WASHINGTON _ Two adversaries, bloodied and embittered,meet for the first time far from the battlefield and talk.It is a scenario straight from a B-movie, except for one detail _the stars don't have much Hollywood appeal. Still, it's not oftenthat the FDA and the industries it regulates meet, on neutralground, to discuss scientific issues of mutual concern.In fact, if the organizers are to be believed, it has never happenedbefore. "Why we didn't do it before is a question a lot of us havebeen asking," said Thomas Cairns, of the FDA's Office ofRegulatory Affairs.The FDA's two-day Forum on Regulatory Sciences, which endedFriday, brought together approximately 800 government scientists,academics and members of industry to discuss topics ranging from"Analytical Method Validation and System Suitability in thePharmaceutical Industry" to "Indices of Decomposition"; from"Neurotoxicity: A New Risk Frontier" to "Alternatives to AnimalTesting."If the lineup had a drawback, it was that it was heavily weightedwith government scientists and sparsely attended by theirentrepreneurial counterparts. "You start to walk before you canrun," Cairns said. He said the idea for the forum was broached at a discussion of theFDA's senior science council, made up of the leaders of each of theagency's centers and the Office of Regulatory Affairs. Elkan Blout,adviser to FDA Commissioner David Kessler, got the effort going,Cairns said.Kessler, in his introduction to the meeting, said the FDA's decisionto sponsor the symposium "reflects the agency's commitment to agrowing need to communicate with health professionals andscientists in the academic and industrial sectors."Leon E. Rosenberg, president of Bristol-Myers Squibb Co., in NewYork, told the meeting in his keynote address that as uncomfortableas it often is, "Somehow this remarkable triangle of science works.Why? Because each partner has understood its unique role andfulfilled its responsibilities."Government, Rosenberg said, "has understood that its part inscience is to be the principle catalyst of discovery _ and the majorfacilitator of the action. This means not just funding the effort, butseeing that the outcomes truly do benefit people."A century ago," he added, "before there was any gleam of afederal drug administration, hucksters were selling `Kick-a-pooSagwa' to cure cancer and `Warner's Safe Cure for Diabetes.'Ingredients were missing, warnings completely absent."Academia, Rosenberg said, has conducted "most of the researchthat has been the basis for so many of the medical advances in thiscentury."Industry, he said, is the place "where science goes to market, wherediscoveries are translated into realities . . . but we know that ourprinciple function is to develop and market products that meethuman and medical needs."Everette Beers, a scientific reviewer at the FDA's Center forDevices and Radiological Health, said, "It's not always possible forregulators, academia and industry to get together and talk."There are confidentiality issues and unfortunate adversarial issues_ at this meeting we're all scientists talking about common issuesand common goals."Eugene Rickard, senior research scientist for Eli Lilly & Co.,praised the event, but criticized the agenda, made up of standardscientific presentations, for stifling conversation rather thanencouraging it."The talks don't lead to much dialogue," he said. "It's a one-waytransfer of information. But it's a start." n
-- Steve Sternberg Special to BioWorld Today
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