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Executive Summary

DRUG DIVERSION BILL NEGOTIATIONS ON SALES REP SAMPLING have moved towards an agreement on provisions of a proposed draft of House legislation sponsored by Rep. Dingell (D-Mich.). Pharmaceutical manufacturers and congressional staffs on Oct. 3 were said to be close to a compromise that could lead to a bill ready for consideration by Oct. 6. Early during the week of Sept. 29, Dingell offered a draft provision that would permit distribution of Rx drug samples by company sales personnel -- if the samples are requested in writing by physicians -- with strict storate, handling, and recordkeeping standards. The draft also provides criminal penalties and fines for violations of the requirements, particularly for bartering or otherwise diverting samples. The general counsels of the major drug makers met in New York on Oct. 2 to discuss the compromise provision. They agreed that negotiations should continue. On Oct. 3, the lawyers met again and concurred that their concerns had been addressed satisfactorily. The draft demonstrates Dingell's desire to move the bill before Congress adjourns. The Pharmaceutical Manufacturers Association has already adopted some of the compromise concepts in a voluntary code of standards for sampling. The primary concerns about Dingell's bill centered, in part, upon aspects of proposed penalties that involved company sanctions and enforcement provisions under the FD&C Act. Specially, the counsels argued that a CEO should not be culpable if a single salesman is corrupted. Dingell reportedly accepted their argument. Energy & Commerce Committee markup of the drug diversion bill (HR 4820), which had been tentatively scheduled for Sept. 30, has been postponed. If the Michigan Democrat can strike an agreement on the measure, he can introduce a clean bill on the House floor for passage under suspension of the rules; Sen. Matsunaga (D-Hawaii) or Sen. Broyhill (R-N.C.) could take a similar tack in the Senate. Such quick action will depend upon fashioning legislation that has the endorsement of all interested industry and professional parties. Currently, HR 4820 has the support of all groups but PMA, which objects only to the sample distribution provision. If Dingell must begin the legislative process all over again next year because PMA has rebuffed what he considers a major concession, it is expected he will push for legislation to ban completely the distribution of samples to physicians. If he has to start again, Dingell is also warning that he could hold a series of hearings involving a number of companies to investigate abuses of samples.

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