A World Without the FDA
Drugs Would Be Riskier, but Current Safety Rules Have Costs
Back in 1980 I had the good fortune to spend a summer in Santiago, Chile. My woeful high-school French produced an even more woeful Spanish, but I was able to travel about that beautiful country with wonderful people.
In the middle of my stay I developed a fearful cold and wandered into what looked like a drugstore in search of comfort for my ailing throat, nose, and head. I picked up a bottle of this, a bottle of that, and tried to puzzle out their purposes. I quickly realized that my command of Spanish, while adequate for getting around on the bus or in the grocery, was a major handicap when trying to figure out the ingredients and expected impact of any of the products lining the shelves.
As I stood there peering at labels, it occurred to me that there probably was not a Chilean equivalent of the Food and Drug Administration. I remembered the time my father had surgery overseas. His post-operative condition was an emotional roller coaster: he found out later that he had been given cocaine as an anesthetic.
My problem went beyond my language deficiency: I was about to take on more risk than I was accustomed to in the United States. After years in the risk-free world of the American pharmacy, I was uneducated and unprepared for the choices on the shelves before me. I decided to endure my ailments drug-free.
My ignorance was the rational result of growing up in a world where the drugs that have any impact are only available by prescription and the ones available over the counter are about as dangerous as the candy in the next aisle. But if there were no FDA and if any drug were available over the counter, my incentives to become educated would change.
Voluntary Testing
The world would change in all kinds of interesting ways. Let’s try to imagine what that world might look like. No FDA. No prescriptions. Any drug could be sold over the counter. And for simplicity, when I speak of drugs I mean purely medicinal drugs, even though my father’s experience might make that a tough line to draw in practice.
Would drug companies test their drugs if tests were voluntary? I don’t think drug companies’ profits would be enhanced if their customers died from using their products. They would test their drugs. Would they test them as thoroughly as they are required to do now by the FDA? I doubt it.
Drugs would be riskier. Is that good or bad? We tend to think of drugs as safe or unsafe. But no drug is completely safe. The only way to avoid the side effects of drugs is not to take them. And most of us understand that as long as the risk is small enough and the benefits large enough, putting foreign substances into our bodies is a good idea.
What is more difficult to accept is the possibility that a drug can be “too safe.” Under current drug regulations, it takes years of testing to get FDA approval. There is no free lunch: making drugs as safe as the FDA requires has costs.
Some worthwhile drugs for uncommon diseases never make it to market because the costs of proving their safety and effectiveness aren’t worth it. Other drugs are worth it, but while waiting for FDA approval, people are dying or suffering. Finally, there are risky drugs the FDA rejects but that a patient might be willing to take a chance on. Without the FDA, there would be a lot more choice in the marketplace.
And with choice comes a lot more risk. That increase in risk would encourage consumers to become more educated. You could insulate yourself from that risk by using your doctor as you do now: as the gatekeeper to the dangerous world of drugs. But we would have the freedom to have a different relationship with our doctors. Many of us would take greater responsibility for our decisions by using a doctor as a resource rather than as a surrogate parent.
Most of us will not want to master the effects of drugs, even with a doctor’s help, so we will also have a demand for other sources of good information. With the government out of the business of risk control, there will be a large profit opportunity to provide reliable information on drugs and how they work. The Internet is one way to provide that information.
Perhaps a private nongovernmental version of the FDA would come into existence akin to Underwriters Laboratory or Consumer Reports, certifying drugs as having a particular effect on an ailment or not having particular side effects. Such testing would be expensive, but drug manufacturers and consumers might be willing to pay a premium for drugs that had been extensively tested and certified independently. There might be different organizations with different standards of effectiveness or safety certifying the effects of drugs.
All of the above is mere speculation, an attempt to fathom how the market might respond to the intense demand for information in a riskier world. I can only begin to guess how the market might solve that problem.
All I know for certain is that a world without the FDA and without prescriptions would have more personal responsibility and more choice.
I also know for certain that there would be tragic outcomes as well. Without the protection of the government, some people would be taken advantage of by unscrupulous drug manufacturers and deceptive marketing. Some people would hurt themselves taking the wrong drugs or neglecting various drug interactions.
But others would be saved by the wider and earlier availability of life-saving drugs.
Would a world without an FDA and prescriptions be a better world? The answer depends on how many lives would be lost from mistakes and how many lives would be saved by the wider and earlier availability of drugs. It would also depend on the value you place on putting responsibility in our own hands rather than having the government take responsibility for us.
