Evaluating and Regulating Pharmacoeconomic Information in the Private Sector *

Abstract

As competitive pressures rise in the United States health care system, pharmaceutical companies are increasingly conducting and disseminating pharmacoeconomic studies to provide evidence that their products are cost-effective. The Food and Drug Administration's (FDA) Division of Drug Marketing Advertising, and Communications has released draft guidelines that would require pharmacoeconomic claims used in promotional materials to contain an appropriate level of scientific rigor and validity. A number of observers have criticized the inflexibility of the guidelines, and called for more independent evaluation of pharmacoeconomic claims in the private sector, with the FDA playing a more modest oversight role. But how feasible is such private review and what form would it take? Moreover, even if the market evolves mechanisms to evaluate pharmacoeconomic information, what role would the FDA play and by what principles should it abide? The paper explores these questions by considering how various public and private models for evaluating and providing information work in other sectors of the economy, and how the various models could apply to the review of pharmacoeconomic information.