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NIH WAIVER OF IND RESTRICTIONS OPPOSED BY REP. DINGELL

Executive Summary

NIH WAIVER OF IND RESTRICTIONS OPPOSED BY REP. DINGELL in a Sept. 22 letter to House HHS Appropriations Subcommittee Chairman Natcher (D-Ky.). Energy & Commerce Committee Chairman Dingell (D- Mich.) urged House rejection of the waiver amendment, which was added by the Senate to the fiscal 1993 HHS appropriations bill (HR 5677). Dingell said the waiver "would authorize the [National Institutes of Health] to grant exemptions for drug investigations on humans to any licensed physician" and permit physicians "to administer investigational drugs to patients." Because only FDA is authorized by law to grant IND exemptions, he maintained that the Senate amendment is "an extremely significant change in current law and is plainly not appropriate on an appropriations bill." The letter cites a series of Senate amendments, which Dingell said should be deleted from HR 5677 on the grounds that they change "substantive law" within the jurisdiction of his committee. One amendment, authored by Sen. Hatch (R-Utah), would postpone FDA issuance of dietary supplement labeling regs as required by current law (see related story, p. 7). Another amendment opposed by Dingell would authorize HHS "to accept the donation of a specific experimental vaccine," Bristol- Myers Squibb's HIVAC-1e AIDS vaccine, "and to provide full indemnification of the manufacturer." BMS discontinued development of the vaccine in October 1990, saying the product was safe and showed "some immunogenicity but was not a desirable vaccine concept." The Michigan Democrat argued that "there is no authority for such action." In addition, he contended, "a number of complicated questions" related to the amendment "merit full examination before action." For example, he said, "the ad hoc nature of the remedy for a specific product, the budget implications of indemnification and the legal questions of indemnifying against all liability." Dingell sent Natcher a supplementary letter Sept. 23 asking that the House conferees reject a Senate amendment that would "protect children from exposure to environmental tobacco smoke in the provision of children's services. The amendment is "identical" to a House bill (HR 5815) that "was referred solely" to the Dingell committee on Aug. 11, 1992, the letter states. The Michigan Democrat said that, although he "may be sympathetic to some of the concerns expressed by HR 5815," the initiative is not "warranted through an appropriations bill and without hearings." In a similar letter to the Appropriations Committee, Dingell urged that the House-Senate conference on the 1993 Defense Department appropriations bill delete an amendment that would provide $20 mil. for large-scale Phase III testing of another AIDS vaccine.
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