The U.S. Food and Drug Administration (FDA) has recently developed an expedited drug approval system for possible therapies to treat coronavirus. This program, known as the Coronavirus Treatment Acceleration Program (CTAP), was quickly established as the COVID-19 virus became a pandemic and wrought economic and societal devastation in its wake.
According to FDA, “The program uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. It is providing “ultra-rapid” responses and completing review of single patient expanded access requests around-the-clock.”
First, I applaud FDA in their effort to accelerate the drug approval process for coronavirus. However, why does FDA not grant this same type of expediency for all sorts of other deadly diseases? By expediting expanded access requests to address all disease groups with the same level of urgency, FDA could put other treatments and therapies on warp speed.
Put another way, it is time FDA put in place the same principles under CTAP on a wider scale, so the same strategy used to combat coronavirus can be applied to other diseases that inflict as much, if not more, pain, suffering, and death.
Fortunately, for FDA, a commonsense plan to meet these needs has been created by The Heartland Institute: Free to Choose Medicine (FTCM) is the pathway for millions of patients suffering from debilitating and terminal diseases.
As COVID-19 has put the world on edge and scientists scramble for a therapy or vaccine, we are now getting a taste of what patients with diseases like ALS, cancer, and Alzheimer’s go through on a daily basis. They live in constant fear, desperate to try any drug (that has undergone reasonable testing) that could literally save their lives.
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As the world searches for a vaccine for COVID-19 and all levels of government begin to deregulate and reform processes to expedite approval, it should make us all question why those inefficient processes aren’t reformed for other disease groups as well.
The CTAP program shows FDA is well aware of its shortfalls and able to vastly improve upon approval times and lower research and development costs when the whole nation (and world) is watching. Again, with political and societal pressure from this current virus, the need for a vaccine is of the highest priority for FDA. But I can assure you the patient suffering from ALS, cancer, or Alzheimer’s believes finding a treatment for their disease is of the highest priority too. I bet their friends, families, and doctors would agree.
You would think in a country that prides itself on individualism, every person who is suffering from a debilitating disease would be granted the same level of urgency that COVID-19 is receiving.
What a cruel and inhumane system we have developed and perpetuated. Normally, it takes on average of 12 years and $2.9 billion to bring a drug from lab to market. As we have seen, this is not the case for viruses like COVID-19. When pandemic strikes, rigid rules are abandoned. All measures are taken to save as many lives as quickly as possible.
If FTCM were implemented, millions of patients would benefit because drugs that are deemed safe and pass initial efficacy tests would be brought to market sooner and at a lower cost.
FTCM was the blueprint for CTAP. Now it is the responsibility of FDA to apply this same commonsense and moral approach to other disease groups, especially for those with debilitating and terminal illnesses. This is the solution millions of patients are begging for. FTCM will literally save untold numbers of lives and improve the health and wellness of all Americans.
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