This setting lets you change the way you view articles. You can choose to have articles open in a dialog window, a new tab, or directly in the same window.
Open in Dialog
Open in New Tab
Open in same window

Journal of Economic Perspectives: Vol. 22 No. 1 (Winter 2008)

Expand

Quick Tools:

Print Article Summary
Export Citation
Sign up for Email Alerts Follow us on Twitter

Explore:

JEP - All Issues


Is the Food And Drug Administration Safe And Effective?

Article Citation

Philipson, Tomas J., and Eric Sun. 2008. "Is the Food And Drug Administration Safe And Effective?" Journal of Economic Perspectives, 22(1): 85-102.

DOI: 10.1257/jep.22.1.85

Abstract

In the United States, the Food and Drug Administration (FDA) provides public oversight of the safety and efficacy of drugs; medical devices; biologics like vaccines and blood products; cosmetics; radiation-emitting electronic products; veterinary products; and all foods, except meat and poultry (which are regulated by the Department of Agriculture). According to the FDA, the products it regulates account for more than one-fifth of U.S. consumer spending. In the area of medical products, the FDA is responsible for determining whether marketed products are both safe and effective before and after they have been marketed. In this paper, we will explore whether the policies of the agency itself are safe and effective. We stress two issues, one static and one dynamic. The static issue concerns the potential duplication inefficiency when product safety is protected not only by the FDA but also by the private sector through product liability law. Put another way, what is the rationale for using product liability and the FDA to regulate drug safety? While intuitively it may seem that two systems must be better than one in ensuring drug safety, each system comes with costs. We then turn to the dynamic issue, the speed-safety trade off, and consider the extent to which higher safety is achieved at a cost of later market entry of effective and even life-saving products. We assess the Prescription Drug User Fee Acts (PDUFAs), which increased the speed of the agency's regulatory process starting in 1992, although according to some, at the cost of reducing drug safety. We conclude by suggesting a research agenda for future work on the Food and Drug Administration.

Article Full-Text Access

Full-text Article (Complimentary)

Authors

Philipson, Tomas J.
Sun, Eric

Comments

View Comments on This Article (0) | Login to post a comment


Journal of Economic Perspectives


Quick Tools:

Sign up for Email Alerts

Follow us on Twitter

Subscription Information
(Institutional Administrator Access)

Explore:

JEP - All Issues

Virtual Field Journals


AEA Member Login:


AEAweb | AEA Journals | Contact Us