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Executive Summary

Vice-President Bush's selection of Indiana Senator J. Danforth Quayle as the GOP vice-presidential candidate adds a figure with experience in FDA and health legislation to the 1988 national election campaign. As a member of the Senate Labor & Human Resources Committee for almost eight years, Quayle (R-Ind.) has had a steady exposure to legislative issues in the health field and has participated prominently in the development of several bills. During his tenure on the committee, a number of major pieces of drug legislation moved through the committee including the orphan drug legislation of 1982, the patent term restoration bill in 1984, and the drug export and vaccine compensation legislation in 1986. Recently, Quayle has taken a surprisingly active role in legislation in the medical device field. He has sponsored two device-related bills and has been active in the debate over a third, a transitional device bill sponsored by Sen. Bumpers' (D-Ark.). In 1987, Quayle spearheaded the Reagan Administration's opposition to Rep. Waxman's (D-Calif.) bill to amend the 1976 Medical Device Act. Quayle introduced S 1928, which would have eliminated a regulatory classification for devices to be controlled by performance standards and folded those devices into an existing lesser level of regulatory control. Earlier this year Quayle agreed to Sen. Gore's (D-Tenn.) bill to require Senate confirmation of FDA commissioners. He had a hold on the measure when the Reagan Administration objected to it. Gore's bill passed the Senate by unanimous consent in February after Quayle and the Administration met with Gore, agreed to minor amendments, and removed their objections. The legislation has returned to the Senate with Waxman's device law amendments, which were added by the House ("The Pink Sheet" Aug. 1, "In Brief"). Also in 1987, Quayle sponsored legislation to make polygraphs subject to the provisions of the medical device law. Most recently, he has been a vocal opponent of a provision in the bumpers bill that would automatically place nonhydrophilic plastic contact lenses into a new regulatory class -- and permit new firms to market those products with less regulatory hurdles. Quayle was in line to head the Senate Labor & Human Resources Committee in 1986 before the Democrats regained control of the upper chamber. He is often perceived as an open antagonist of Sen. Kennedy (D-Mass.) who received the committee chairmanship with the change in the Senate majority. In one speech to a health-care audience soon after the election, Quayle painted a grim outlook for the health care industry based on Kennedy's decision to take the health Subcommittee chairmanship. Quayle is now the third-ranking Republican on the committee and the senior minority member on the Labor Subcommittee. As an Indianian, Quayle took a major part during 1985 in the support for the confirmation of former Indiana Gov. Bowen as HHS secretary. In the past, Quayle has also been drawn into some health issues by his responsiveness to major Indiana firms, such as Lilly. By an unusual coincidence, Vice President Bush also has an affiliation with Lilly. He was briefly on the company's board at the end of the 1970's before entering national politics. At the start of the Senate's consideration of an outpatient drug benefit in the spring of 1987, Quayle addressed the Pharmaceutical Manufacturers Association annual meeting and espoused the view that the drug benefit proposal could be forestalled by proposing further studies of the plan. ("The Pink Sheet" May 25, 1987, p. 12). Quayle's remarks discounted the drug benefit's election-year momentum, which eventually made some form of the program virtually unbeatable. Quayle, however, was not a direct participant in the development of the catastrophic health care bill and the drug benefit program. He is not a member of the Senate finance committee, which had jurisdiction over the legislation. Quayle's opposite on the Democratic ticket, Sen. Bentsen (D-Tex.), took one of the leadership roles in the development of the catastrophic care bill as co-sponsor and chairman of the Finance Committee. Bentsen favored the concept of the outpatient drug coverage from the beginning of the Senate's consideration, but advocated a go-slow approach. The Texas Democrat was accessible to differing approaches to the benefit and was one of the prime targets for PMA lobbying on the issue. Both Quayle and Bentsen ultimately voted for the catastrophic care/drug benefit.

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