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Executive Summary

Drug review times are an "unacceptable handicap" that the White House Council on Competitiveness will soon attempt to remedy, Vice President Quayle said in a June 24 address to the American Medical Association's House of Delegates in Chicago. Noting that "50% of the drugs approved in the U.S." in 1990 had already been approved in other countries," Quayle told the AMA meeting that the council "will soon make recommendations" to address that situation. Quayle calculated that, on average, these drugs had been available in the countries in which they were first approved for six years before they were available in the U.S. The Vice President chairs the Council on Competitiveness. "We will not sacrifice the safety or the welfare of our people," Quayle declared, "but we can, and we will, streamline the FDA process so that people who are suffering can get the healing new drugs that offer them help." A council working group, chaired by HHS Deputy Secretary Constance Horner and attended frequently by FDA Commissioner Kessler, has been examining the drug approval process since late 1990 and its report is expected this summer ("The Pink Sheet" Feb. 4, T&G-8). Separately, an internal FDA group exploring the conditional/expedited approvals concept has been in operation for several months. The FDA group is said to be awaiting the White House report before going any further. Quayle did not announce any new health care initiatives during his Chicago visit, but rather, his appearance seem geared to signaling that the Administration wants to maintain a role in the health care financing/access reform debate. Speaking generally about that debate, he said the "question of how to change the system will not be easy to answer. We've already witnessed to some extent what can result from a headlong rush into action. About two years ago," he noted, "the Medicare Catastrophic Coverage Act was enacted. Less than 18 months ago, it was repealed." The Vice President said the lesson from that experience is that "no solutions will be found from a simple-minded approach. Proposals to change the system will have economic and social consequences and must be thoroughly thought through." He added: "Beware of the modern-day traveling medicine shows that offer the magic fix. Let's face it: 'snake oil' can come in a bottle or in a campaign promise."

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