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Executive Summary

The parallel track regulations will be broadened to include drugs for serious and life-threatening illnesses other than AIDS and HIV-related diseases once FDA has experience with the program and is assured that parallel track will not interfere with ongoing controlled clinical trials, FDA Commissioner Kessler said at an April 9 press conference to announce implementation of drug approval process reforms. In response to a question as to why the parallel track regs are being limited only to drugs for AIDS and AIDS-related diseases, Kessler said: "Our intent is to expand parallel track to all serious and life-threatening diseases after we've had some experience. The intent is to start with AIDS to make sure that we learn how do it." Kessler pointed out that "there are some important issues that we need to confront. For example, we don't want to impede ongoing clinical trials." He added that "we don't want to end up speeding up the process and in the end not get the data that we need, because in the end there's a risk that we'll slow it down." A background document on the forthcoming regs says that "the Public Health Service is also prepared to work with interested patient groups, physicians and sponsors to develop comparable programs for other life-threatening diseases when there is significant support for doing so." The parallel track reg will be published April 15. The policy, proposed in May 1990 to provide access to investigational AIDS drugs to patients who have no alternative therapy and cannot participate in controlled trials, has been languishing at the Office of Management and Budget for over a year. FDA has had experience with expanded access programs for AIDS, including the Treatment IND and open-label program for Bristol- Myers Squibb's Videx (ddI), which was approved in October. In the future, the agency will have information about Hoffmann-La Roche's large simple trial and open-label program for the AIDS agent Hivid (ddC) ("The Pink Sheet" Feb. 24, T&G-7). The NDA for Hivid is going before the FDA's Antiviral Drugs Advisory Committee on April 20-21. The firm is seeking approval for Hivid in combination with Burroughs Wellcome's Retrovir (AZT) in AIDS patients with CD4 cell counts of less than 200 and as a treatment for patients intolerant to AZT. At a recent hearing before Rep. Waxman's (D-Calif.) House Energy & Commerce/Health subcommittee, Rep. Studds (D-Mass.) asked Center for Drug Evaluation and Research Director Carl Peck, MD, to provide an update on the efficacy of treating AIDS with the combination therapy of ddC and AZT. Peck replied: "I can tell you that interesting data will be presented" on the combination during the advisory committee meeting. He added: "You are probably already aware that there are published accounts that show in a small number of patients that this is a promising combination." Roche has combination use data on 56 patients. Studds said he understood "that ddC on its own does not look particularly promising...but that in combination with AZT it shows some promise." Roche discontinued a comparison study of ddC and AZT in January because a one-year interim analysis showed that survival was greater in the AZT arm ("The Pink Sheet" Jan. 13, T&G-3). The congressman asked whether FDA procedures are "flexible enough" to approve "a drug in combination as opposed to on its own." Peck responded: "I think the simple answer is 'yes.' We have often approved drugs in combination in the past." The May 1990 proposed parallel track policy contained several safeguards to ensure that parallel track procedures will not adversely affect controlled trials, including placing an expanded access study on clinical hold and requiring sponsors to set up a Data and Safety Monitoring Board or its equivalent to monitor the controlled trials for enrollment problems ("The Pink Sheet" May 21, 1990, p. 8). Asked at the press briefing why FDA will not test the parallel track system with drugs for Alzheimer's disease, Kessler replied that "there are a series of tools available to speed up drugs. One that's already on the books is a Treatment IND that does apply to Alzheimer's disease." Warner-Lambert currently has a Treatment IND for its Alzheimer's drug Cognex (tacrine). The commissioner was also asked whether companies can charge for their drugs under a parallel track program. "There are... existing investigational drug regulations [that] do permit them to recover their cost," Kessler said. "Most however, choose not to charge during investigational stages." Kessler was asked whether one catch to the program is that companies must take the initiative to enter their drugs into parallel track. The commissioner responded: "We have a role; we're not just going to sit back; we're not just going to wait for the manufacturer to decide." Kessler pointed out that FDA had asked Roche to make Hivid available under an open access program to AIDS patients following the agency's discovery that underground ddC, made available from buyers' clubs, was subpotent or superpotent and FDA's request that the clubs stop selling it. Roche announced its open-label program on Feb. 20, but the first shipment of Hivid, to four physicians treating 200 patients, did not go out until April 10. Roche said the delay in shipments was due to time needed for physicians to complete paperwork required for enrollment in the program. Paperwork from 43 other physicians is being evaluated. PWA Health Group Executive Director Derek Hodel said buyer's clubs have received constant complaints about the unavailability of Hivid. He added that clubs will probably start selling unapproved but properly made ddC, if the company fails to meet the supply demand.

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