Can We Get a Refund? Judicial Remedies for Drugs That Do Not Work

Publication Title

Tennessee Law Review

Document Type

Article

Publication Date

2024

Abstract

Congress created expedited pathways that speed approval of potentially lifesaving new drugs by requiring potentially less rigorous evidence that a drug works for a new indication prior to FDA approval. However, the 2021 controversial approval of a new Alzheimer's treatment, aducanumab, shined a spotlight on the increasing potential for the FDA to approve high-priced-minimally-effective drugs. These drugs inflict serious, difficult-to-measure harms on tens of thousands of patients and diffuse financial harms for payors and the public, cumulating in over tens of millions of dollars every year. The growing problem of high-cost drugs is well known, but this article explores a solution that prioritizes access to medications through restructuring state fraud laws to redress financial injuries to Medicaid programs from minimally-effective drugs after FDA approval. Currently, once a drug receives FDA approval, tort law and regulatory hurdles make it difficult to challenge a drug's efficacy in practice. Potential harms of high-priced-minimally-effective drugs can be amplified when patients and payors are left without judicial remedy. Rather than deny patients access to potentially lifesaving new drugs in contradiction to current regulations, this article explores an expansion of state fraud laws to discourage confirmatory trial delays and delayed withdrawals of minimally-effective medications. In short, rather than asking if we can afford to pay for the hope that a new drug will help Americans with life-threatening diseases, we should be asking for a refund.

Recommended Citation

Anjali D. Deshmukh, Can We Get a Refund? Judicial Remedies for Drugs That Do Not Work, 91 Tenn. L. Rev. 621 (2024).

Volume

91

First Page

621

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