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Duquesne Law Review

Erin McCluan

Abstract

In March 2020, BuzzFeed News reported that a 45-year-old patient with systemic lupus erythematosus ("SLE") was denied her long-standing hydroxychloroquine ("HCQ") prescription due to the COVID-19 pandemic.1 Her healthcare network, Kaiser Permanente, informed her that this was necessary to "conserve[] the current supply for those who are critically ill with COVID-19."2 Disturbingly, Kaiser wrote to the patient, "Thank you for the sacrifice you will be making for the sake of those that are critically ill; your sacrifice may actually save lives." 3

The patient, Dale, who asked only to be identified by her first name, told BuzzFeed News, "I never agreed to sacrifice my health and possibly my life and cannot believe that I am being forced to do so."4 She expressed her fear that she is already immunocompromised and that not taking HCQ could result in a lupus flare, increasing her risk of developing serious COVID-related complications.5

HCQ is a disease-modifying anti-rheumatic drug ("DMARD") that has been used for decades to treat various otherwise-uncontrollable autoimmune diseases. 6 However, in early March 2020, this once little-known pharmaceutical became a household name after President Donald Trump touted HCQ as a potential "miracle" cure for COVID-19.7 Trump's enthusiastic endorsement of HCQ gave rise to a firestorm of misinformation, causing an uproar within the scientific community.8

Leading infectious disease experts heavily criticized the study that initially suggested HCQ might be effective in treating COVID- 19.9 Critics argued that the reliability of the study was undermined by major methodological flaws, as the "small randomized trial suggesting benefit was unblinded, and some patients received concomitant steroids or antivirals."10 Director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, a vocal critic of the study, contradicted President Trump by stating that all "valid" scientific data showed HCQ was not an effective COVID-19 treatment.11

Those most impacted by the political rhetoric and misinformation were the patients, like Dale, who take HCQ as an evidence-based treatment for their autoimmune diseases.12 These patients faced drug shortages, supply chain issues, and additional hurdles in getting their prescriptions filled.13 This was largely due to the eightyfold increase in HCQ prescriptions from February to March 2020, when a significant number of new HCQ prescriptions were written by practitioners who did not routinely prescribe the medication.14

This Article details how a critical lack of regulation over the practice of off-label prescribing ("OLP") resulted in this potentially deadly crisis. Several states reported that health care providers, including dentists and ophthalmologists, illegitimately prescribed HCQ for themselves and their friends and family, or as prophylaxis and treatment for patients with COVID-19.15 In evaluating key areas of potential oversight, this Article examines the roles of pharmacists, physicians, the United States Food and Drug Administration ("FDA"), and health licensing boards in mitigating a similar crisis in the future. Through the lens of the HCQ crisis, this Article advocates for health licensing boards to implement effective,evidence-based drug regulations to ensure full and uninterrupted access to essential medicines during public health emergencies.16

Section II explores the relationship between the FDA and the states regarding the practice of medicine and, by extension, OLP, a widely accepted aspect of medical practice.17 Section III evaluates current off-label drug regulation strategies and argues that targeted, state-level solutions are the best approach in this context. Section IV details the three categories of state action on HCQ access: (1) states that failed to issue any publicly-available guidance; (2) states that issued prescribing and/or dispensing recommendations to licensees; and (3) states that issued emergency rules explicitly limiting the prescribing and/or dispensing of HCQ. Section V proposes a set of model off-label drug regulations and concludes with a review of potential legal challenges to these regulations.

Although the HCQ crisis has largely dissipated, critical lessons can be drawn from the experience. First, policymakers must understand that social media-driven scientific misinformation has a direct effect on public health.18 Second, OLP remains largely unregulated, and therefore, patients like Dale are one misinformed social media campaign away from dealing with a similar crisis in the future- an increasingly significant threat due to the rising likelihood of future pandemic events.19 Third, health licensing boards have the authority to promulgate regulations that ensure access to essential medicines for patients with chronic illness.20 Accordingly, this Article proposes evidence-based, off-label drug regulation strategies that seek to preserve medical resources for patients with chronic illness without stifling clinical innovation. In striking this delicate balance, health policymakers must implement fact-based policies to combat the effects of rising anti-science bias and to protect patients like Dale from becoming collateral damage in a political warzone.21

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