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Executive Summary

HALSEY WILL PAY $2.5 MIL. AND PLEAD GUILTY TO FIVE CRIMINAL CHARGES in an agreement reached with the Maryland U.S. Attorney's Office, Halsey Drug reported June 21. Under the agreement, which as of June 25 had yet to be filed with the Baltimore federal court, Halsey will pay a $2.5 mil. fine over five years and plead guilty to five counts relating to the addition of unapproved inactive ingredients to generic drug products. The agreement is subject to court approval after filing. In connection with the agreement, Halsey President and CEO Jay Marcus has resigned as a company officer and director. Halsey Senior VP and Chief Financial Officer Rosendo Ferran replaces Marcus as CEO. Jay Marcus has served as president of the publicly traded generic drug manufacturer and marketer since 1985, and is among several family members who head up the company. He is the son of Seymour Marcus, who is vice chairman of the board. Alexander Marcus serves as chairman of the board. In addition to the criminal charges, Halsey is in the process of responding to issues raised by FDA during recent inspections of it Brooklyn manufacturing facility. Halsey "is unable to predict at this time what actions the FDA may take," the company said. Halsey has hired a new head of legal and regulatory affairs "who will have regulatory oversight responsibility at the Brooklyn plant." The company did not name the new exec. Halsey has been under scrutiny for fraud since House Energy & Commerce/Oversight Subcommittee Chairman Dingell's (D-Mich.) generic drug industry investigations during 1990-91. Dingell alleged that Halsey had submitted ANDAs containing false statements to FDA ("The Pink Sheet" Sept. 2, 1991, T&G-7). In March and April, Halsey recalled five products for use of unapproved ingredients ("The Pink Sheet" May 17, T&G-17 and May 3, T&G-12). They include: acetaminophen and codeine phosphate tablets; metronidazole tablets; propylthiouracil tablets; propoxyphene napsylate and acetaminophen tablets; and quinidine gluconate extended-release tablets.

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