Should Off-label Uses Be Under Informed Consent?

Research should be conducted on whether an off-label use of a medical product should be disclosed to patients under informed consent, according to University of Arizona law professor and faculty member of Harvard’s Petrie Flom Center for Health Care Policy, Bioethics and Biotechnology Christopher Robertson. In a recent blog posting, Robertson cited a recent national survey by Consumer Reports that found most Americans (94%) “say they have never been told by a physician that a medication they were taking was not approved by the FDA for their condition,” and 63% would not take a doctor-prescribed drug that was not approved for their specific condition.

Calculating off-label use prevalence, Robertson noted that in a 2006 review, about 21% of prescriptions filled were for off-label uses.  Another study found that 79% of patients discharged from pediatric hospitals were taking at least one product off-label. And a 2016 JAMA paper found that 30% of antidepressant prescriptions were prescribed off-label. “Legally, some have suggested that off-label status must be disclosed by physicians to secure informed consent,” he wrote. “My co-authors and I have argued that any fact that would cause a substantial number of patients to change their decision should be considered ‘material’ information that a physician must disclose.

“Until recently,” Robertson continued, “I was not aware of any court holding that off-label use must be disclosed. Times may be changing. Based on a few anecdotal cases I found, I am now beginning a systematic review of that case law, so please send along any instances — whether styled as informed consent claims or medical negligence. Before endorsing a broad duty to disclose, further research should explore whether patients over-react to such disclosures, or whether physicians can put them in appropriate context to increase the quality of decision-making overall. There are also larger system-effects at stake, as well: if physicians make such disclosures and patients become more scrutinizing, this may cause companies to more often invest in the clinical trials that will determine safety and efficacy. When companies succeed, they will thereby secure a new labeled indication, moving more uses on-label.”