Comment by Bharat Patel on 26 October 2009:
I think this is very revolutionary idea and thinking. Question is do we need regulation?? In today’s America regulation and more regulation and more regulation is mantra of day. What we in America do is testing impurity at any cost ($ 2.4 trillion pop). Once needs to evaluate FDA’s functionality and strategic approach. Process of New Drug Application is a previlage of FDA operation. They are not responsible for approval of new drug and people dying without appropriate drugs. What new word in FDA book is safety and safty and safty. Unfortunately, there is such thing as safest in both food and drug.
I agree with you on this point. new drugs have been approved based on how best its sponserer present their product in front of FDA reviewer not based on how effective and valuable is drug to common human being.
But I donot agree with you drug industry without FDA. We cerainly, need regulatory body to regulate and comply quality of drug manufacturing process and maeketing it for specific purpose.
Comment by George Schwappach on 26 October 2009:
Good article. You forgot to mention the pharmacist that was available in the store in Chile. Unlike his American counter-part, this professional PERSCRIBES medicines. After his education was complete, the drug companies took over and taught him about the benefits of the various products, much like they do with doctors here in the states.
Chileans aren’t drug experts. They trust their local pharmacists.
Comment by DD on 26 October 2009:
I find the idea expressed by the author that drugs today may be safer as completely baseless and unfortunate, for he did not have to make this concession in order to prove his other point – that “others would be saved by the wider and earlier availability of life-saving drugs”.
The author assumes that “safety” regulation is a tradeoff that can be provided by the government, although at the expense of more readable new drugs. There is no reason to assume that government can provide any meaningful “safety” regulations at all. “Bad regulations drive out good regulations” comes to mind. The author neglects the fact that the sense of false security that the government creates reduces the comparative advantage a drug company would have in offering a “safer” drug to the public. The FDA operates on arbitrary standards and minimum requirements which pharmaceutical companies gain no competitive advantage if they are exceeded.
Pingback by FDA Rejects Treatment for Fatal Disease | The Freeman | Ideas On Liberty on 5 May 2010:
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Comment by Erich on 5 May 2010:
@DD This is a good point. You deserve (1) libertarian cookie.
Comment by Bobbingsworth on 6 September 2010:
It is impossible to know whether or not drugs will be less safe without the FDA since no drugs are allowed to be sold without the FDA’s approval. Alternative certifying companies may do more effective testing.
Since this world without the FDA would not necessarily be a world without insurance companies, I am fairly certain that the drug companies will not be the only ones paying for testing. Likewise, since the world would probably also still have lawyers, Drug companies would probably contractually obligate pharmacists to keep riskier drugs behind the shelf and only sell them to people after a certain amount of screening.
The big problem with simply disbanding the FDA is the transition period. It will take some time for alternative testing companies to start up and much longer for anyone to trust them. The only way I can think of to do this is to make FDA certification optional and, over time scale back the agency until nobody notices it being shut down. So Miracle # 1: find enough politicians with the courage to shut it down. Miracle # 2: keep them honest and in office long enough to finish the job.
Comment by Scott Mc on 31 October 2011:
Only question we need to ask is what does the market want? If it is safe and effective drugs the market can deliver without an fda – as stated how do we get there is the big question.
Comment by George Thompson on 31 October 2011:
About twenty years ago I found a used book that predated the FDA. It was a catalog of drugs available on the market with full descriptions, reccommendations, warnings, etc. written for the average person. Similar books are available today, at least for prescription drugs. The Internet has virtually everything too.
Comment by Tom Langley on 7 November 2011:
There’s also the question of corruption. I think it would be naive to believe that the FDA is not lobbied and “enticed” to see things the drug company’s way. The government sector has no incentive to be truthful, honest, diligent, etc. etc. You find those incentives only in a free market. I like the idea of an Underwriter’s Laboratory in the pharmaceutical context.
This would work in many areas where government now holds monopolies. Building codes and automobile safety, to name just two.
Comment by Drik on 1 December 2011:
The government has decided that pens and pencils with a drug company product name on it geven to physicians are too corrupting for the physicians and will unduly influence their professional jjudgement and cause them to alter their behavior and give substandard care.
Unlike the lobbying of the government and the government agencies who are apparantly not affected at all by lobbyist’s lavish dinners, entertainment, and gifts. No substandard behavior going on there at all.
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