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Executive Summary

BOLAR FORMER EXEC VP RIVERS FACES POSSIBLE $1 MIL. FINE and a four- year prison sentence if the Maryland U.S. Attorney's Office planned sentencing request is granted. Jack Rivers, 63, pled guilty April 15 to two counts of making false statements to FDA and one count of obstructing an FDA investigation of the generic drug firm. Sentencing is set for July 1 before Baltimore Federal Court Judge John Hargrove. The Maryland U.S. Attorney's Office said it plans to recommend a four-year prison sentence without parole in addition to a $1 mil. fine. The case against Rivers included evidence presented by the Maryland U.S. Attorney's Office and the Justice Department's Office of Consumer Litigation that the former Bolar exec was responsible for submitting false data to FDA "in a number of Bolar drug applications." The fraudulent applications included results of rigged bioequivalence tests; false testing data from fictitious R&D batches; and false data on the manufacturing site and raw materials used in R&D batches. Rivers was originally charged with six counts of making false statements to FDA, three counts of obstructing agency investigations and one count of conspiracy. The three counts to which he agreed to plead guilty involve generic versions of SmithKline's Dyazide (triamterene/hydrochlorothiazide) and Norwich Eaton's Macrodantin (nitrofurantoin). Sales of Bolar's generic Dyazide totaled $140 mil. during its 2-1/2 years on the market; the Bolar drug was recalled in February 1990. Rivers admitted to substituting Dyazide for Bolar's generic version in bioequivalence tests conducted by testing lab PharmaKinetics. Rivers also pled guilty to inventing data for an FDA-requested dissolution test for nitrofurantoin that was never actually conducted. The obstruction conviction centers of Rivers' involvement in persuading a PharmaKinetics official to allow Bolar to replace retained samples of the disguised Dyazide with Bolar capsules two days prior to a June 1989 FDA investigation ("The Pink Sheet" June 24, T&G-15). Separately, on April 13 Vitarine Pharmaceuticals pled guilty to four counts of shipping adulterated drugs in interstate commerce and was fined $2 mil. by Judge Hargrove. The Vitarine conviction, based on the fraudulent activities of former VP-R&D Steven Colton and former VP-Manufacturing John Bushlow, completes the investigation of the Springfield Gardens, NY- based firm. Colton is serving a 27-month sentence for actions including making false statements and substituting six innovator drugs, including Dyazide, for Vitarine's generic versions in submissions to independent bioequivalence testing labs ("The Pink Sheet" Sept. 9, T&G-8). Bushlow received an eight-month sentence for using an unapproved manufacturing process to produce bulk cephradine.

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