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Executive Summary

ANDA FAVORITISM GRAND JURY INVESTIGATION could lead to indictments at the beginning of March, Bolar CEO Robert Schulman indicated at a generic industry conference sponsored by the investment firm Swergold Chefitz and held in New York Feb. 7. In response to a question from the audience on the status of the investigation, Schulman noted: "The gossip was, it was going to happen before Christmas; and, now, I hear February or March." Schulman's comments mirror Washington expectations about the indictment. Rep. Dingell's House Commerce/Oversight Subcommittee is reportedly waiting for the grand jury to finish its work before calling a hearing on the subject. The hearing could come very quickly after the grand jury's investigation is publicly disclosed. The grand jury investigation in Baltimore and the House subcommittee's work are concerned with allegations of payments to gain expedited reviews by FDA for generic drug applications. The probes reportedly have been more revealing than was initially anticipated. When the investigations were first made public, a handful of firms, one FDA reviewer, an industry consultant, and a generic stock analyst were said to be implicated. In addition to the firms that are known to be involved in the investigation -- American Therapeutics, Par, and its injectables subsidiary, Quad -- executives from at least three other generic manufacturers are understood to be associated with the investigation.

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