U.S. ATTORNEY WILLCOX, ASST. JORDAN TO TESTIFY AT REP. DINGELL’s DEC. 19 HEARING

The two prosecutors in the continuing Justice Department investigations of the generic drug industry, U.S. Attorney Breckinridge Willcox and Assistant U.S. Attorney Gary Jordan are scheduled to update, Rep Dingell's (D-Mich.) House Oversight Subcommittee in a hearing on Dec. 19. The two Baltimore federal district prosecutors will appear on the first panel of the hearing. Willcox, whose term in office is expiring, is expected to deliver a parting shot against generic manufacturers. The prosecutor has not shied from vitriol in past comments on the industry. In a statement issued when American Therapeutics was sentenced in the Baltimore federal court, Willcox said the "depressing and sinister picture of the generic drug industry...will get even darker" as the investigation reveals that the firm's conduct "was altogether commonplace, and in many ways even benign, when compared to some of its competitors" ("The Pink Sheet" Oct. 22, p. 10). The second panel will comprise three FDA enforcement officials: the agency's Compliance Office Director Daniel Michels, Manufacturing & Product Quality Division Director Edmund Fry, and Compliance Office staffer Paul Vogel. Fry and Vogel have been directing the agency's special task force on generic drug industry investigations. Subcommittee Chairman Dingell cancelled another hearing that had been scheduled for Dec. 12. However, there is a chance that the hearing, which was to have addressed FDA/industry relations and their effect on drug approvals, will be rescheduled for Dec. 14 or 20.