to have meals with regulated industry." Seife's declarations "were false in that on numerous occasions in 1986, 1987, and 1988 [he] accepted and received numerous lunches, dinners and drinks paid for by representatives" of drug companies, the indictment alleges. If convicted on both counts, Seife faces a maximum punishment of 10 years in jail and a fine of $500,000.

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