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.
Similar content being viewed by others
References
Food and Drug Administration. Pharmaceutical Marketing and Information Exchange in Managed Care Environments. Public Hearing. Silver Spring, MD, October 19, 1995.
Neumann PJ. Zinner DE, Paltiel AD. The FDA’s regulation of cost-effectiveness claims. Health Aff. 1996;3:54–71.
Calfee JE. Regulatory issues in cost-effectiveness claims. In Calfee JE (Ed). Policy issues in pharmaceutical cost-effectiveness research. Washington, DC: American Enterprise Institute; 1998.
Luce BR. Lyles AC, Rentz AM. The view from managed care pharmacy. Health Aff. 1996;4:168–176.
Rose J. Regulating cost effectiveness claims. Presentation at Food and Drug Administration Conference, “Comparing Treatments: Safety, Effectiveness and Cost-Effectiveness,” Bethesda, MD, March 24, 1995.
Bureau of Economics and Consumer Protection of the Federal Trade Commission. In the matter of pharmaceutical marketing and information exchange in managed care environments: Public hearings. Docket No. 95N-0228, Washington, DC. January 16, 1995:15.
Best A. Controlling false advertising: A comparative study of public regulation, industry self-policing, and private litigation. Georgia Law Rev. 1985;20(1).
Taylor R. Director of Public Affairs, Motion Picture Association of America. Personal Communication, January 25, 1996.
Gold M. Siegel J, Russell L, et al. Cost-effectiveness in health and medicine: Report of the panel on cost-effectiveness in health and medicine. New York: Oxford University Press; 1996.
Weinstein MC. Siegel JE, Gold MR, et al. Recommendations of the panel on cost-effectiveness in health and medicine. JAMA. 1996;276:1253–1258.
Pharmaceutical Research and Manufacturers of America (PhRMA). Methodological and conduct principles for pharmacoeconomic research. Washington, DC: PhRMA; January 1995.
Task Force on Principles for Economic Analysis of Health Care Technology. Economic analysis of health care technology: A report on principles. Ann Int Med. 1995;123(1):61–70.
Hemenway D. Prices & choices: Microeconomic vignettes. Lanham, MD: University Press of America; 1985.
Heidt R. Industry self regulation and the useless concept, ‘group boycott’. Vanderbilt Law Rev. November 1986.
Udvarhelyi IS. Colditz GA, Rai A, et al. Cost-effectiveness and cost-benefit analyses in the medical literature. Ann Int Med. 1992;116(3):238–244.
Bradley C. Iskedjian M, Lonctot K, et al. Quality assessment of economic evaluations in selected pharmacy, medical, and health economics journals. Ann Pharmacother. 1995;29:681–689.
Neumann PJ. Zinner DE, Wright JC. Are methods for estimating QALYs in cost-effectiveness analyses improving? Med Dec Making. 1997;17:402–408.
Lax J. Moench E. Pharmacoeconomics and managed care: Understanding the issues, concerns, and the environment. Presented at the Food and Drug Administration public hearing, “Pharmaceutical Marketing and Information Exchange in Managed Care Environments,” October 19, 1995.
Zellmer W. “Comments of the American Society of Health Systems Pharmacists.” Presented at the Food and Drug Administration public hearing, “Pharmaceutical Marketing and Information Exchange in Managed Care Environments,” October 19, 1995.
Calfee J. Some economic aspects of cost-effectiveness research and its dissemination in the health care market. Public Comments to FDA. Washington, DC: American Enterprise Institute; January 1996.
Beales J. FDA regulation of pharmaceutical advertising: Economic analysis and the regulation of pharmaceutical advertising. Seton Hall Law Rev. 1994; 24:1370.
Author information
Authors and Affiliations
Additional information
Presented at the DIA Workshop “Cost-Effectiveness Analysis: Measures and Methods in Clinical Trials, November 14-15, 1996, New Orleans, Louisiana.
Research support provided by Hoffmann-LaRouche, Inc. The views expressed are solely those of the authors.
Rights and permissions
About this article
Cite this article
Neumann, P.J., Zinner, D.E. Evaluating and Regulating Pharmacoeconomic Information in the Private Sector. Ther Innov Regul Sci 32, 525–532 (1998). https://doi.org/10.1177/009286159803200224
Published:
Issue Date:
DOI: https://doi.org/10.1177/009286159803200224