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Executive Summary

Vice President Bush's endorsement gives FDA the official go-ahead to move quickly to develop a new policy for accelerated approvals of drugs to treat AIDS and other life-threatening diseases. Following a July 29 meeting between Bush, in his role as head of the President Task Force on Regulatory Relief, and FDA Commissioner Young, Bush's office issued a statement announcing that the vice president "strongly urged the development of new administrative and legislative proposals to speed the availability of new drugs for AIDS and other life threatening conditions for which adequate therapies are not available." The statement further noted that Bush "asked FDA Commissioner Frank Young, in consultation with the secretary of HHS," to develop proposals "as quickly as possible" that "permit FDA, in making decisions to approve new drugs, to consider the risks of the life threatening diseases to be treated in balancing both the potential benefits and the risks of the drug itself." FDA's Young has recently expressed a readiness to establish new regulatory policies for speeding and broadening the availability of treatments for life-threatening conditions. Ironically, the development of new AIDS drug approval procedures is one issue on which presidential candidate Bush and one of his most outspoken antagonists, Sen. Kennedy (D-Mass.), agree, at least in concept. Young testified at a July 13 hearing before Kennedy's Labor & Human Resources Committee in support of legislation authorizing FDA to require PhaseIV postmarketing studies in order to facilitate quicker approvals of drugs for AIDS and other diseases ("The Pink Sheet" July 18, p. 9). Kennedy declared his support for the Phase IV proposal, explaining that new procedures are needed to "clear up ambiguities" for AIDS patients and drug firms over the agency's Treatment IND regs, implemented last year. Bush's announcement could defuse a potentially damaging campaign issue. FDA and the Administration have been sharply criticized by AIDS interest groups as being unresponsive to the AIDS situation. However, substantive new proposals initiated by Bush and released during the campaign might turn a political liability to an asset. In addition, Young has tried to improve relations with the AIDS community. He recently told a prominent AIDS group that the agency is actively "considering" the idea of "conditional approvals" for AIDS drugs. Young also announced at the same meeting, the National Lesbian an Gay Health Conference and AIDS Forum, that FDA is allowing the importation by mail of unapproved drugs such as AIDS treatments, provided they are in small quantities for personal use ("The Pink Sheet" Aug. 1, p. 3). Bush has been involved in drug approval issues before. In adopting the Treatment IND regs last year, for example, FDA said that the agency had acted at the direction of Bush's regulatory task force. Bush also recently suggested that the President's Cancer Panel study FDA's current drug approval system and make recommendations for improvements. In a June 8 letter to the chairman of the panel, Armand Hammer, Bush asked for "a systematic study of drug regulation as it affects progress in developing and making available therapies for cancer and for AIDS, and . . . recommendations for improvements." In the letter, a copy of which was forwarded to FDA's Young, Bush further suggested that the panel develop a report which addressed such questions as: "Should approval criteria for [INDs and NDAs] for cancer or AIDS drugs be modified? What should be the appropriate end-points for assessing effectiveness of new agents for the treatment of cancer and AIDS? What degree of flexibility should clinical investigators have in modifying approved investigational studies that would accelerate the IND process based on early findings, and to what degree should protocol modifications require new approvals?"

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