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105 Iowa L. Rev. 171 (2019-2020)
Drugs' Other Side-Effects

handle is hein.journals/ilr105 and id is 181 raw text is: Drugs' Other Side-Effects Craigj Konnoth* ABSTRACT: Drugs often induce unintended, adverse physiological reactions in those that take them-what we commonly refer to as side-effects. However, drugs can produce other, broader, unintended, even non- physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identifzed African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (FDA) has broad discretion under the Food, Drugs, and Cosmetics Act (FDCA ) to regulate drugs, it generally considers only traditional side-effects. Neither the agency, courts, nor scholars have offered a systematic account of how to regulate collateral effects that do not involve direct physiological harm to the drug's recipient. This Article more clearly defines these harms and explains why and how the FDA should take them into account. It starts by offering three characteristics that distinguish these harms from those the FDA traditionally considers. First, unlike traditional harms, these harms are often the indirect rather than direct result of drug consumption. Second, they often affect third parties rather than the person that ingests the drug. Third, they might often raise non-health considerations, such as economic or moral concerns. Both ethically and legally, the FDA should take into account such indirect, third-party, and non-health harms to some degree at least. Bioethical considerations, administrative accountability and practice, as well as pragmatic policy interests, all counsel considering these harms. But how should the FDA do so? As the Article explains, the FDCA offers a variety of choices forFDA intervention, ranging in intensityfrom flat approval refusals to mandating labeling or prescription guidelines. In most cases, various considerations suggest that more limited forms of intervention are usually appropriate to address these harms. * Associate Professor of Law, University of Colorado School of Law. My thanks to Patti Zettler, Hank Greeley, Lewis Grossman, and Pierre Schlag for helpful conversations and detailed comments. My thanks also to participants of the Colorado Law Works in Progress Workshop, the Stanford Law Biolawpalooza, the Health Law Professors Conference, the Mid-Atlantic Health Law Conference, and the Duke Culp Colloquium.

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