FDA and the Rise of the Empowered Consumer
Lewis A. Grossman
American University - Washington College of Law
May 2, 2013
American University, WCL Research Paper Series
Harvard Law School, Petrie-Flom Center Annual Conference, May 3, 2013
This paper traces the historical evolution of a view of consumers as informed, rational, and rights-bearing decision makers, and the corresponding diminution of FDA’s role as a paternalistic gatekeeper acting in conjunction with medical and scientific experts to prevent products and information from reaching the public.
The relationship between consumers and FDA-regulated products has changed dramatically since the mid-1960s. A half century ago, FDA treated consumers as passive and ignorant. Accordingly, the agency gave them relatively little latitude to make their own choices among products and denied them much of the information they could have used to inform such choices. By comparison, today’s consumers of food and drugs are much more empowered to make their own, unmediated choices among a wider variety of products, guided by a deluge of labeling and advertising information.
The paper examines this phenomenon against a background of three societal and cultural trends during the past half century: Americans’ declining trust in major institutions, the “rights revolution,” and the dramatic expansion of health care information accessible to consumers. It then examines a variety of specific regulatory developments during this period of change. In a section on food, the paper considers reforms in 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 paper 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 birth of social movements seeking to influence FDA drug approval policy. The paper concludes by speculating on whether this new model of consumer is a permanent one.
Number of Pages in PDF File: 49
Keywords: FDA, consumer, food, drug, prescription, labeling, advertising, over-the-counter, saccharin, vitamins, Laetrile, AIDSworking papers series
Date posted: May 28, 2013 ; Last revised: May 29, 2013
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