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Herrin: FDA Denying Patients Fundamental Freedom of Choice


By Christina Herrin, Director, Free to Choose Medicine


As COVID-19 continues to wreak havoc across the United States, Americans need the freedom to try potentially life-saving medicines. Unfortunately, the U.S. FDA’s antiquated, rigidly bureaucratic structure is making this impossible – and it needs to change now.


The Heartland Institute launched the Free to Choose Medicine (FTCM) project to give voice to patients and doctors who urgently want to reform the FDA’s outdated drug approval process. Many Americans want the freedom to try promising medicines before they’re fully approved by the FDA – and they should have it.


In the current FDA approval process, it takes more than a decade and costs over $2.6 billion on average to bring a new drug to market – and only then are patients permitted to use it. This incredibly expensive, hugely time-consuming process has kept life-saving medicines out of reach for many patients while the bureaucratic wheels have slowly turned. It’s no surprise that 92 percent of voters want the FDA to make “prescription drugs better, available sooner, and at a lower cost.”


The COVID-19 pandemic has shone a bright light on the agency’s shortcomings, as FDA has discouraged the use of hydroxychloroquine even as studies show it saves Americans’ lives.


New research from the Henry Ford Health System found that treating COVID-19 patients with hydroxychloroquine significantly cut death rates, and with no adverse events. Used in combination with azithromycin and zinc, the drug has shown positive outcomes against COVID-19 in multiple studies. These studies affirm a growing body of similar evidence from studies around the world. Why are they not getting more attention?


Hydroxychloroquine was approved by FDA nearly 70 years ago and is used to treat Alzheimer’s, Lupus, and dozens of other diseases. Even better, it is an off-patent drug that is widely available and affordable. Yet FDA has discouraged the use of hydroxychloroquine to treat COVID-19 outside of a hospital setting and greatly exaggerated its potential safety risks.


The use of this drug as a viable treatment for COVID-19 should be left to doctors and patients – not government bureaucrats who have political agendas and no skin in the game.


This problem predates COVID-19 and will outlast it yet. When government agencies dictate one-size-fits-all “solutions,” individuals are typically left with fewer options. This is why FTCM campaign is advocating to allow patients and doctors to take control of their health care decisions with the freedom to try medicines that are in the process of clinical review.


After completing Phase I safety testing and at least one Phase II efficacy test, potentially viable treatments should be marketable even without FDA’s full seal of approval. This would save time and cut costs. And most importantly, by creating a pathway for promising treatments that have not yet received FDA’s stamp of approval, we would give patients more control over their lives – which may well hang in the balance.


For decades, FDA has delayed access to potentially lifesaving treatments by putting too much emphasis on agency protocols and bowing to political pressure. Hydroxychloroquine is only the latest example of the agency injecting politics into the regulatory process – and putting the needs of its bureaucrats above the needs of Americans with debilitating and terminal conditions. The goal of FDA ought to be to promote innovation at the highest level instead of acting as a barrier to promising treatments.


Christina Herrin is the director for Free to Choose Medicine, a project of The Heartland Institute, a non-partisan, free-market think tank headquartered in Arlington Heights, Illinois.