Shivani Aggarwal
University of Cambridge
Off-label prescription practices are a pervasive, often overlooked, and frequently misunderstood peculiarity of the present-day medical system. I articulate two dilemmas presented by this practice – when is it justifiable for a physician to prescribe off-label, and whether a physician should disclose that a prescription is off-label. By interrogating the construct of patient trust in doctors and concluding that an institution-based model of trust is a better descriptive account, I offer a perspective on what is fundamentally “sticky” or troubling about off-label prescriptions as well as a way to re-orient discussions around each of the two dilemmas.
In contexts such as drug prescription decisions for which harms are not definite but risk-based, assigning evidence-based probabilities to different risks, can enable physicians to assess whether a commitment to non-maleficence has been met. What kinds of evidence would in theory indicate that an off-label prescription is epistemically-justified, such that physician obligations to avoid negligent behavior are satisfied? Subsequently, for physicians to best respect the autonomy of patients when prescribing off-label, what information should be provided to a patient as part of the informed consent process?
I conclude that negotiating the trade-offs between beneficence and non-maleficence necessitates active engagement with available evidence to understand if there are reliable signals of efficacy. I suggest that space for the individual judgement of doctors may be reconciled with an institution-based model of trust through measures that bureaucratize such judgement. Given the norms that govern effective communicative transactions, I argue that off-label regulatory status should be disclosed by physicians.
Ultimately, off-label prescription practices will likely continue to figure prominently in the practice of medicine, with substantive implications for the health of patients seeking treatment options.
Chair: Dominik Boll
Time: September 11th, 18:20 – 18:50
Location: SR 1.007 (online)
SOPhiA 2026 