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GENERIC DEBARMENT BILL HEARING "POSSIBLE" IN DECEMBER

Executive Summary

GENERIC DEBARMENT BILL HEARING "POSSIBLE" IN DECEMBER before Rep. Dingell's (D-Mich.) Energy & Commerce/Oversight Subcommittee, staffer Claudia Beville told an Oct. 8 National Pharmaceutical Alliance meeting. Beville said the subcommittee is "in the discussion phase" concerning a new hearing. She said there is "a fairly good likelihood" of another hearing "depending on whether or not the debarment bill is going to be addressed in the Senate." Beville said the subcommittee had picked up "important information regarding both the enforcement process and the approval process" during a field visit to San Juan, Puerto Rico. "We are turning over a lot of rocks in inspection reports," she added. "Any snakes, worms, or other creatures of the dark would well be advised to find other regulatory statutes to slide under." Despite Dingell's announcement at a Sept. 12 FDA enforcement hearing that he would be redirecting his attention toward possible HHS and White House Office of Management & Budget obstruction of FDA enforcement efforts, Beville's comments at the NPA meeting indicate that the Michigan congressman is still willing to revisit generic drug industry hearings this year if the progress of a companion measure to HR 2454 is stalled in the Senate. Dingell's generic debarment bill was passed out of the full Energy & Commerce Committee on Sept. 25 despite industry opposition to the measure ("The Pink Sheet" Sept. 30, T&G-11). Industry lobbyists are now focusing on the Senate where Sen. Metzenbaum (D-Ohio) is developing broader debarment legislation. Regarding Dingell's interest in taking a closer look at HHS, Beville said that the subcommittee has "had concerns that the [HHS] Office of General Counsel will frequently delay an enforcement action; for what reason I'm really not quite sure." She warned, however, both HHS and the general counsel's office "can expect a healthy dose of sunshine." The subcommittee, she noted, also intends "to make sure" that neither the Office of General Counsel nor FDA makes "sweetheart" deals that allow companies to avoid seizures, injunctions and criminal investigations in return "for a promise of compliance." She added: "We have seen too many cases . . . where promises were made by companies but those promises never came into being." Beville warned that "in the future" the subcommittee is "going to be cracking the door in the area of examining Good Laboratory Practices." The subcommittee, she noted, has received "concerns emanating from field inspectors that this is one area that has not been examined closely." Two of the subcommittee's concerns, she added, are "whether . . . [FDA] has competent personnel to look at [GLP compliance]," and that some companies may not have GLPs in place. In addition, Beville reported, Rep. Dingell "will be monitoring very closely the implementation" of FDA's program to hire 100 new criminal investigators. "The agency does not have much experience in the area of training criminal investigators," she said. "We will be watching closely to make sure [FDA's] hiring process attracts and keeps the best cops available." Dingell also is concerned that the grade structure for the criminal investigators is "grossly inadequate," Beville said. Noting that the "top cop" is currently designated to be a grade 15 government employee, Beville reported that the Michigan congressman has urged HHS Secretary Sullivan to make the chief criminal investigator "at least an SES [Senior Executive Staff] position" to give the position "stature within the agency."
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