WASHINGTON -- Next year the FDA will begin to acquire anexpertise in pharmacoeconomics, the agency's commissioner,David Kessler, said at the 37th Annual Conference of the Foodand Drug Law Institute this week.
In the past couple of years, FDA spokesman Jim O'Hara toldBioWorld, drug companies have begun to include cost-effectiveness claims in their advertising. FDA's role includesoversight of advertising claims "to ensure that they are basedon solid scientific data," Kessler said earlier this fall in a speechto pharmaceutical manufacturers in New Jersey.
Companies previously promoted drugs to doctors based onefficacy, but now "they're targeting large purchasers, HMOmanagers ... health-care administrators who are deciding whatproducts are included in the formulary on the basis of cost-effectiveness," Kessler said in his speech in the fall.
But cost-effectiveness studies usually lack the rigor andsophistication of clinical trials, he said. "We have seen, forexample, a company say that its product is more cost-effectivethan another in its class simply because it costs less, withoutany evidence that the two drugs actually have the sameeffectiveness profile," he said.
FDA's involvement is appropriate, said Kessler, because "moreand more, the therapies available to patients are going to bedetermined by decisions based on pharmacoeconomic data."But FDA has no plans to use cost-effectiveness data in the drugapproval process, O'Hara told BioWorld.
-- David Holzman Washington Editor
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