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"PARALLEL TRACK" WORKING GROUP WILL BE FORMED TO REFINE AND REVIEW PROPOSAL; INFORMAL GOVERNMENT/CONSULTANT GROUP WILL HOLD FIRST MEETING BEFORE AUG. 31

Executive Summary

HHS is forming a special standing committee representing both government and non-government constituent interests to help resolve disagreement over details of the proposed "parallel track" release of investigational AIDS drugs, HHS National AIDS Program Office Director James Allen, MD, told FDA's Anti-Infective Drugs Advisory Committee Aug. 17. HHS intends to choose members for the working group and convene a first meeting "before the end of August," Allen said. "The intent of our group," he explained, "is to take people nominated by [FDA Commissioner] Young, and by Dr. Bill Raub, acting director of the National Institutes Health." Preliminary plans call for the panel to be comprised of representatives from industry, the research and treatment community, the legal profession and patient advocacy groups as well as from FDA, NIH, the Health Resources Services Administration (HRSA) and the Health Care Financing Administration (HCFA). The Anti-Infective Drugs Advisory Committee met to discuss issues with the parallel track procedure that FDA wants to resolve before beginning the program ("The Pink Sheet" July 24, p. 16). The committee declined to make recommendations about the specifics of the proposed program, but unanimously endorsed the "parallel track" concept and recommended establishment of a committee that would work out the details of the program and respond to other issues as they arise during implementation. Summarizing the committee's recommendations, Calvin Kunin, MD, Ohio State University Department of Medicine, said: "I believe the consensus of the committee is that everyone of us is in favor of a parallel track system -- we have no problem with that. In order to flesh out the nature of it, [however], there have to be more meetings, either of the new committee appointed through the Office of the Assistant Secretary, or of this committee." In addition, Kunin continued, "there must be a staff assigned to implement the recommendations of that committee. That staff may well reside at the National Institute for Allergy and Infectious Diseases (NIAID), . . . it may be joint with the FDA, but there has to be a staff to really see that this thing gets done." * HHS had decided to form a separate working group prior to the advisory committee meeting. In the middle of the committee's discussion of the necessity for either further meetings or another committee to work out details of the program, Allen announced that HHS Assistant Secretary for Health Mason "has asked the National Program Office to take a convenor role in working with the FDA and NIH, and I think we've also clearly heard today HRSA and HCFA, to the extent that they will respond to an invitation to come to the table." FDA Center for Drug Evaluation and Research Director Peck emphasized the need for more comprehensive Phase I/II studies for AIDS therapies in concluding remarks at the close of the meeting. "With the shrinking opportunity to undertake rigorous investigation of AIDS drugs prior to wide distribution in less informative situations, I believe we need to significantly improve the information we gain in the Phase I and early Phase II trials," Peck said. Noting that Phase I studies typically document toxic effects and the maximum tolerable dose, Peck said that "we must expand on this considerably -- with dose response, both toxicity and efficacy. We need to take this precious limited opportunity we have to gather pharmacokinetic metabolism and pharmacodynamic data and [make] an effort to identify factors for individualizing and optimizing therapy." Peck commented that "while this may increase the rigors of participation in clinical trials and may increase the complexity of demands on designers and implementers of clinical trials, I believe that it is mandatory in order to insure derivation of information, to insure knowledge of effectiveness, and adequate instructions to physicians for optimizing therapy for their patients once the drug is fully available." Noting that not enough information was available with AZT for physicians to treat patients with the best dosing regimen, Peck said: "The concern here derives from the real prospect that doctors may prematurely become party to advising patients to stop a drug before it's optimized -- to stop a drug that's known to be effective and that could be effective for that patient -- in favor of an experimental drug of unknown efficacy." Peck pointed to the need for "collective responsibility" for the inevitable problem drugs that come out of the parallel track process. "We know from our experience with drugs in many, many areas, including AIDS, that most of the drugs proposed are not going to be effective, and every one of them will be toxic," Peck said. "In the treatments on the parallel track, almost surely, we'll get the dose wrong, the drug will ultimately prove to be ineffective, the drug will be too toxic, or patients that end up taking the drug will not be the patients that the drug will help." He added: "I'm hoping that we'll all be prepared and mature enough to take collective responsibility for that eventuality." * FDA had asked the committee to address a number of specific questions about the details of a parallel track system, such as the criteria for selecting drugs for expanded availability and the appropriate patient populations. Although the committee did not address the specific questions, the panel suggested that a good starting point for the new committee would be a set of guidelines endorsed by roughly 20 AIDS-related groups. The document recommends that drugs be made available after Phase I studies to six types of patient populations with AIDS or HIV-related diseases: ** people with a condition for which there is no standard treatment ** people who cannot tolerate the standard therapy ** people failing on a standard therapy ** people who must stay on concomitant medications excluded but "not expressly contraindicated," in trials of new experimental treatments ** people who live too far from the site of an appropriate controlled trial ** and people who are too sick to participate in an appropriate controlled trial. In addition to the six advisory committee members participating in the meeting, FDA called together a panel of roughly 30 non-voting consultants, including researchers, physicians, industry representatives and patient advocacy groups. The meeting was also attended by Young, Mason and NIAID Director Anthony Fauci, MD, who first publicly proposed the parallel track approach in June.
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