Teaching the Elephant to Dance: Privatizing the FDA Review Process

November 1996

Issue: 51 Food and Drug law Journal 651-676 (1996)

The Food and Drug Administration (FDA) recently came under a criticism that it acts too slowly in reviewing new product applications, imposes needless and costly regulation, and engages in abusive practices against regulated entities that criticize or challenge its decisions. The resulting harm, according to the critics, is a loss of beneficial or even life-saving products for U.S. consumers and a loss of U.S. jobs to foreign shores. The critics have found a sympathetic ear in a Republican Congress that has launched a movement against the FDA, demanding comprehensive reform of the way the agency does business. Perhaps the most controversial aspect of the proposed reforms is whether (or to what extent) the FDA’s review function should be "privatized," i.e., whether the FDA’s current monopoly as the sole reviewer of the safety and efficacy of drugs, food additives, and medical devices should be broken. This article explores the privatization concept in-depth, discussing such topics as: what is the genesis of the privatization movement? What does the term "privatization" mean? What legislative and regulatory privatization proposals have been put forth thus far? What entities could compete with the FDA? How would consumers be affected? How could conflicts of interest be minimized? The article concludes that privatization of the FDA’s review function is normatively desirable. Specifically, because the current system of product review often results in excessive causation and regulation, breaking the FDA’s review monopoly could eliminate or change this situation, speeding review and enhancing regulatory efficiency. Providing statutory standards of safety and efficacy are unaltered and the FDA retains veto authority over any private reviewer’s decision, breaking the FDA monopoly holds the greatest long-term promise to "teach the elephant to dance" without compromising consumer safety.


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