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Executive Summary

REVISING DRUG APPROVAL PROCESS TO INCLUDE "MORE FLEXIBLE CRITERIA" is among changes suggested by T Cell Sciences Chairman and CEO James Grant at a May 10 Alex. Brown health care seminar in Blatimore. Grant, a member of the FDA "blue ribbon" committee, said one answer to improving drug review "is to start work towards more flexible criteria and different criteria for different diseases. Benefit/risk ratios will be different in terminal diseases versus long-term therapy versus diseases which are annoying but not debilitating." Grant, an FDA deputy commissioner during the Nixon Administration, commented that "we have a situation today where science, medicine and technology have overtaken our ability to establish rules. The traditional approaches are not quite so clear when one looks at modern medicine in drug therapy." He added: "My problem with the FDA actions in the past is that when you fundamentally look at their efforts to improve the drug approval process, they have tried to do the same thing they have always been doing, only faster. I have news for you: that won't work. It really will not." The blue ribbon commission, recently convened by HHS Secretary Sullivan to evaluate how to strengthen FDA, will hold its first formal meeting May 17-18. The group is chaired by former FDA Commissioner and current Scripps Clinic President Charles Edwards ("The Pink Sheet" March 26, p. 9). Grant also noted the existence of "another unique opportunity to improve the effectiveness and efficiency of drug approval." Universities are making an effort to limit monetary rewards of drug marketing to medical researchers, he commented. "Given this self-regulation, I would advocate a greater medical community involvement in the design and conduct of clinical trials and in the approval process." This "is one way to bring the best scientific and medical brains in America to bear on the problem," Grant suggested. "It is another way to give FDA access to more skilled people." He pointed out that "the changes I mentioned, though, may well require legislative remedies. They may not be within the purview of FDA." Addressing the issue of agency resources, Grant insisted that FDA "will never have enough resources to do what society is asking it to do." Estimating that "the last budget that I had when I was at FDA in constant dollars is essentially the current FDA budget," he noted that "there are fewer inspectors now than there were over a decade ago, and, when you look at all of the legislative mandates that have been added to FDA over the last two decades, you realize they do not have enough resources for this job." However, Grant remarked that "'blue ribbon' committees do not raise agency budgets," but rather, funding increases "when the agency has the statute and the status to negotiate effectively with the Office of Management and Budget, and when it has the stature and status to get support on [Capitol] Hill." He urged the pharmaceutical industry "to stop paying lip service" to the idea of "let's raise FDA's budget," and instead "really find ways to enhance the stature and status of the agency."

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