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FDA ENFORCEMENT BILL EXPECTED TO BE REINTRODUCED THIS YEAR IN SAME FORM AS LAST YEAR'S MEASURE, HILL STAFFER SAYS; FDA DRAFTING CIVIL PENALTY HEARING REG

This article was originally published in The Gray Sheet

Executive Summary

Rep. Henry Waxman (D-Calif.) is likely to reintroduce a bill to enhance FDA's enforcement powers that will be very similar to a measure (HR 3642) he sponsored last year, House Energy and Commerce health subcommittee counsel William Schultz indicated at a March 24 Food and Drug Law Institute meeting in Washington, D.C. "We haven't worked out exactly what form it will take," Schultz said, but "a lot of [the bill] was done last year and we certainly don't intend to just start over" with an entirely new bill. The staff of the subcommittee, which is chaired by Waxman, will craft a new bill "after conversations with the [Clinton] Administration" in order to "make a determination where they want to go," Schultz explained. Earlier this year, Schultz urged support for FDA enforcement legislation in a report to the incoming administration. HR 3642 cleared the full House Energy and Commerce Committee in July ("The Gray Sheet" July 13, 1992, p. 5) but died before reaching the House floor. A Senate version of the bill (S 2135), introduced by Sen. Edward Kennedy (D-Mass.), never reached the Senate Labor and Human Resources Committee for consideration. In addition, the legislation faced an uphill battle because of the Bush Administration's promise of a presidential veto and Sen. Orrin Hatch's (R-Utah) concern with the legislation's impact on nutritional manufacturers. At the FDLI meeting, FDA Deputy Chief Counsel for Regulations and Hearings Linda Horton speculated that the legislation's chances have improved given that "the new administration's views [may] more clearly resemble FDA's traditional views" of its enforcement role. A reintroduced bill "will receive serious attention" in the current Congress, she suggested. "It might actually be passed." Horton also told the FDLI audience that "in the near future," FDA expects to publish a proposed rule establishing "hearing procedures for civil money penalties." She said that the proposal was drafted as "part of an effort to put in place internal agency mechanisms for...administrative enforcement powers," such as civil penalties, mandatory recalls and debarment. Civil penalties and mandatory recalls were authorized under the Safe Medical Devices Act of 1990. She said that the agency is concerned that "some of the hearing procedures we have now are not particularly well suited for administrative enforcement." Current hearing procedures are "really written with product withdrawals in mind or product denials of approval in mind," Horton explained. However, the upcoming proposal's hearing procedures "more closely resemble the complaint-and-answer approach that is familiar in civil court litigation."
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