FDA Center Emphasizes Research

WASHINGTON—Ask Carl C. Peck of the Food and Drug Administration how important research is to his job, and he’ll simply point to the title of the center he heads. Peck is the first director of the FDA’s new Center for Drug Evaluation and Research. He said he has an “upfront agreement” with FDA Commissioner Frank E. Young to “bring research and training to a new level of legitimacy in this agency.” The result, he said, will be ‘an emphasis on scientific research that “really hasn’t been there for a long time, if ever.” Peck’s approach won't mean that researchers will carry out research in isolation from regulators. “The type of process I want to promote is to get the reviewers, when they’re faced with a problem, to the point where they’ll ask the researchers about ways in which that problem might be tackled.“In an agency that regulates drugs where the development, the manufacturing processes and their applications all involve scientific principles,” he said, “it is virtually a given that the reviewers in that agency ought to be knowledgeable about the underlying science. In recent years several FDA commissioners have tried to combine research with drug regulation. In 1982 Arthur Hull Hayes combined the bureaus of biologics and of drugs into the Center for Drugs and Biologics. The Bureau of Biologics had a long tradition of research as part of its regulatory activities, and Hayes hoped that the Bureau of Drugs would benefit from the association and that drug regulation would be put on a scientifically rational basis.In announcing the reorganization in the Federal Register, Health and Human Services Secretary Otis Bowen said that two programs within the FDA—the search for more effective AIDS diagnostics tests and an AIDS vaccine, and the process of approving new drugs—had become too important to be handled by the same office. Splitting the functions, he said, will provide “more focused leadership on a day-to-day basis and better management of resources.” Both Peck and Paul Parkman, head of the new Center for Biologics Evaluation and Research, will report to Young.Peck, 45, came to FDA in October from the Uniformed Services University of the Health Sciences (USHUS) in Bethesda, Md., where he had been professor of medicine and pharmacology. A physician by training, he has a particular interest in pharmacokinetics and transdermal drug delivery systems. Peck takes a broad view of potential areas of research for the Drug Center, but acknowledges that some issues—such as methods of bioavailabiity testing—are of special interest. Another area is the regulatory process itself.“What does it cost us to do a review?” he asked. “Are there ways that it can be improved?”The center may also study the new investigational drug applications (INDs), particularly those from small, less well-financed sponsors. “Some sponsors are better than others at gathering information on drug absorption, distribution, metabolism and elimination, so they are far along when it comes to the Phase II clinical studies,” Peck said. “So we are thinking about cooperating with some sponsors, helping them to gather the data to get their clinical studies started sooner.”But he cautions that “we have to make sure that this happens in a way that doesn’t impair the ap proval process and, in the long run, improves it. So it’s got to be done slowly and gently.”Next year’s FDA budget request now before Congress includes several million dollars to fund a number of university-linked training programs, Peck said. Under the program, FDA would partially fund a faculty position.“Because we would pay a substantial part of this person’s salary he or she would also be a consultant to FDA, perhaps doing reviews or maybe serving as an advisory committee member,” Peck said. “The programs would also include one or two research fellows.” Initially the programs would be used mainly to train medical officers in clinical pharmacology, with the goal of having the best of them spend some time working at FDA.The first of these efforts is likely to be a link with the training program Peck maintains at USHUS, where he spends half a day each week working with a graduate student and two research fellows.Peck admitted he has few additional resources to work with. Except for the 10 to 20 new positions made possible by AIDS funding for FDA, “we will have to make do with what we already have in place,” he said. He hopes to begin by “inspiring some redirection within the available research resources.“This is not an overnight effort,” he warned. “I expect to be here to make a three- to five-year impact. What we’re able to initiate in the first year will be extended into the second year and so on. What I’m describing here is really a vision of the future.”Marwick covers the FDA for the Journal of the American Medical Association.

FDA Center Emphasizes Research

Ask Carl C. Peck of the Food and Drug Administration how important research is to his job, and he’ll simply point to the title of the center he heads.

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