Abstract

http://ssrn.com/abstract=2271141
 


 



FDA and the Rise of the Empowered Consumer


Lewis A. Grossman


American University - Washington College of Law

May 2, 2013

Harvard Law School, Petrie-Flom Center Annual Conference, May 3, 2013
Administrative Law Review, Vol. 66, 2014
American University, WCL Research Paper Series 2014-21

Abstract:     
This Article traces the still-evolving view of consumers of FDA-regulated products as capable, rational, and rights-bearing decision makers. It also examines the corresponding diminution of FDA’s role as a paternalistic gatekeeper collaborating with medical and scientific experts to prevent products and manufacturer-provided information from reaching the public. Compared with their 1960s counterparts, today’s consumers of food and drugs have far greater freedom to make unmediated choices among a wider variety of products, guided by a relative deluge of labeling and advertising information. Moreover, food and drug regulation, once the exclusive domain of bureaucrats and experts, has become a focus of successful social movement activism.

The Article explores these phenomena against a background of three societal and cultural trends during the past five decades: Americans’ declining trust in major institutions, the “rights revolution,” and the dramatic expansion of health care information accessible to consumers. It then analyzes a variety of specific regulatory developments during this period of change. In its discussion of food, the paper considers the evolution of standards of identity and nutrition labeling, the rise of health claims as facilitated by the First Amendment, and various popular movements for freedom of choice with respect to food ingredients and dietary supplements. The Article then turns to drug regulation, examining the rise of patient labeling and direct-to-consumer advertising of prescription drugs, the tidal wave of “switches” from prescription to over-the-counter status, and the development of social movements intended to shape FDA drug approval policy. The Article concludes by speculating on whether this new model of consumer is a permanent one and by considering the implications of this question for FDA regulation in the future.

Number of Pages in PDF File: 50

Keywords: FDA, consumer, food, drug, prescription, labeling, advertising, over-the-counter, saccharin, vitamins, Laetrile, AIDS

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Date posted: May 28, 2013 ; Last revised: June 13, 2014

Suggested Citation

Grossman, Lewis A., FDA and the Rise of the Empowered Consumer (May 2, 2013). Harvard Law School, Petrie-Flom Center Annual Conference, May 3, 2013 ; Administrative Law Review, Vol. 66, 2014; American University, WCL Research Paper Series 2014-21. Available at SSRN: http://ssrn.com/abstract=2271141 or http://dx.doi.org/10.2139/ssrn.2271141

Contact Information

Lewis A. Grossman (Contact Author)
American University - Washington College of Law ( email )
4801 Massachusetts Avenue N.W.
Washington, DC 20016
United States
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