All Commentary
Thursday, January 4, 2018

How To Improve The Role of FDA Approval

Some percentage of the consumer base would still value the quality assurance of approved drugs.

In November of 2017, doctors attempted the first ever gene-editing therapy in a human, attempting to cure Hunter syndrome in a 44-year old patient. This is a genetic disorder that affects the body’s ability to metabolize a specific macromolecule in the body. If this approach works, it will be a clinical milestone and spark the hopes of patients inflicted with similar metabolic disorders.

Unfortunately, these hopes might be misplaced. Widespread applications and treatments using this gene-editing technology will likely be delayed for much longer than the actual time it takes to develop effective treatments. The reason is the coercive power of the Food and Drug Administration (FDA).

The FDA Doesn’t Need Force to Serve Its Function

Not only does the FDA require extensive testing of medical treatments, but they exercise coercive power that prevents people from using non-FDA-approved drugs. Their use of coercion is not only immoral but has caused hundreds of thousands of deaths due to delayed availability of effective drugs. It is understandable that consumers would want some indication that the drugs or treatments they are receiving are not going to cause more harm than good. However, supplying consumers with this information via FDA regulation in no way requires bestowing the FDA with coercive power.

When regulatory agencies possess coercive power, market incentives and consumer satisfaction are destroyed.

Determining if the lives saved by preventing bad drugs from entering the market outweigh the number of lives lost by preventing or delaying good drugs from being developed frames the issue from the wrong perspective.

The existence of the FDA and a free market of medical treatments are not mutually exclusive. In fact, the presence of regulatory agencies to provide consumers with quality assurance information is a desirable part of the market. However, it is when these regulatory agencies possess coercive power that market incentives and consumer satisfaction are destroyed. (One might even prefer that regulatory agencies be private institutions, but let’s take one step at a time.)

Let’s see how this arrangement would work out best for everyone. If an individual was a strong proponent of the FDA because it made them feel safer when buying pharmaceuticals, they could still enjoy these benefits without coercion by the FDA. They could simply resolve to buy only pharmaceuticals that were branded with FDA approval.

However, let’s say a patient is either desperate for a non-FDA approved, possibly life-saving drug, or they simply prefer the good track record of a drug to the FDA’s approval. Not only could they exercise their individual preferences, but they could also save money by buying non-FDA-approved drugs. This is because FDA-approved drugs would likely be costlier than non-FDA-approved drugs. Some percentage of the consumer base will value the quality assurance offered by FDA approval more than the cost of having it, increasing the price they would be willing to pay for FDA-approved drugs.

Equity, Incentives, and Low-Income Access to Drugs

Critics might argue that this would exacerbate inequities between the people able to afford FDA-approved drugs and people only able to afford non-FDA approved drugs. However, all drugs currently require FDA approval, so access to effective treatments by low-income groups could only improve with the introduction of non-FDA-approved pharmaceuticals. Additionally, FDA-approved drugs could only be more expensive than the non-FDA-approved drugs to the extent that consumers value their safety more than their money.

With the FDA-approval hurdle removed, pharmaceutical companies will have greater incentives to innovate.

Additionally, by not requiring FDA-approval for drugs before they enter the market, this provides incentives for pharmaceutical companies to engage in the research and development (R&D) process in the first place. If the risk of investment outweighs projected profits due to FDA approval and R&D costs, then a company probably won’t embark on the R&D journey to begin with. However, with the FDA-approval hurdle removed, the risks decrease and pharmaceutical companies will have a greater incentive to innovate.

Current drug prices are artificially high because the FDA approval process disincentivizes research and development and prevents new or already developed drugs from competing with existing FDA-approved drugs. With increased innovation and decreased barriers, the market will saturate and prices will decrease.

Free Markets Always Provide More Options

What if pharmaceutical companies, only concerned with saving money and maximizing profits, never choose to get FDA approval? This would only happen if consumers do not value the FDA’s validation of those specific drugs in the first place. The only buffer to this effect would be the time it takes to be approved by the FDA. Thus, only after the market for a specific FDA-approved drug is saturated would pharmaceutical companies have a cost-saving incentive to not become FDA-approved.

One could argue that getting rid of the FDA completely might harm some people by restricting consumer information, yet merely taking away the coercive power of the FDA still allows consumers to make fully-informed, and free, decisions. There is so much political rhetoric floating around about the War on Drugs, but, ironically, we seem to not recognize that there are actually two Wars on Drugs. Both inherently infringe on our property rights to our own bodies via government coercion.

I want to end with one of my favorite quotes from Milton Friedman, “I have no right to coerce someone else, because I cannot be sure that I’m right and he [or she] is wrong.”

  • Jordan is a 3rd-Year Biochemistry and Cell Biology Major at the University of California, San Diego.