FORMER FDA GENERIC DRUGS DIVISION DIRECTOR MARVIN SEIFE INDICTED
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.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth
Sign in to continue reading.
Need a specific report?
1000+ reports available
New to Pink Sheet?
Start a free trial today!
Register for our free email digests: