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 nonphysiological 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-identified 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 for FDA intervention, ranging in intensity from 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.

Craig Konnoth, Drugs’ Other Side-Effects, 105 Iowa Law Review, 171–238 (2019).