The FDA: Abolish It. It Does More Harm than Good.

The Food and Drug Administration (FDA) is the poster child for good intentions producing terrible results that harm people. Abolishing the FDA is one of the easiest stances for a rational person to take, particularly with regard to pharmaceutical drugs. Most people think that the FDA protects consumers by regulating and approving what drugs can go onto market so that we don’t get hurt by the dangerous drugs. This is incorrect. First, I’ll briefly describe the moral argument for abolishing the FDA’s regulation of drugs. People should be able to do as they please as long as they are consenting adults. If someone wants to put a certain drug in their body, that is their free will choice. Violating that freedom with force is immoral. Even if there are some risks associated with that drug, or it hasn’t been tested a lot, a person has the right to make that judgment themselves and take that risk. Imagine two adults consensually trading, where person A offers to give person B some medicinal pill, and person B offers to give something else (money) to person A in return. This should be permitted. Then, person C (government, or anyone) barges in and says “no” and forcibly stops this activity because they think they are the boss of everyone else. That’s the FDA, and their actions are immoral. Now, let’s consider the consequentialist arguments.

Before describing how the FDA does terribly more harm than good, I will describe the basic way a free market would work if it were allowed to. Businesses want to make money. They make money by selling you things that you value. They generally have an incentive to produce something that is good. That way, they can sell more of it. If they sell something of poor quality or that is dangerous, then consumers, stores, and doctors tend to stay away from it. There is still drug testing in a free market. Drug companies do their own research and testing because they want to determine if a drug is useful and can succeed on the market. Independent certification companies also do testing. If a drug was found to have some seriously negative side effects, people would stop taking it. Doctors would advise their patients not to take it. Stores that wish to remain reputable among consumers would tend to not sell it. And, the media coverage would be on it, and so forth. Remember that there is no such thing as a perfect, risk free life with 100% safety. Even the drugs that come out of the FDA have potentially dangerous side effects. A lot of drugs have some problems, but they are meant to be used if the benefit of treating the illness outweighs the risk of negative side effects. It will always be the case that people make mistakes. Some inventions don’t work or are dangerous. But, in a free society, different things are tried out. The failures fade away, and the successes become more prominent. A free market quickly self-corrects for mistakes. Also, depending on the terms of the sale, if a drug is dangerous and kills people, then the drug company can be sued for a lot of money and be demonized in the media. Such companies then tend to die out. It is not good business to sell unsafe drugs. For the drugs that are beneficial, doctors continue to recommend them, people tell their friends about their success, and generally these become the commonly used drugs.

Various third party organizations are formed in a free market to help consumers. Some organizations or companies may serve to “certify” certain drugs. If consumers, stores, and doctors generally trust such a certification company, a drug company will want this certification company’s “stamp of approval” so that their drug will sell better, and they would go through the testing of that certification company. This is not wishful fantasy theorizing. These types of companies already exist and used to play an even larger role in the market before government replaced them (Underwriters Laboratories is a major certification company for many consumer products and started in 1894). Doctors also act as a third party to help consumers choose which drugs to take.

Some organizations would exist just to act as a forum to share experience between consumers. Angie’s List is an example of this in our times. Angie’s list is a website where consumers of various businesses (electrical, plumbing, auto-shops, construction, etc.) rate their experience according to various criteria. The businesses that perform well for consumers get better ratings, and the next consumers tend to choose the businesses that have good ratings. Angie’s List charges a subscription fee. Consumers who value the opinion and experience of other consumers pay the fee to see the ratings. Everyone has the incentive to make the process work and do a good job. (By the way, what if we one day find out that Angie’s List has become corrupted with fake reviews and ratings due to businesses bribing them? You might say this means that free markets actually don’t work. However, the same corruption happens every day in the government, so remember to apply your performance standards equally. And, let’s compare corrective action. If Angie’s List becomes corrupted, people can quickly leave it and stop buying from those businesses immediately, along with filing fraud lawsuits against Angie’s List for violating contract terms. However, if it’s the government that’s found to be corrupt in something, it requires the slow politicized government, and maybe even Congress, to take correct action, and you probably won’t be able to sue.)

