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The Goodman Institute Health Blog

What Is a Drug? Philosopher Struggles but the FDA Has its Own Definition

Posted on November 20, 2023 by Devon Herrick

Drugs are the most efficient of all medical therapies, representing only about 8.8% of national health expenditures. By contrast, at $864.6 billion in 2021, Americans spent more than twice as much on physician care and 3.5 times as much on hospital care. Over-the-counter (OTC) drugs are especially economical, most of which were once prescription drugs. OTC drugs represent between 1% and 2% of medical spending.

Most physician visits are probably to access prescription drugs. Often times we already know what we need but still have to see our doctors once or twice a year authorize refills. Drugs even reduce the need for inpatient care, keeping patients out of the hospital.

Writing in The Conversation, Sam Baron, an associate professor of the philosophy of science asks, “how can you define a drug?” or “What’s a medical drug?” Baron and his colleagues published a recent article in the Journal of Medicine and Philosophy asking that academic question. Baron says that if you ask a random person those questions, they will likely tell you, “it’s the kind of thing you take when you’re unwell.” Baron disagrees, but confesses he said he and his colleagues were hard pressed to find a better definition. If drugs are to make you feel better, chocolate, comfort foods and a cold drink on a hot day also make you feel better. Baron says:

Despite their centrality to medicine, we have no idea what medical drugs are. We can’t even tell the difference between drugs and food, let alone drugs and so-called “natural” alternatives.

A definition should also be narrow enough to exclude substances not typically considered drugs. Take food, for example. Eating a sandwich is usually never thought of as taking a drug.

Baron points to the Canadian Institutes for Health Research, which compiled a drug bank with 16,000 substances. A distinction must be made between natural elixirs like fish oil and inert ones like placebos. Placebos (sometimes called sugar pills) can elicit a drug-like effect. Indeed, in my opinion some actual drugs are mostly ineffective and only work due to the placebo effect. By the way, research has found that expensive placebos work better than cheap ones.

Drugs are highly regulated across the developed world. As such the regulatory bodies must have legal definitions of the substances under their purview. Baron and his colleagues could have saved a lot of effort if they had simply asked the FDA, which has specific criteria for the legal definition of a drug. First of all, drugs are (A), substances currently recognized as drugs. But how does something become a drug? According to the FDA:

(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals.

These distinctions are important for legal reasons. Let’s say you’re a botanist and you discover an obscure plant that has Viagra-like properties and you want to sell it as a natural, dietary supplement. Maybe you discover that red rice yeast lowers blood pressure, because it contains a natural form of the hypertension drug, Lovastatin. Perhaps it’s already a drug in another country like Phenibut is in Russia, and you want to sell it as a dietary supplement in the US. You can’t because the FDA takes a dim view of that. The government prosecutes companies it believes are engaged in selling drug products as dietary supplements. The drug agency also takes legal action against companies’ unsubstantiated health claims. If you substantiate your health claims it becomes an (unapproved) drug under Section 201(g) of the Food, Drug & Cosmetic Act (21 USC 321(g)).

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For many years, our health care blog was the only free enterprise health policy blog on the internet. Then, when the NCPA closed its doors, the health blog stopped as well.

During this five-year hiatus no one else has come forward to claim the space. So, my colleagues and I have decided to restart the blog in connection with the Goodman Institute. We invite you and others to use this forum to share your views.

John C. Goodman,

Visit www.goodmaninstitute.org

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