Evaluating and Regulating Pharmacoeconomic Information in the Private Sector
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EVALUATING AND REGULATING PHARMACOECONOMIC INFORMATION IN THE PRIVATE SECTOR* PETER J. NEUMANN, ScD Assistant Professor of Policy and Decision Sciences, Harvard School of Public Health, Boston, Massachusetts
DARRENE. ZINNER,MS Associate, Covance Health Economics and Outcomes Services Inc., Washington, District of Columbia
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 validiv. A number of observers have criticized the inflexibility of the guidelines, and called for more independent evaluation of pharmacoeconomic claims in the private sectoc 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. Key Words: Cost-effectiveness analysis; Pharmacoeconomics
INTRODUCTION IN THE SPRING OF 1995, the Food and Drug Administration’s Division of Drug Marketing Advertising, and Communications released draft guidelines that would require that pharmacoeconomic (PE) claims used in
Presented at the DIA Workshop “Cost-Effectiveness Analysis: Measures and Methods in Clinical Trials, November 14-15, 1996, New Orleans, Louisiana. Reprint address: Peter J. Neumann. ScD. Assistant Professor of Policy and Decision Sciences, Harvard School of Public Health, 718 Huntington Ave., Boston, MA 021 15. *Research support provided by HoffmannLaRouche, Inc. The views expressed are solely those of the authors.
promotional materials contain an appropriate level of scientific rigor and validity. Since their release, the draft guidelines have been the subject of debate, and the topic of an FDA hearing (1). A number of observers have criticized the guidelines and called for more independent evaluation of pharmacoeconomic claims in the private sector, with the FDA playing a more modest oversight role (2.3). Some evidence suggests that managed care decision makers themselves would prefer independent evaluation of claims, rather than rigid FDA standards (4). 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
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