Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima) – Colombia.


The Role of the United States Federal Food and Drug Administration: Regulator, Watchdog, Facilitator or All of These?

Roseann B. Termini. Widener University – School of Law
Anthony Knabb DiDonato. Widener University – School of Law

June 26, 2013

Food and Drug Policy Forum, Vol. 3, No. 11, 2013


What would transpire if the United States Federal Food and Drug Administration (FDA) did not exist? The mission of the FDA is the promotion of the public health through prompt and efficient review of clinical research, and the taking of appropriate action on the marketing of regulated products in a timely manner. But, is the FDA a regulating agency? Is the FDA a watchdog agency? Or is the FDA a facilitating agency? The simplest and most obvious answer is that the FDA functions as all three. The relationship between the multi-functional role of the FDA and how to ensure that drug companies will comply with the agency provides the basis for this article.

Drug manufacturers have motivation to produce safe and efficacious products – market reputation and profit. In other words, it is in the best interest of drug manufacturers to self-regulate because without safe and effective products, drug firms would self-destruct. So why does the FDA find it necessary to implement stringent approval processes and postmarket drug surveillance? History strongly suggests that although most companies would undertake appropriate precautions to ensure public safety, quackery and negligence can never be fully eradicated, thus justifying regulation and a strong regulatory body to promulgate laws.

The expanse of FDA regulation is all-encompassing. That is, FDA regulatory authority extends to numerous products such as foods, human and veterinary drugs, medical devices, cosmetics, dietary supplements, biologics, and tobacco. However, this article will focus on pharmaceutical regulation to explore the interplay between FDA and the regulated industry. First, an historical overview will provide the origin for the need, foundation, and development of regulation geared towards drug law regulation as it exists in the United States today. Second, the FDA will be analyzed based on its functions as regulator, watchdog, and facilitator. Each of the three sections will address the ultimate question posed of how the FDA can ensure that drug companies will comply with regulations, and further draw conclusions as to whether the pharmaceutical industry could, or would, self-regulate so as to comply with Congressional mandates in the absence of the FDA.

A look back at history, case law, and the expansive reach of the FDA strongly suggests that while many, if not most drug companies, would comply or attempt to comply with federal law to ensure public health, a climate without a strong administrative agency to oversee the pharmaceutical industry cannot be justified.

Number of Pages in PDF File: 25

Keywords: food and drug law, FDA, Food and Drug Administration, administrative law, public health, pharmaceutical industry

Texto completo disponible en el siguiente enlace:

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