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Executive Summary

FDA ENFORCEMENT BILL: DEBARMENT PROVISION REMAINS IMPEDIMENT to an agreement between the staffs of Reps. Dingell (D-Mich.) and Waxman (D-Calif.) on compromise legislation. Aides for the legislators have been negotiating for weeks on amendments to HR 4810 in an effort to get Health Subcommittee Chairman Waxman (D-Calif.) to sign onto the bill. Waxman is one of only five of the 43 House Energy & Commerce Committee members to decline to cosponsor the legislation when it was introduced by Committee and Oversight Subcommittee Chairman Dingell (D-Mich.). Reportedly, the two staffs had reached a tentative agreement on a new discussion draft for HR 4810 early on Sept. 7; however, by mid-afternoon differences remained. Dingell's staff acknowledged that the impasse involved the debarment provisions and suggested that the Michigan Democrat would be unlikely to make further concessions on the issue. Several changes to HR 4810 have been discussed. One change said to be potentially acceptable to both sides would add civil monetary penalties for brandname manufacturers that corrupt the new drug review process. Based on the findings from the generic drug investigation, HR 4810 currently provides penalties only for generic companies. Other changes to the debarment provisions would give FDA discretion to impose limited debarment or approval suspension penalties against generic firms and to reduce periods of debarment for generic firms that demonstrate efforts to "rehabilitate" themselves. The original Dingell bill provides minimum debarment periods of three years. At a June 28 hearing before Waxman's Health Subcommittee ("The Pink Sheet" July 2, p. 3), Generic Pharmaceutical Industry Association President Dee Fensterer noted that other government agencies with such authority have discretion in setting debarment periods and do so to protect public safety, not to punish the companies. Vitarine President Roger Jordan and Par President Kenneth Sawyer testified that debarment provisions should include incentives for companies to make institutional changes that would prevent future wrongdoing. Waxman's support for any House bill to enhance FDA's enforcement powers is considered crucial to obtaining the agreement of Sens. Kennedy (D-Mass.) and Hatch (R-Utah) of the Senate Labor & Human Resources Committee. If Waxman and Dingell reach full agreement, the legislation will still have difficulties in getting through the Senate. Sens. Hatch and Thurmond (R-S.C.), on behalf of HHS, jointly introduced S 2683, which would authorize FDA to debar any agency-regulated industry. Since the early summer, Kennedy and Hatch have been discussing an alternative bill to provide FDA with broad enforcement power.



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