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If the COVID-19 crisis has taught us one thing—aside from the need to wash your hands often—it is that the U.S. Food and Drug Administration’s (FDA) approval process for much-needed medicine to those with debilitating and terminal diseases is in dire need of imminent reform.
Of course, naysayers will argue that expediting FDA’s drug approval process will result in drugs and therapies hitting the market before they have been adequately tested for safety and efficacy. In short, these people are flat-out wrong.
Moreover, some will say legislation such as the Right to Try Act, which allows patients with terminal illnesses to access potentially life-saving treatments, has already solved this problem. Although Right to Try is a step in the right direction, it does not go nearly far enough in rooting out the decades of rot that has infiltrated and contaminated FDA.
In general, as the COVID-19 pandemic has demonstrated, FDA’s drug approval process is so laden with red tape and unnecessary regulations that it takes on average 12 years and almost $3 billion just to bring a single drug from lab to market.
Think about that for a moment. Apparently, FDA’s drug approval process has become so insanely expensive and burdensome that it takes more than a decade and a whopping $3 billion for a single drug to be deemed safe.
Now, if you are one of the millions of Americans with a horrific disease such as Alzheimer’s, cancer, or ALS, would you rather wait for 12 years for a bunch of bureaucrats to allow you to take a medicine that could literally save your life or would you desire the freedom to choose whether or not you would like to voluntarily take a drug that could slow, if not cure, your condition?
Fortunately, for those in favor of the latter option, The Heartland Institute’s Free to Choose Medicine project provides a commonsense outline to rework the hopelessly antiquated FDA drug approval process for those with terminal conditions who have exhausted all FDA-approved treatment options.
In short, Free to Choose Medicine allows patients and doctors, not busybodies employed at the FDA, to determine the best course of treatment after all other “approved” options have been tried and failed. FTCM would also create a Trade-Off Evaluation Database, with rigorous privacy protections, so doctors and patients can track, in real-time, the progress of drugs and therapies to help them make better-informed decisions concerning treatment options.
Now, just imagine that you (or a family member or friend for that matter) has COVID-19. As of now, treatment options for this deadly disease are few and far between. However, there are drugs (such as Hydroxychloroquine) that have helped some patients recover.
Although FDA has not rigorously tested the efficacy of such drugs for use by COVID-19 patients, if you are on death’s door due to COVID-19, shouldn’t you have the ability to try anything (within reason) that could assuage your ailment?
Because there is no vaccine for COVID-19 yet, millions of Americans could potentially experience a situation like the dilemma described above. In America, the land of the free and home of the brave, it is incredible that we remain at the mercy of FDA regulators when it comes to the choice of taking a drug that could prevent needless pain and suffering, let alone death.
By no way whatsoever am I trying to portray FDA officials as cold-hearted apparatchiks who worship rules and regulations over the health and safety of their fellow Americans. Of course, without a doubt, FDA functionaries are simply abiding by agency protocols.
However, that in and of itself is a massive part of the problem. As Americans, we must not let the bureaucratic process take precedence over commonsense. To make this point as vivid as possible, if an American is suffering from a terminal form of cancer, he or she should have every right in the world to try anything that could prevent his or her death, as long as his or her doctor give the go-ahead.
The doctor-patient relationship is sacrosanct. Doctors take a sacred oath that they will do everything in their power to ensure the health and safety of their patients. Last time I checked, FDA officials were not held to the same standard.
Long story short, for those with COVID-19 or any other potentially life-threatening disease, the groundwork and notion within Free to Choose Medicine should be the status quo, not the rare exception.