One can desire lower-cost access to drugs while being troubled by President Trump's executive order (EO) last week. Critics argue that the EO imports bad policies that are in effect in the rest of the world and would reduce the pharmaceutical industry’s investment in life saving drugs.
There is an alternative though, that would accomplish the same goal without government intervention. Dr. Jefferey A. Singer’s recent book Your Body, Hour Health Care shows how changes in U.S. pharmaceutical regulation could dramatically bring down the costs of prescription drugs and make Americans healthier. Singer starts from a very simple premise that is difficult to argue with; all legal aged adults have the right to determine what should be done with their bodies. Also known as the right to medical self-determination.
With exceptions for emergency circumstances, Singer points out that medical self-determination is the corollary to the doctrine of informed consent. Informed consent is enshrined in our healthcare system through various Federal and State laws and court decisions and means that we all have the right to know what the purpose of a proposed treatment is, what results we can expect and be made aware of potential risks. Like informed consent, the right to medical self-determination is based upon the fact that only an individual adult can weigh his or her own costs and benefits.
Do we really get to determine what kind of medical treatment we get? Do we have the medical right to self-determination? Not really. While we have a right to say “no” to a doctor, the U.S. Food and Drug Administration (FDA) greatly limits what we can say “yes” to. All drugs and treatments that a doctor suggests must first be approved by the FDA and the FDA prevents adults from obtaining many drugs without a prescription. Naturally, all of this raises consumer costs.
It is an article of faith among many that our current system for developing and approving new drugs and medical procedures is designed to be innovative and cutting edge, bringing optimal medicine and healthcare for the dollars that we invest. American pharmaceutical companies spend around $100 billion each year on research and development spending. In 2023 the federal government spent almost $48 billion for medical research, mostly through the National Institutes of Health (NIH).
While $100 billion is a lot of private money, it typically costs $1 billion or more to develop a new drug and get it through the FDA approval process. Likewise, $48 billion is a lot of Federal research money. But, FDA administrator Dr. Marty Makary pointed out in his book Blind Spots, the NIH spends around $8 billion per year on cancer research, with very little to show for it. In his estimation, this is because the medical establishment has a “culture of obedience” that allows entrenched scientists to limit discussion and stifle scientific debate. Obviously, this culture of obedience leads us to massive spending, little real innovation and poor bang for our buck when it comes to new medical treatments.
So, we have a private sector that is constrained by FDA regulations and a public sector that is suboptimized by a medical research establishment that lacks real intellectual curiosity. It seems that a dose of competition is in order, competition that would come from loosening the FDA’s grip on drug approval and allowing adults true medical self-determination.
How could doctors and the public possibly determine, without the FDA’s guidance, if a drug is effective and safe? Singer makes the case that drug review was and continues to be performed by private organizations. The U.S. Pharmacopeial Convention was founded in 1820 and is a science-based organization that sets standards for medicines and dietary supplements. The American Medical Association and Consumer Reports also supply review services. Insurance companies very much have an interest in drug safety and efficacy. These are all private options that come without the $1.0+ billion price tag attached to FDA approval.
Allowing American adults the right to medical self-determination would bring true innovation to the market for pharmaceutical drugs and bring consumer costs down without government intervention. Rather than more government intervention, let’s try less.
