Free the Innovators from the FDA

For more than six weeks, Americans have endured the hardship and uncertainty of a lock down. Millions of businesses have been forced to close, and many will never reopen. Tens of millions have lost their job, and with the closure of so many businesses, it will be difficult for many to find work.

This unprecedented economic destruction was necessary, we have been told, to slow the spread of COVID-19 so that the health care system would not be overwhelmed. If we did not “flatten the curve,” we would face a shortage of ventilators, personal protection equipment, intensive care beds, and the medical professionals to care for the ill. In short, we were told that the nation faced a supply shortage.

The government’s response was to slow the increase in the demand for medical care. A dramatic spike in COVID-19 cases would overwhelm the health care system, but if we “flattened the curve,” those cases could be spread out and the existing supply of health care equipment and professionals would be better able to handle the demand.

Though public officials and health care leaders openly acknowledged the supply shortage, virtually none of them questioned why this was the case. To do so would require them to challenge a deeply held premise.

The fact is, the shortage was caused by government’s stranglehold on health care. And that stranglehold is led by the Federal Death Agency (more commonly known as the Food and Drug Administration, or FDA). There is no medical product–equipment, personal protection attire, drugs–that can be legally sold in the United States without the approval of the FDA. And that approval can take years and cost billions of dollars to obtain.

(The FDA is not the only culprit or cause of the health care shortage. As one example, occupational licensing of doctors, nurses, and other health care professionals creates artificial barriers to entry and often prohibits them from practicing across state lines. As another example, “certificates of need” often prevent hospitals from expanding their facilities.)

The various approvals and restrictions imposed by government stifles innovation. Who wants to spend years of their life and insane amounts of money simply to get the approval of the government? It is an extremely risky endeavor to develop a new health care product. If the innovator does not receive permission from the FDA, he cannot legally sell his product. His time, effort, and money will have been wasted because he did not satisfy the arbitrary criteria of government bureaucrats.

In response to public outcry and pressure from some politicians, the FDA has relaxed its rules and granted “emergency use authorization” to many medical products. In the midst of this crisis, the government is giving innovators a small sliver of temporary freedom to develop and market new products. At the same time, it is giving doctors the freedom to use drugs such as remdesivir and hydroxychloroquine, both of which have been approved by the FDA as safe and effective in treating other diseases. But these freedoms are only temporary, and they are being given, not as a right, but as a permission. And according to the “emergency use authorization,” that permission will be withdrawn once the crisis abates.

Many have applauded the FDA for relaxing its rules, recognizing (if even only implicitly) that fewer restrictions on the innovators will save lives. But few are questioning why the innovators should ever need the permission of government to develop and market a product, whether it is for health care or anything else. They want the innovators to save us during an emergency, and when the emergency is over, they want the innovators to be controlled, restricted, and regulated.

The crisis we are facing today is the result of decades of controls, restrictions, and regulation of the innovators. The innovators create and produce the values that we want and need to live. Controls, restrictions, and regulations stifle or stop the production of values. Nobody know what values we might enjoy, and what crises we might avoid, if the innovators were free.

That the FDA has relaxed many of its rules is an open admission of this fact. It relaxed its rules in order to stimulate the production of values. Even with a small amount of freedom, the innovators are responding in heroic fashion. As one example, a team at the Massachusetts Institute of Technology developed a face shield and began producing 100,000 shields a day within a few weeks.

Fundamentally, the FDA operates on the premise that neither producers nor consumers should be free to act on their own judgment. Producers must have the FDA’s permission before it can sell its products. Consumers must have the FDA’s permission before it can consume products that they think will benefit their lives.

In this crisis, relaxing the rules may save tens of thousands of lives. But why should we relax arbitrary rules only when tens of thousands are threatened? An individual suffering from a serious disease other than COVID-19 is facing a personal crisis. To him, his situation is no different than that of the individual victims of COVID-19–it threatens his life. If he decides, in consultation with his doctor, that a particular drug or treatment shows promise to cure him, there is no rational or moral reason why he needs the permission of government bureaucrats to try that drug or treatment.

Freedom means an absence of coercion. It means the freedom to act on one’s own judgment regarding what is best for his life. That is true in a crisis, and it is true when there is no crisis.

If we are truly interested in saving lives, we must advocate the policies and principles that protect the freedom of the innovators. And that means abolishing the Federal Death Agency. Free the innovators from the arbitrary dictates of the FDA.