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Executive Summary

GENERIC DRUG REPORT WITH LEGISLATIVE RECOMMENDATIONS is expected to be released in the first quarter of 1990 by the House Commerce/Oversight Subcommittee. The Oversight Subcommittee staff will then work with the Health Subcommittee staff on developing formal legislation later in the year. Oversight Subcommittee member Rep. Wyden (D-Ore.) predicted Oct. 23 that legislative efforts will "start moving" a "very strong bill" by "early next year." Participating on a D.C. radio talk show, Wyden said the subcommittee, at a hearing scheduled for Nov. 17, will receive "a status report from the FDA in terms of those 30 [generic] companies" inspected. Wyden said legislation will be enacted to make "very dramatic" changes in the ANDA review and approval process. One of the changes will be establishment of "increased penalties . . . including debarment." "We're going to stiffen FDA's powers for recall," the Oregon Democrat said. To illustrate the need for heightened recall powers, Wyden noted that breakthrough seizures were attributed to Pharmaceutical Basics' carbamazepine while the agency was trying to persuade the company to upgrade its recall. "There were real questions, for example, in the epilepsy situation about some problems that actually occurred in the middle of a recall," he said ("The Pink Sheet" Oct. 2, p. 15). The subcommittee will also press for increased FDA resources to beef up its enforcement staff, according to Wyden. * The Pharmaceutical Manufacturers Association, in preparation for a congressional reopening of the FD&C Act, is forming a committee to re-examine the law and identify provisions that are likely to be addressed in legislation. The PMA panel will be headed by Schering Laboratories President Jean-Pierre Garnier. Changing the post-1962 ANDA provisions of 1984 to correct problems uncovered by the generic drug investigations could open Pandora's box for industry if Congress exploits the opportunity to enact crisis atmosphere amendments and/or looks elsewhere in the FD&C Act for changes.

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