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Executive Summary

FDA DEBARMENT BILL: LACK OF INDUSTRY INPUT IN LEGISLATIVE PROCESS carries a "big risk" that the pharmaceutical industry may wind up with a piece of legislation "with serious problems," House Energy & Commerce/Health Subcommittee counsel William Schultz warned Dec. 11 at the Food & Drug Law Institute's annual meeting. Observing that there was "very little real opposition and hard criticism...on the specifics of the bill, Schultz remarked upon the lack of industry comment even after subcommittee Chairman Waxman (D-Calif.) proposed that the debarment legislation extend beyond generic drug firms. "A lot of the lobbying that I saw was people coming into my office and kind of whispering 'you know we're really against this bill even though we don't want to say it publicly,'" Schultz noted. The House staffer advised that there is fairly strong support on Capitol Hill for strengthening FDA's enforcement powers,including debarring firms from agency programs. "The mood on Capitol Hill is that it is useful to punish corporations and that debarment is a useful idea," Schultz said. Schultz noted that debarment legislation remains "a high priority for Chairman Dingell (D-Mich.) and for the Energy and Commerce Committee." Dingell pushed legislation to enhance FDA's enforcement tools but, in an effort to take "emergency" action on generic drugs this year, had proposed to limit the bill's scope to generic drugs. In addition to Waxman, Sen. Metzenbaum (D-Ohio) had objected to the narrower scope. Metzenbaum is expected to introduce an agency-wide debarment bill early next year ("The Pink Sheet" Dec. 3, In Brief). Also addressing FDLI, former FDA counsel Richard Cooper (Williams & Connolly) blasted Dingell's legislation as "a radical new type of debarment legislation, punitive beyond any precedent in American legal history." Describing the debarment bill as a "harsh" and "misdirected" attack on companies rather than individuals, he argued that such an approach only provides greater incentive to cover up wrongdoing. Cooper contended that companies refrained from honest criticism of the bill because they fear political reprisal. "There's a climate of fear that there will be political costs to opposing this legislation...and those costs will be harsh," he maintained. FDA's long-awaited "rehabilitation policy" for the generics industry was also discussed at the FDLI conference. D.C. Attorney Alan Kaplan (Kleinfeld, Kaplan & Becker) outlined a draft of FDA's requirements for firms shown to be wrongdoers that want to regain their standing at the agency and participate in the drug approval process. These provisions, according to Kaplan, include suspension of a suspect company's NDA/ANDA approvals until FDA completes a thorough investigation that includes sample testing and audits; a market recall of all implicated products; the removal of all implicated individuals from substantive authority; compliance with good manufacturing practices; conducting an internal audit by objective outsiders to identify discrepancies between the original ANDA and rehabilitating documents; and a satisfactory review of the audit by FDA. Suspect generic firms also will have to demonstrate their good faith by providing appropriate assurances that FDA's investigations were not obstructed in any way. Additionally, the company CEO will have to submit a signed statement attesting to his or her firm's future integrity in pursuing a corrective action plan. Kaplan challenged the viability and legality of many of these provisions and also criticized FDA for its slowness in making public the nature of the rehabilitation program. "The rehabilitation policy is long-a-borning," he commented. He also remarked upon the program's name change within the agency. "While the term rehabilitation is a positive term and implies 'hope,' the new name has elements of discouragement. It is now referred to as 'the fraud policy,'" he said.

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