Cornell Law Review Volume 93 Issue 5

The Little Agency that Could (Act with Indifference to Constitutional and Statutory Strictures)

More than a century ago, Congress inaugurated federal regulation of foods and drugs. By today’s standards, the 1906 Act looked terribly anemic, running just five pages in length. Thirty years later, reacting to difficulties with enforcing the original statute (as tragically revealed by a series of fatalities caused by a product called Elixir sulfanilamide), Congress replaced it with the […]

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Dirty Dancing – The FDA Stumbles with the Chevron Two-Step: A Response to Professor Noah

Professor Lars Noah deserves much credit for exposing some of the myriad ways in which the Food and Drug Administration (FDA) has consistently sought to expand its authority through questionable, and perhaps in some cases abusive, legal practices. As Professor Noah observes, there are signs that the federal courts’ century-long honeymoon with the FDA may be ending —and perhaps the FDA never […]

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Losing Deference in the FDA’s Second Century: Judicial Review, Politics, and a Diminished Legacy of Expertise

The Food and Drug Administration (FDA), created by the Federal Food and Drugs Act of 1906, recently entered its second century. With this new century comes new challenges, including the ever-increasing risk that the Agency will no longer enjoy the deference historically given to its policy decisions. The judicial deference given to the Agency is […]

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The FDA and Deference Lost: A Self-Inflicted Would or the Product of a Wounded Agency? A Response to Professor O’Reilly

Professor James T. O’Reilly’s article Losing Deference in the FDA’s Second Century: Judicial Review, Politics, and a Diminished Legacy of Expertise is a sweeping critique of the decline of the Food and Drug Administration (FDA), which until recently was considered one of the world’s premier health and safety agencies. According to Professor O’Reilly, the FDA’s decline, resulting in what […]

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FDA Regulatory Compliance Reconsidered

Many observers consider the Food and Drug Administration (FDA) vital for the protection of consumer health and safety. One hundred years ago, Congress established the entity that would become the FDA and authorized it to regulate foods and drugs, critical responsibilities that the agency has long discharged carefully. Throughout the past century, the FDA’s regulatory power has expanded systematically, […]

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Great and Lesser Powers of Tort Reform: The Primary Jurisdiction Doctrine and State-Law Claims Concerning FDA-Approved Products

As the federal agency tasked with ensuring drug safety, the Food and Drug Administration (FDA) is the single most important regulator in the pharmaceutical field. Currently, a vigorous debate exists over whether it should be the only regulator. Critics of the tort system see products liability suits as an additional, pernicious source of regulation. They argue that juries should […]

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Drug Review “Behind the Curtain”: A Response to Professor Struve

The architecture of accident compensation does not mesh well with the architecture of regulatory product approval. Accident compensation, which occurs through public jury trials, is overtly adversarial and virtually transparent. In contrast, regulatory product approval, which occurs through specific negotiation between the product sponsor and the regulatory body, is cooperative and consciously opaque. Indeed, the content of regulatory negotiations remains […]

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Food, Drugs, and Droods: A Historical Consideration of Definitions and Categories in American Food and Drug Law

This Article explores the evolution and interaction of the legal and cultural categories “food” and “drug” from the late nineteenth century to the present. The federal statutory definitions of “food” and “drug” have always been ambiguous and plastic, providing the FDA with significant regulatory flexibility. Nevertheless, the agency is not necessarily free to interpret the definitions however it […]

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