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Executive Summary

DRUG EXPORT BILL's FATE HINGES ON PMA "COOPERATION," according to observes of eleventh hour negotiations on Capitol Hill, as Congress attempts to dispose of pending legislation before adjournment. All impediments to a compromise export bill have been removed, except one -- a provision sought by Rep. Waxman (D-Calif.) to require drug manufacturer cooperation in a study of drug labeling worldwide. One of Waxman's conditions for agreeing to drug export legislation has been that any law must require a study of how drugs are labeled and marketed differently in developing vs. developed countries. The congressman initially proposed that the study could be conducted by the congressional Office of Technology Assessment. That study would have required the full cooperation of drug manufacturers in supplying labeling and promotional materials used in various nations and in documenting the basis for country-to-country differences. Industry rejected the proposal. On Oct. 2, Sen. Hatch (R-Utah), Senate sponsor of drug export legislation (S 1848), and Vice President Bush asked Waxman to consider a provision that would not require industry cooperation in a labeling study. Waxman did not change his position. One proposal offered during subsequent negotiations would require manufacturers to provide their labels initially, but would not require further industry cooperation in the study. The proposal is still under consideration. Industry is said to be willing to accept the proposal if it stipulates that the study focuses on U.S.-produced drugs and not products developed overseas and marketed elsewhere. Additionally, manufacturers reportedly are insistent that any such study should make no independent judgment on the validity of foreign labels. Other obstacles to passage of a drug export bill have been cleared. Manufacturers objected to two amendments -- involving infant formula and requirements for notification to foreign countries -- that were added to S 1848 when it passed the Senate. The infant formula amendment passed the Senate Sept. 30 as part of the anti-drug abuse bill and is consequently no longer an issue for export legislation. Sen. Glenn (D-Ohio), who sponsored the other amendment, has agreed to change it so that it will not apply to substances regulated by FDA. As it passed the Senate, the Glenn amendment required notification of foreign governments when a chemical exported from the U.S. has been subject of regulatory action. However, notwithstanding Glenn's acquiescence, the amendment could still jeopardize an end-of-session effort for quick passage because it requires legislative review by the House Foreign Affairs Committee. Although an export bill passed the Senate last spring ("The Pink Sheet" May 19, p. 3), the hearing and markup process has not begun in the House. Consequently, the unanimous consent of all concerned parties on a bill void of controversy will be needed for export legislation to be rushed through Congress at the close of the current session. Congress had targeted Oct. 3 for adjournment; however, some Capitol Hill observers are predicting the session could be extended through Oct. 11. Furthermore, there is some talk about delaying adjournment until after the Oct. 11-12 Reagan-Gorbachev summit meeting to consider arms control legislation. Nenetheless, members of Congress are eager to end the session in order to prepare for re-election battles in November.

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