For an excellent video on free market product safety relationships in general, see this video:

So, the free market would already cause most drugs to be safe. What everyone is worried about is the chance that sometimes an unsafe drug will be sold. Even though the drug’s dangers would be uncovered in time, it is still the case that some people initially can be harmed. A free market has more freedom to experiment and save lives, but there is also more risk, and consumers would admittedly have to be more careful about what they buy instead of flippantly grabbing anything off the shelf. You may reply, “But, most people aren’t careful or smart about what they buy. Most people assume that anything on the shelf is good for them.” Indeed, today, many people don’t have such a careful attitude, but this is because the government has conditioned us this way by setting up such regulatory agencies that ensure that we don’t have to be careful. What I’m saying is that once the current system of government assurance is over, a different system will replace it and people would adjust accordingly. People tend to do things according to need. If an attitude isn’t needed, it isn’t practiced. When the government assures all safety for all products, we don’t have to be careful about what we buy. But, in a free market, where people need to be more careful about what they buy, they will eventually learn this trait to the extent necessary, just as today we all know to look both ways before crossing the road. So, a free market society would also develop more cautious buyers. This in turn actually strengthens my case that bad drug companies with bad reputations would die out quickly, while reputable safe companies would thrive. Reputation would become quite important.

Now, how does the FDA’s approval process do so much harm? The FDA can make two types of mistakes regarding drug regulation.

1. They can approve a drug that is unsafe, causing the harm of people who take that drug. The victims and the harm done are easily visible to the public. The public sees the unsafe drug and correctly blames that drug. Or…

2. They can outlaw or delay the availability of safe drugs that could have helped people and even saved lives. In this case, the FDA is overly careful and people are in pain or die who could have been helped by the drug if it was available. The victims are hidden because the public sees the deaths and pain as a result of the illness itself, and don’t realize that there could have been a drug that could have helped. For those who die, the public doesn’t know that they could have been saved.

It turns out that real world incentives cause the type 1 mistake to rarely happen, but the type 2 mistake to occur very often. Imagine a bureaucrat at the FDA who is in charge of approving a drug. The bureaucrat knows that if he makes the type 1 mistake of approving an unsafe drug, a scandal will break out where he will be seen as directly responsible for the deaths caused by the that drug, and he will be demonized by the media, probably fired, hauled up for congressional hearings, and will live the rest of his life knowing the specific visible names of those he “killed”. He has incredible incentive not to commit mistake type 1. But, if he commits mistake type 2 of banning or delaying a good drug, he will not be seen as directly responsible for the deaths caused, the media will not know that there could have been a drug to save some of the people who died of a certain disease, so they will not demonize him for “being careful”, he will not be fired or hauled up for congress, and he will never know the specific names of those who died because they didn’t have the good drug. He will not be rewarded for avoiding the type 2 mistake. His incentive is to then be extremely overly careful for every single drug application that comes his way, erring on the side of near zero risk. He will do everything to avoid committing the type 1 mistake, including making the type 2 mistake over and over again. It’s hard to blame him for protecting his self-interest, as we all might do the same in his position. And this is what happens with all the bureaucrats, as we see next.

Due to over-caution, the FDA adds about 10 years to the approval of any drug. And, it takes about $500 million to get any drug through the FDA testing process. Anyone who knows anything about the FDA knows it takes so many years and so much money to get through the process. This causes many companies to not even attempt to produce a good drug simply because it is too costly to get through this process and they don’t know if they will be able to recover that cost from the potential profits of the drug on the market. Dr. Mary Ruwart, pharmaceutical research scientist for Upjohn Pharmaceuticals, described the case of her company creating a potential drug cure for liver disease when there was no cure for it. Even the FDA was excited about the new drug and wanted them to put it on the market. But, because it was such a new drug type, the FDA approval process would be even more strenuous than usual, and if the first tests weren’t done with the correct amount of patients or dose ranges (something you can only tell after the first tests are done), then the long testing process would have to start all over again. The drug company estimated that the time it would take to go through the tests would be so many years that their patent would run out by the time the drug might be approved, meaning that it would go generic, and causing the company to never be able to recover their initial high costs of FDA testing. For this reason, they stopped their plans for this drug. The FDA made it too expensive for this company to innovate, develop, and market this potentially life-saving drug.

