FDA Considers Its Role In Pharmacoeconomics

2 April 1995

While the US Food and Drug Administration has no statutory mandate to interpret pharmacoeconomic studies conducted by drugmakers on behalf of their products, in its regulatory role it must ensure that comparative studies make claims that are clearly and definitively proven and justifiable, according to Janet Woodcock, director of the FDA Center for Drug Evaluation and Research.

Only the FDA, of all the practitioners of this "relatively new and evolving discipline," must get to grips immediately with what are the standards in advertising containing PE claims, she said. It will be most concerned with the medical outcomes which are put into models for these studies and the establishment of standards in this area, and with establishing parameters for the dissemination of this information.

PE Draft Published "To Gain Feedback" Meantime, the FDA's Division of Drug Marketing, Advertising and Communication has published its proposals for enumerating the principles which it will use when reviewing PE claims in promotional materials. The Division stresses that the purpose of the draft is to obtain feedback on the issue; it does not represent FDA policy or guidance. Moreover, the Division adds: "these principles are not intended to apply to the conduct, analysis or reporting of those PE studies intended to serve as a basis for scientific exchange; several other documents have been advanced to guide the development and accurate reporting of such PE evaluations."

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