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Executive Summary

FORMER FDA GENERIC DRUGS DIVISION DIRECTOR SEIFE IS ON PAROLE after a March 30 order from Baltimore Federal Court Judge John Hargrove. Seife's 10-month sentence was commuted to time already served, and he began the two-year term of his probation sentence immediately upon issue of the court order. The sentence was commuted due to the serious infection contracted by Seife in prison and the subsequent amputation of his left leg below the knee ("The Pink Sheet" March 16, T&G-1). Before Seife entered prison, his attorney Hamilton Fox (D.C. law firm Sutherland, Asbill & Brennan) filed a medical report notifying the Federal Bureau of Prisons that as a result of bilateral hip replacements due to asceptic necrosis, the former FDAer was susceptible to recurrent infections that would require the immediate attention of a physician. That information apparently was not relayed to prison officials due to the loss of Seife's paperwork. Because of the paperwork confusion, Seife spent his first 12 days in prison in solitary confinement, where he developed blisters which became infected. Spread of the infection eventually led to gangrene and amputation of the limb. Following the operation, Seife sustained renal failure, septic shock, pneumonia and lapsed briefly into a coma. He was transferred to Nix Medical Center in San Antonio on March 6, where he remained in intensive care until March 27. While Seife has been moved from intensive care to a private room, he faces additional operations on his right leg, which also has become infected. During the week of March 30, doctors operated on the right leg to remove a gangrenous toe. He is reported to have lost a considerable amount of weight and is fighting a systemic staphylococcus infection. Sources close to the former FDAer say he faces possible further operations and at least a six month period of hospitalization and rehabilitation. Seife's saga is generating high-profile mass media attention in the nation's capital. The Washington Post ran a front-page, feature length article in its April 3 edition under the headline "The Bungled Punishment of Prisoner Seife." FDA congressional watchdogs also have taken an interest in the case. During the week of March 9, Rep. Dingell (D-Mich.) sent a letter to U.S. Attorney General William Barr inquiring into the circumstances of Seife's medical condition. Barr has not yet responded to Dingell. Sen. Hatch (R-Utah), who got to know Seife during the hearings on the 1984 Waxman-Hatch Patent Restoration Act, has also offered support through Seife's lawyer.

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