A witness to this travesty is seeing certain drugs that are available in other westernized developed countries benefiting their patients, when these same drugs are banned in the U.S. An example was beta blocker drugs used to prevent second heart attacks. These were available in other countries with less stringent regulations, but were banned in the U.S., causing about 10,000 deaths per year. In the 10 year period following the 1962 FDA regulations, not one drug was approved for hypertension, where several were approved in Britain. From 1967-1972, only one drug was approved for the entire cardiovascular area. (The above information is from the Free To Choose series by Milton Freidman).

And, what about the drugs that do make it through the 10 year, $500 million testing process? How much pain persisted and how many people died during the 10 years waiting for this drug? Every time the FDA praises itself for approving a new drug that saves, say, 15,000 lives per year, then that means that for the previous 10 years, 15,000 people died per year, totaling 150,000 deaths because of the FDA’s delay process.

It’s true that sometimes the FDA can save some lives because it correctly outlaws a bad drug. But a drug that a company wishes to sell is rarely going to be bad, because it is bad business to sell bad drugs. And, a free market would still correct itself once a bad drug is realized. As I said earlier, I’m not claiming that a free market would perfectly eliminate all unsafe drugs, I instead claim that the sale and use of unsafe drugs would be relatively rare due to market incentives and how people naturally act. So, if unsafe drugs would be a relatively small problem in a free market, then the FDA’s positive impacts can only be small. However, as discussed above, frequently committing the type 2 mistakes, delaying all safe drugs (all drugs must go through FDA’s process), and/or preventing the sale of some safe drugs entirely (by never being produced) will predictably, reliably, and necessarily cause large amounts of death and pain. So, the net result of the FDA is overwhelmingly skewed toward killing people by restricting and delaying good drugs. A free market will also have some death and pain, but we must compare the two systems for which one has greater harm. The net effect of the FDA is much more death and pain compared to a free market system.

A particularly disturbing scenario is of those who are suffering from an illness that they are almost certain to die of when there aren’t any currently available cures. In such a circumstance, they would want to try and buy a new experimental drug that maybe hasn’t been tested a lot. Sure, there is risk, but the patient has nothing to lose and is going to die anyway. But, no, too bad for them. The FDA thinks the drug is too risky due to lack of testing, and so the patient dies with no chance. Their only hope is to buy it on the black market or maybe go to another country if it’s legal there.

Besides more death and pain, the FDA’s expensive process causes the price of drugs to skyrocket because those testing costs are passed to consumers, making it more difficult for the poor and middle class to afford. It also costs a lot of tax money to pay all of the bureaucrats. And, the FDA’s process is so expensive that it promotes big business. After all, only the richest and largest corporations can afford the team of lawyers and upfront capital to go through the FDA’s process. The FDA’s barrier to free trade helps to eliminate competitors. And, like usual, many of the largest corporations actually write the regulations themselves in order to create special privileges and barriers to competitors. The FDA helps to create and sustain monopolies, and monopolies result in even higher drug prices on top of the effect of the expensive approval process. Today, many progressives and statists blab about how people can’t afford expensive drugs and call for the government to help us against the evil greedy corporations, but they forget that it was the government that caused the high costs in the first place. The simplistic statist only sees the surface level, direct, and apparent effects of an action, the libertarian sees these and also the hidden effects. By abolishing the FDA, we can save many lives, much pain, and a lot of money.

Leave a Reply

Your email address will not be published.