HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Tuesday, September 15, 2020

The President’s Remedy: Taking Another Look at Off-Label Prescribing in the Context of President Trump’s Relentless Promotion of Hydroxychloroquine

Jennifer Bard (University of Florida), The President’s Remedy: Taking Another Look at Off-Label Prescribing in the Context of President Trump’s Relentless Promotion of Hydroxychloroquine, SSRN:

In the spring of 2020 the world watched as the President of the United States became “Salesman-in-Chief” for a long outdated FDA approved malaria drug, which he called HYDROXYCHLOROQUINE, as a miracle cure for Covid-19. Although not approved by the FDA for use outside of a hospital, the effects of the President’s advocacy became visible almost immediately. Prescriptions for the drug increased to a point that it became difficult to obtain for patients who depended on hydroxychloroquine for its other FDA approved uses, Lupus and rheumatoid arthritis.
But the prescriptions weren’t for Covid-19 patients. They came from a wide range of health professionals stockpiling the drug for themselves, their family, and the worried well. This was all legal because once a drug is approved by the FDA for any use, it can, through a backdoor process called “off-label” use, be prescribed for any purpose.

“Off-label prescribing” has become so integrated into contemporary medical practice that by some estimates up to 80% of oncology drugs and a substantial percentage of psychiatric drugs are prescribed off-label. Increasingly, researchers around the world have found that contrary to the beliefs of the doctors who prescribe off-label, the results for patients are often poor. Yet the practice is so powerful that it has evaded all attempts to implement commonsense measures such as like mandatory tracking of off-label prescribing. Moreover, in no state must a doctor specifically inform a patient when they prescribe off-label.
In light of events like the President induced run on hydroxychloroquine, now is the time to revisit the continued existence of a practice more suited to a time when doctors made house-calls by horse and buggy than today’s world where genomics and AI have revolutionized medical practice and drug development. It may be several years before we know how much death or cardiac damage was caused by the unnecessary use of hydroxychloroquine for treating Covid-19, but this very public display of how off-label prescribing can be abused needs to be a catalyst for getting the states and the FDA working together to develop a patient centered approach that creates a framework for assuring that everyone who is prescribed a drug can rely that it has been proven safe and effective.

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