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IoM ROUNTABLE ON AIDS DRUG DEVELOPMENT IS POSSIBLE FORUM FOR ADVICE TO FDA ON CLINICAL ENDPOINTS FOR AIDS DRUGS; NIH VACCINE PLAN DUE OUT BY JAN. 1

Executive Summary

The Institute of Medicine's planned roundtable on AIDS drug development may be the appropriate forum for advice to FDA on clinical endpoints for AIDS drugs, National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci, MD, suggested at NIH's AIDS Program Advisory Committee meeting Dec. 5. Fauci recommended use of the roundtable meeting for that purpose in response to a plea from FDA Commissioner Young for a mechanism to generate and collect input from academia, industry, and government on efficacy endpoints for AIDS drugs. According to an IoM description of the roundtable, which will have a sister group that will focus on the development of AIDS vaccines, the goal of the panel "will be to facilitate direct communication among interested parties from different sectors about the means to promote the earliest possible availability of therapy and prophylaxis." The first meeting of the IoM roundtable is expected to be held sometime in early 1989. PMA is among the sponsors of the IoM roundtables. Other sponsors include: the Public Health Service (PHS), the Veterans Administration and the U.S. Army. Both the drug and vaccine panels on the roundtable will have eight members, including "representatives at the highest level of the NIH, FDA, and other relevant agencies, pharmaceutical companies, academia, and potential recipients of drugs and vaccines," the IoM document states. Each panel will plan and conduct meetings twice a year. In response to comments from Young about the necessity for having frequent and expeditious meetings that would focus specifically on clinical endpoints, a representative of the institute noted that the roundtable will have the ability to spin off workshops or conferences when necessary. Young identified the need for involvement of the academic community as one the highest priorites in FDA's plan for expediting AIDS drug approvals. The Commissioner also pointed to the growing pressures on FDA to approve AIDS drugs, and the resulting urgency the agency feels in developing appropriate clinical endpoints. Referring to the pressure the agency is under, Young said: "Having been on the outside [of government] for all of my life, I want you to know that the level of intensity when you're inside the agency, when you're trying to deal with this problem, when you're dealing with congressional oversight, when you're dealing with groups on various sides of the issue, are orders of magnitude different than the quarter of a century I spent in academia." To "merely say `When are we going to get these endpoints?' without getting a consensus and really slugging through and arguing out, puts FDA in a spot it shouldn't be in alone," Young continued. "We need our collective minds saying what the surrogate endpoints should be.... Somehow I've got to get the academic community engaged." Citing as an example the difficulty of conducting controlled clinical trials with aerosol pentamidine due to widespread unapproved use of the product, Young also stressed FDA's need for an outside group of experts that are available to discuss specific issues as they come up. "One of the concerns [with aerosolized pentamadine] is how do you gather additional information in a well constructed clinical trial. I would love to have guidance on just that point," Young said. "Thrashing around, trying to figure out how to design trials, and then leaving FDA with a wastebasket of yet unresolved issues is not helpful." Reporting on other developments in the AIDS area, Fauci noted that the National Institutes of Health's AIDS vaccine plan should be released by the first of January. The vaccine plan is part of an effort to chart a national strategy for AIDS vaccine development and evaluation. The plan includes the establishment of a blue-ribbon AIDS Vaccine Development Advisory Panel to review issues concerning vaccine production, reagent distribution, technology transfer and resource allocation involved in AIDS vaccine development. According to the proposed NIH plan, the panel would "be composed of representatives from PHS, academic institutions, pharmaceutical companies, biotechnology companies, the World Health Organization (WHO) and other institutions, and would...review and advise NIH on prioritizing resource allocation for AIDS vaccine development." The NIH plan also proposes that establishment of a "national AIDS vaccine scale-up facility be considered only in the event that private sector resources are not available for commercial scale-up." APAC agreed that a scale-up production facility should be pursued only as "a last resort after all other options have been exhausted," including federal contracts to private industry. Among other recommendations, APAC suggested that the vaccine plan adopt WHO's "proviso that any new candidate U.S. vaccine not be tested in developing countries unless Phase I trials have also been conducted in this country." APAC also proposed that the plan include several passive immunotherapy projects.
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