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Executive Summary

The Drug Export Bill was passed by the Senate Labor & Human Resources Cmte. on Nov. 19 by a vote of 13-2 with one abstention. The measure (S 1848), sponsored by Cmte. Chairman Hatch (R-Utah) and cosponsored by Ranking Minority Member Kennedy (D-Mass.), will be reported to the Senate floor. Sens. Metzenbaum (D-Ohio) and Matsunaga (D-Hawaii) voted "no" while Sen. Weicker (R-Conn.) abstained. The cmte. accepted one amendment that was offered by Sen. Simon (D-Ill.) and would reduce from three to two years the bill's deadline for the General Accounting Office to report on the effectiveness of provisions to prevent transshipment. Metzenbaum requested and was granted time until Dec. 3 to produce a dissenting view for inclusion in the cmte. report. Metzenbaum said he opposes the bill, which would allow the export of drugs made in the U.S. but not appproved by FDA, as establishing "an immoral double standard." The Ohio Democrat had prepared 20 amendments. Acknowledging the fact that he did not have the votes for any of them to succeed, he did not offer them for the cmte.'s consideration. Metzenbaum said he would instead introduce them on the Senate floor. However, Simon, who voted for the bill, declared that "a number" of Metzenbaum's amendments warranted consideration. Commenting that any legislation can be improved, Hatch agreed to negotiate with Simon and Metzenbaum after the bill was reported out of the cmte. One of Metzenbaum's amendments would include antibiotics under the bill's provisions. Unapproved antibiotics manufactured in the U.S. can be exported currently. Consequently, the amendment would restrict the export of unapproved antibiotics by placing them under the bill's controls. Hatch commented that the amendment effectively would kill the measure. When Hatch introduced the legislation, he remarked that the restrictions incorporated to gain Kennedy's support make "the bill perhaps more encumbered than I might think necessary." Additional restrictions could "make future investment decisions so risky that the new shipment authority would not be used," he suggested. Some of the Metzenbaum amendments, if added at a later date, would change the character of the bill enough to jeopardize continuing support for the measure among the current backers. Another Metzenbaum amendment would permit exports only to "Tier I" and not to "Tier II" countries, although it would make an exception for the export of tropical disease treatments to other countries. One amendment would allow export of only those unapproved drugs for which an NDA had been filed at FDA; the Hatch bill requires IND approval. Metzenbaum would also amend the legislation to include a two-year sunset provision.

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