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Executive Summary

BRISTOL-MYERS SQUIBB's VIDEX (ddl) SCHEDULED FOR JULY ADVISORY COMMITTEE review, FDA Center for Drug Evaluation and Research Director Carl Peck told ACT UP in an April 18 letter. In the letter to David Barr of the Gay Men's Health Crisis, Peck said that FDA is "planning a meeting of the [Antiviral Drugs Advisory Committee] for early July" to review the Videx NDA. Peck's letter was in response to an April 5 letter from Barr, writing on behalf of ACT UP/New York's Treatment and Data Committee, that called for the Videx NDA to be reviewed in 30 days ("The Pink Sheet" April 15, p. 8). The AIDS activist group also argued against putting the drug through an advisory committee review. Bristol-Myers Squibb filed the NDA on April 2 ("The Pink Sheet" April 8, T&G-2). ACT UP threatened FDA with a May 6 protest if the Videx NDA was not reviewed within 30 days. Peck pointed out that "a sense of urgency has been central to our efforts to expedite the development of ddl and to assist Bristol-Myers Squibb in submitting their NDA." Videx has pioneered new territory as the first drug to treat AIDS to proceed to an NDA submission through FDA's reformed approval process. The drug's clinical development program has served as the prototype for HHS' expanded access program. Videx is the second antiretroviral to reach NDA submission through FDA's accelerated approval framework for drugs for AIDS and other life- threatening illnesses. Unlike the AZT approval, which was based on placebo-controlled trials and mortality as an endpoint, Videx efficacy will be based on surrogate endpoints, such as CD4 levels, and historical controls. In his letter to ACT UP, Peck touched on the importance FDA is placing on an advisory committee review given the precedent- setting nature of the Videx NDA. Peck said FDA regards holding an advisory committee meeting "to be essential for public discussion and advice on such issues as the use of historical controls and surrogate markers in determining the safety and efficacy of ddI." The FDA official added that FDA has "conducted an intensive pre-NDA data analysis, established the surrogate markers task force, and involved in the process outside experts such as the members of the Antiviral Drug Products Advisory Committee and the staff of the National Institutes of Health." When the Videx NDA was received, Peck said, "we intensified our ongoing review." FDA and the Antiviral Drugs Advisory Committee have already begun laying the ground-work for the Videx NDA review session, including a February 13 advisory committee meeting on AIDS surrogate endpoints. At that meeting, the panel reached a consensus that CD4 was an acceptable primary endpoint but not a complete surrogate marker. In anticipation of approving Videx on the basis of surrogate endpoints, FDA has formed two internal task groups: one to look at the policy questions surrounding an approval based on surrogate markers; and a second group to look into the idea of "conditional approvals" that would require post- marketing studies by the drug's sponsor. As to ACT UP's plans for a demonstration, Peck stated: "I believe that the threat of a demonstration on May 6 does not serve the interests of people with HIV infection. At best, a protest would detract from the spirit of cooperation among government, industry and the activist community representatives that is vital for the expeditious development and marketing of new therapies for AIDS." Peck added that the demonstration "could succeed in diverting our staff from pursuing important review tasks, thereby jeopardizing early access to this drug for the very people you represent."

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