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It's Time to Sideline the FDA

The coronavirus pandemic, now going into its eighth week, has exposed so many flaws in our nation’s healthcare system. We have shortages of doctors and nurses because of restrictive licensing requirements. We have a shortage of equipment because of trade barriers stemming the flow of materials from abroad. We also have a shortage of money because of our government’s reckless spending on other nonsense over the years.

One thing we’re also running short on is time. More than 30 million people have now filed for unemployment. We simply cannot afford to hamstring our economy the way we have for much longer. Certain state governments and federal government officials have expressed hesitancy to reopen America until we have a vaccine available. Dr. Anthony Fauci has said it’s “doable” that one could be developed and ready to go within a span of a year to 18 months. He noted this is well ahead of the normal schedule for a vaccine, which is 5 to 10 years.

This begs the question: Why does it take that long? In addition to the shortages listed above, data shows that the U.S. is dealing with a number of drug shortages. This is in no small part due to the absurd web of regulations the Food and Drug Administration (FDA) makes manufacturers jump through to get a drug or vaccine to market. One has to wonder how many thousands (or potentially millions) of people died preventable deaths while the FDA spent almost a decade making sure every ‘t’ was crossed and every ‘i’ was dotted on a potential cure.

With the coronavirus, there are more than millions of lives at stake. There are also tens of millions of livelihoods at stake. Yet, even the most generous estimates say that we won’t have a vaccine before the end of this calendar year. In the meantime, millions are going to struggle to feed their families and we’re going to lose a good amount of elderly and immuno-cmpromised Americans. The pressure everyone is feeling has exposed how agonizingly slow the FDA process is and has crystallized how unacceptable it is.

However, this has always been unacceptable. It’s simply more obvious now. The question that exists now is how we are going to remedy not only the coronavirus, but the FDA. The answer, as in almost any functioning marketplace, is to introduce competition: other options. The FDA operates with impunity and no one has had any option but to work within its framework, and our country has been worse for it.

The time has come to break up the traffic jam on the proverbial FDA highway by providing an exit lane. That exit lane would be a proposal known as “Free to Choose Medicine” and it would exist independently of the FDA.

As outlined in the picture above, the Free to Choose track would bypass the FDA. Manufacturers sufficiently confident in their development could elect to put their products on the Free to Choose track. At that point, patients could have informed discussions with their doctors about whether or not that path would be right for them. Naturally, this includes manufacturers educating doctors about the drug and the potential risks involved.

No drug or vaccine is ever 100 percent safe. That is the nature of this business. There are always rare, unforeseen side effects that can pop up. However, that is no reason to relegate millions to helplessness who could have the option to live.

Many Americans are dissatisfied with the healthcare system in America. However, every proposed solution by mainstream politicians includes reforms to the existing system. America needs to consider the reality that the existing system is broken and that if we want to build a functioning system, it has to operate outside of the constraints of our current one. That’s what Free to Choose offers. If coronavirus has taught us anything, it’s that we need something radically different than what our leaders have to offer us now.