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BIOTECH DRUG EXPORT BILL BEING NEGOTIATED IN HOUSE WITH PMA BLESSING

Executive Summary

Representatives of the biotechnology industry are meeting with Rep. Waxman (D-Calif.) to forge export legislation limited to biotech products. The negotiations began after efforts toward a broader pharmaceutical export bill came to an apparent dead end in the House. With the remaining legislative days in the congressional calendar dwindling and Waxman and pharmaceutical industry negotiators at an impasse over the issue of a worldwide drug labeling survey, the biotech industry is seeking to negotiate narrower legislation to permit the export of genetically engineered medical products prior to FDA approval. Although biotech companies initially made the decision to join with the pharmaceutical industry in seeking export reform legislation, they reportedly have considered pursuing a bill independent from the drug manufacturers. Earlier in the year there was concern that the Pharmaceutical Manufacturers Association would actively seek to quash attempts to enact biotech-specific export legislation. However, PMA has reportedly indicated it will not try to block such a measure. Waxman has been publicly sympathetic to the biotech industry's need for relief from export restrictions. At a hearing on the issue before his Health Subcommittee last spring, Waxman said he hoped that Congress will "be able to address those very real problems" facing biotech firms ("The Pink Sheet" May 5, p. 10). The key sponsors of the export bill in the Senate, Hatch (R-Utah) and Kennedy (D-Mass.) are watching the House action. As of Oct. 10, Hatch was reportedly waiting to see whether the biotech bill could pass the House before deciding. The major stumbling block to a drug export bill in the House was Waxman's persistence on a provision to require PMA cooperation in the labeling survey while PMA rejected the idea from the start. In an attempt to salvage the legislation, Sen. Kennedy proposed that industry not be required to cooperate beyond an initial submission of labels used worldwide. Pharmaceutical firms indicated that the measure should stipulate that they should not have to justify or present evidence to support country-to-country differences in labeled indications or warnings for their products. PMA also rejected any proposals that would lead to independent judgments about the propriety of such differences.

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