Opinion

COVID-19 Exposes Flaws in FDA Regulatory Framework

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Posted: Apr 13, 2020 12:01 AM
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COVID-19 Exposes Flaws in FDA Regulatory Framework

Source: AP Photo/Andrew Harnik, File

According to a recent poll, 93 percent of voters want U.S. Food and Drug Administration (FDA) reform to allow for faster approval of prescription medicine. With the onset of COVID-19, state and federal regulations are being revoked around the clock so that the needs of the public can be addressed in a timely manner during this crisis.

When President Trump declared a national emergency, he said the declaration will allow Department of Human Services (HHS) Secretary Alex Azar to “waive provisions of applicable laws and regulations to give doctors, hospitals—all hospitals and healthcare providers maximum flexibility to respond to the virus.”

There are extreme societal pressures on the government and private sector to expedite approval pathways at all costs to find an effective therapy or cure in record time for COVID-19.

On March 19,  President Trump stated, “the federal government would accelerate testing drugs to treat coronavirus, seeking to project optimism amid a massive spike in domestic cases of the virus.” FDA Commissioner Stephen Hahn noted, “a vaccine for the coronavirus is currently in the first phase of a clinical trial and wouldn’t be ready for 12 months.” 

The timeline created for a vaccine or therapies to combat COVID-19 is much quicker than that of typical drug approval. In non-pandemic circumstances, it typically takes 12 years and $2.9 billion to bring a drug from lab to patients.

Millions of Americans suffer daily from debilitating diseases. Unfortunately, they are not the benefactors of a massive national effort to fight and ultimately cure their conditions. If it is possible to lift burdensome regulations in times of crisis, it is crucial to examine the necessity of these regulations in the first place. Patients battling debilitating diseases should have all treatment options at their disposal. Needless to say, they should also have the ability to avoid the tangled web of FDA regulations that block and blunt potentially life-saving therapies from the hands of willing patients.

Free to Choose Medicine (FTCM) is a policy proposal that offers a comprehensive solution to the convoluted and overregulated FDA drug approval process. During times of a health crisis that include strong societal pressure similar to that of AIDS/HIV, Ebola, and now COVID-19, what seems to follow is expedited approval of a treatment, and deregulatory measures meant to bring lifesaving medicine to the public as quickly as possible.

FTCM allows for treatments that have not yet been approved by the FDA, but have passed safety testing and at least one efficacy test to be marketable to patients who have exhausted all other options. FTCM also implements the use of a Trade-Off-Evaluation-Drug-Database (TEDD) that would act as a collection of protected patient data available in real time. This would allow patients and doctors to track and analyze data to better hone treatments on an individual patient basis.

There is power in knowing that expedited approval for life-saving treatments is possible and works in times of a health crisis. Logic would dictate that this special process should also be applied to expedient approval of other drugs, especially for those suffering from terminal and debilitating diseases. ALS, Alzheimer’s, cancer, to name a few, are disease groups that impact all American families. Everyone knows of someone who has died from a similar disease, yet the nation stands idly by until there is a pandemic to initiate measures to address these health emergencies. 

Bolstering the expanded access process by implementing a FTCM track is a solution for the silent majority of patients who are suffering daily. It shouldn’t be the case that billions of lives have to be at risk and a pandemic ensue before the convoluted FDA regulatory framework is finally reformed.