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Cardozo Law Review

Abstract

The SEC and FDA are two of the nation's most prominent agencies, and both are charged with protecting the public. The agencies are children of tragedy and share similar creation stories. These kindred agencies are both burdened with daunting missions and myriad challenges in executing them. Both balance protecting an unsophisticated vulgus from uncertain risk against over-regulation of sophisticated intermediaries. Yet, they have charted very different paths in trying to accomplish their missions. From the beginning, the SEC eschewed merit-regulation in favor of disclosure. In contrast, the FDA, in its quest to protect us from unsafe and ineffective drugs, grew to become the most prominent merit-regulator. Along its journey, the FDA's reputation has been sullied by approving unsafe and ineffective drugs and ultimately not fulfilling its mission. Worse yet, the FDA regulations have unduly delayed access to beneficial drugs. This Article presents the case for an end to merit-regulation in the context of prescription drugs and proffers a proposal for the FDA to adopt a regulatory model more akin to the SEC. It briefly describes the history of the SEC and the FDA and the context in which their distinct regulatory paths were forged. Then, this Article presents an overview of the drug approval process and describes its numerous shortcomings. Next, using the SEC as a model, this Article presents a proposal for the FDA to shift its regulatory focus from merit-based regulation to disclosure-based regulation. The proposal seeks to reframe the FDA's focus to the areas in which it can be most effective while increasing the public's access to drugs.

Disciplines

Consumer Protection Law | Law

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