Domperidone is an important medication used primarily to treat nausea and to stimulate a sluggish gastrointestinal tract. Clinicians consider it the “gold standard” for treating gastrointestinal symptoms in Parkinson’s patients because it has fewer side effects in them than other drugs. It even helps with breastfeeding.
Sadly, in America, you can’t get your hands (or hooves) on it unless you are a quadruped. The Food and Drug Administration will only let you receive it if you are a horse suffering from fescue toxicosis, a grass fungus infection.
Yet human patients in New Zealand have obtained the drug over the counter since 2016. It is also available over the counter (OTC) in many countries, including Chile, China, Ireland, Italy, Mexico, the Netherlands, and South Africa. People in 58 countries can obtain domperidone either OTC or by prescription.
Jack Newman of the International Breastfeeding Centre in Ontario, Canada, called it a “shame … for women in the U.S. to be deprived of this drug” to enhance lactation.
But domperidone is not the only drug the U.S. government blocks women from obtaining.
Women can obtain over-the-counter birth control pills in more than 100 countries. In 2023, the FDA made one brand of oral contraceptive OTC. Unfortunately, it’s a “minipill” (meaning that it does not contain estrogen), which many women find impractical or inconvenient, because of its strict same-time daily schedule. So far, only about 3% of women aged 18 to 49 have used the contraceptive since it became available OTC.
Meanwhile, in Italy, adults have had access to the overdose antidote naloxone OTC (in both injectable and nasal spray forms) since 1996; it has been available in Australia since 2016. The FDA didn’t unblock OTC naloxone nasal spray until 2023. Adults can purchase simvastatin (a statin) OTC in the U.K. and New Zealand. They can access insulin products, including analogs like Lantus, Humalog, and Levemir, OTC in Canada and Mexico. But in the U.S., only the original regular and NPH insulin are available without a prescription. Migraine drug sumatriptan (Imitrex) is OTC in the U.K., Germany, and Sweden, but not here. Australians can buy OTC albuterol asthma inhalers, but they need a prescription in the U.S.
More than a century ago, the great jurist Benjamin Cardozo wrote, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.” That principle anchors modern medical ethics, taught from day one in medical school: respect for patients’ autonomy. The right to self-medicate flows directly from that idea.
The right to self-medicate implies that individuals likewise have a right to ingest whatever medicines and use whatever medical treatments they choose, even if doing so will harm them. In “Your Body, Your Health Care,” a new book from the Cato Institute written by one of us (Singer), I argue that while medical ethics uphold autonomy, government policy violates it daily — especially by restricting access to medications it hasn’t approved.
The 1938 Food, Drug, and Cosmetic Act barred patients from obtaining medicines directly from manufacturers without government approval. Until 1951, manufacturers decided whether to sell a drug over the counter or only to consumers with a provider’s prescription, typically weighing liability and reputation. Then Congress took that decision away from manufacturers and gave the FDA sole authority, undermining both patient and manufacturer autonomy. It also opened the door to politics and special interest lobbying, which helps explain why U.S. women still have access to only one brand of one kind of birth control pill OTC, and why it took 14 years and a court order for them to get emergency contraception.
To move toward restoring autonomy, Congress should enact reciprocal approval for drugs and medical devices cleared by comparable countries. The CE mark, for example (from the French term “conformité européenne,” translated as “European conformity”), indicates that a product meets European Union safety standards. E.U. member states Iceland, Liechtenstein, and Norway already recognize one another’s approvals. Since 2018, Australia has allowed access to FDA-approved medical devices, and E.U.-authorized ones for even longer. Israel permits its residents to utilize drugs and devices approved by the governments of the United States, European Union, Australia, and Canada.
Americans deserve the same access.
Some may question whether it is safe for the government to permit access to medications approved by regulatory agencies in comparator countries but not approved by the FDA. After all, the FDA didn’t approve thalidomide because it was not convinced of its safety, while European drug agencies gave it the green light. The wave of horrific birth defects that followed vindicated the FDA’s decision.
However, the FDA has approved numerous drugs that it later removed from the market when they proved unsafe. When Merck’s research indicated that its FDA-approved nonsteroidal anti-inflammatory drug, Vioxx (rofecoxib), increased the risk of heart attack and stroke, it pulled the drug from the market to mitigate liability and protect its reputation. The FDA never rescinded its approval; it merely issued a risk advisory.
The point is that no regulatory agency will get things right all the time. However, when regulatory agencies compete with their counterparts in other countries, it motivates excellence and, more importantly, provides patients with options. Ultimately, patients have the right to make their own choices. It’s their body and their health care.
Too often, the U.S. government blocks access to safe, effective treatments that people and horses elsewhere use freely. If adults around the world can access safe, effective medicines without a doctor’s permission, Americans should also be able to. No one should have to suffer needlessly or fight bureaucracy just to feel better. Respecting autonomy means trusting people to care for their own bodies.
Jeffrey A. Singer, M.D., practices general surgery in Phoenix, is a senior fellow at the Cato Institute, and is the author of the book “Your Body, Your Health Care,” published by the Cato Institute. Bautista Vivanco is a health policy research associate at the Cato Institute.
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