Emory Corporate Governance and Accountability Review

Volume 3Issue 2

The First Amendment: Not One Size Fits All

Caroline Poplin | 3 Emory Corp. Governance & Accountability Rev. 30 (2016)

Dr. Poplin examines two recent federal cases, Caronia v. FDA and FDA v. Amarin, in which courts held that the First Amendment protects pharmaceutical manufacturers who market their drugs off-label as long as the advertising is “truthful and non-misleading.” In so doing, these courts essentially overturned restrictions Congress imposed in 1962, after the thalidomide disaster. The drug at issue in Caronia is particularly dangerous—it is closely related to a date-rape drug, and was approved for a narrow indication. The defendant sales representative nonetheless said the drug was “very safe”, and recommended it for a variety of common diseases, including Parkinson’s and insomnia. Today, however, the medical community requires rigorous evidence to determine the truth of any proposition. Yet these courts found the manufacturers’ statements “truthful and non-misleading” without any evidence at all. Dr. Poplin concludes that decisions about drug advertising are best left to an independent expert agency, the FDA.

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A Failure of Remedies: The Case of Big Pharma (An Essay)

Paul J. Zwier, Reuben Guttman | 3 Emory Corp. Governance & Accountability Rev. 42 (2016)

Paul Zwier and Reuben Guttman examine the U.S. pharmaceutical industry and the harms imposed on individual patients and healthcare consumers—including private and government third party payers—from practices proscribed by Federal and State laws regulating marketing and pricing. This Essay focuses on the False Claims Act, which has become the government’s primary civil weapon against fraudulent and/or wrongful conduct. This Essay examines the market for pharmaceuticals, as well as, its profitability and risks. The authors evaluate the pricing of pharmaceuticals, the incentives in the market that seem to cause institutional behaviors that drive illegal conduct, and why faith in the free market fails in the case of pharmaceuticals. Zwier and Guttman discuss the failures of existing traditional remedies in the False Claims Act and the related actions to adequately compensate, deter, and punish for Big Pharma’s illegalities and propose a combination of remedies to address this.

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