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Document Type

Article

Publication Date

Summer 2019

Publication Citation

94 Indiana Law Journal 773 (2019)

Abstract

Is more information always better? First Amendment commercial speech jurisprudence takes this as a given. However, when information is only available from a self-interested and marketing-savvy pharmaceutical company, more information may simply lead to more misinformation. Notably, doctors are also misled. This can result in public health harms when companies are promoting unapproved uses of prescription drugs that the Food and Drug Administration (FDA) has approved for other purposes—commonly referred to as “off-label” uses. Contrary to judicial presumptions, as well as the presumptions of some doctors and scholars, doctors are not sophisticated enough to always discern what is true versus misleading information. Doctors are susceptible to the same largely unconscious cognitive biases as all individuals; this means that they operate on “schemas” (mental presumptions) that impact how they interpret marketing information. Courts also rely on schemas about how doctors interact with marketing. These schemas have contributed to a First Amendment jurisprudence that has serious consequences for public health because it fails to account for how doctors actually interact with marketing of off-label uses, and such uses are associated with adverse health consequences.

This Article argues that pharmaceutical marketing, especially regarding “offlabel” uses, should be more critically evaluated and entitled to less First Amendment protection—contrary to recent court trends, beginning with the 2011 Supreme Court case Sorrell v. IMS Health Inc. In other words, this Article is taking a new approach to address court cases that a number of scholars have criticized as unduly expanding the scope of First Amendment protection for pharmaceutical marketing with negative policy repercussions for public health. Not only are many off-label uses medically unsupported, but permitting broader promotion of such uses undermines incentives for companies to scientifically study those uses. Whereas prior articles have tended to focus on how to adapt to the new law or advocate rejecting the existing law based primarily on policy grounds, this Article uses cognitive bias literature to explain why recent cases actually fail to achieve key First Amendment goals. This Article further provides an empirically supported argument against expansion of First Amendment law for off-label promotion.

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