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FDA DEBARMENT BILL: KENNEDY AND HATCH SUPPORT SOUGHT

Executive Summary

FDA DEBARMENT BILL: KENNEDY AND HATCH SUPPORT SOUGHT for HR 4810 to be introduced "soon" by Reps. Dingell (D-Mich.) and Bliley (R-Va.). In a Jan. 2 letter the House Oversight subcommittee chairman and ranking Republican said they "intend to introduce similar legislation soon after the next Congress is converted and look forward to working with both [Sens. Kennedy (D-Mass.) and Hatch (R-Utah)] to address these issues." The two congressmen noted that their aides and the senators' staffs "worked diligently" together "under incredible time pressure in pursuit of a compromise on HR 4810 at the end of this past Congress." The 102nd Congress formally convened Jan. 3 but will not begin regular business until Jan. 23; in the interim the legislature has been addressing the Persian Gulf crisis. The new legislation reportedly might be expanded to provide debarment and ANDA suspension penalties for firms guilty of severe regulatory violations as well as for payoffs, fraud and false statements. However, the Oversight Subcommittee is expected to continue to resist legislation that includes debarment or suspension penalties affecting the development of pioneer innovator drugs. "Since May," when Kennedy and Hatch were asked to cosponsor HR 4810, "the generic drug investigation has continued and additional problems at the FDA, in generic manufacturers and their consultants, and in testing laboratories have been uncovered," the letter continues. The generic drug industry "is the most pervasively corrupt group of firms examined by the subcommittee," the representatives said. They added: "legislation is needed now more than ever to stem the loss of public confidence in generic drugs and in FDA enforcement." The two congressmen suggested that debarment and suspension penalties must be strong enough to put "scofflaws" out of business and that an expedited ANDA approval process and pharmaceutical cost containment depend upon such enforcement power. "It is very clear that the FDA presently cannot handle generic drug applications efficiently," they maintained. "If the strong penalties such as those contained in HR 4810 are in place to drive scofflaws from the market, it may be possible to reform the FDA approval process to permit greater reliance on applicant certification rather than on the atrophied review process at the agency. Without such sanctions, it may be necessary to reconsider the abbreviated nature of the approval process that provided too much temptation to industry scoundrels at the same time it provided needed lower cost medicine to millions of Americans," the letter states. "Without a workable approval process and a trustworthy generic industry, generic drugs cannot provide the price competition envisioned by Congress in 1984," when it passed the post-1962 ANDA/patent restoration act.
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