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Executive Summary

HOUSE DRUG DIVERSION BILL PASSES COMMERCE/HEALTH SUBCMTE. at a Sept. 23 markup session. Subcommittee Chairman Waxman (D-Calif.) noted that the markup was held at the request of Commerce Committee Chairman Dingell (D-Mich.), who introduced the legislation (HR 4820) four months ago. Dingell offered a substitute bill compromising minor technical changes, which passed. The substitute retains a provision, opposed by the Pharmaceutical Manufacturers Association, to ban distribution of prescription drug samples by detail personnel. The subcommittee meeting was delayed until an agreement was reached among members that the bill will not be brought before the full committee until Sept. 30 at the earliest. Dingell noted that Reps. Madigan (R-Ill.) and Leland (D-Texas) have outstanding issues to be resolved. Madigan reportedly objects to the provision that would restrict sampling to direct mail distribution in response to written MD requests. Leland, a pharmacist, reportedly wants samples to be dispensed through pharmacies only. PMA and the American Pharmaceutical Association respectively endorse those positions. Should Leland and Madigan fail to agree on the sampling issue, Dingell has several legislative options. The Michigan Democrat could remove the sample distribution provision from the bill altogether in order to get the legislation passed by Congress this year. Removing the one controversial provision would enable the House to pass the bill without debate under suspension of the rules; the legislation could then be forwarded directly to the Senate floor if there is no objection. However, Dingell reportedly would rather leave the current bill unchanged. Its sampling provision represents a middle ground between Madigan's and Leland's positions. But because HR 4820's sampling provision would significantly increase the costs of sampling, the bill will be opposed and, at this point in the legislative calendar, blocked from passage. Since the measure was introduced, Capitol Hill observers have said that Dingell's plan is to introduce legislation next year comprising a harsher provision, possibly banning physician samples, if industry does not accept HR 4820. The congressman can bolster his position next year by demonstrating that his bill went through the markup process only to be resisted by special interests that objected to what was in fact a compromise provision. Companion legislation was introduced in the Senate on Sept. 24 by Sen. Matsunaga (D-Hawaii) and nine cosponsors. However, Matsunaga's bill (S 2875) contains the sampling provision. Labor & Human Resources Committee Chairman Hatch (R-Utah) is not expected to take legislative action this late in the congressional year on a new bill unless it is noncontroversial.

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