{"id":46034,"date":"2025-08-05T19:26:09","date_gmt":"2025-08-05T19:26:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/au\/46034\/"},"modified":"2025-08-05T19:26:09","modified_gmt":"2025-08-05T19:26:09","slug":"its-past-time-for-the-u-s-to-embrace-reciprocal-drug-approval","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/au\/46034\/","title":{"rendered":"It\u2019s past time for the U.S. to embrace reciprocal drug approval"},"content":{"rendered":"

Domperidone is an important\u00a0medication<\/a>\u00a0used primarily to treat nausea and to stimulate a sluggish gastrointestinal tract. Clinicians consider it the \u201cgold standard<\/a>\u201d for treating gastrointestinal symptoms in Parkinson\u2019s patients because it has fewer side effects in them than other drugs. It even helps with breastfeeding.<\/p>\n

Sadly, in America, you can\u2019t 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.<\/p>\n

Yet human patients in\u00a0New Zealand<\/a>\u00a0have obtained the drug over the counter since 2016. It is also available\u00a0over the counter (OTC) in many countries<\/a>, including Chile, China, Ireland, Italy, Mexico, the Netherlands, and South Africa. People in\u00a058 countries<\/a>\u00a0can obtain domperidone either OTC or by prescription.<\/p>\n

Jack Newman of the\u00a0International Breastfeeding Centre<\/a>\u00a0in Ontario, Canada, called it a \u201cshame \u2026 for women in the U.S. to be deprived of this drug\u201d to enhance lactation.<\/p>\n

But domperidone is not the only drug the U.S. government blocks women from obtaining.<\/p>\n

\t\t\t\"\"\t\t<\/p>\n

\t\t\t\t\t\tThe time has come for over-the-counter antidepressants<\/a><\/p>\n

Women can obtain over-the-counter birth control pills in more than\u00a0100 countries<\/a>. In 2023, the FDA made one brand of oral contraceptive OTC<\/a>. Unfortunately, it\u2019s a \u201cminipill\u201d (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%<\/a> of women aged 18 to 49 have used the contraceptive since it became available OTC.<\/p>\n

Meanwhile, in\u00a0Italy<\/a>, adults have had access to the overdose antidote naloxone OTC (in both injectable and nasal spray forms) since 1996; it has been available in\u00a0Australia<\/a>\u00a0since 2016. The FDA didn\u2019t\u00a0unblock<\/a>\u00a0OTC naloxone nasal spray until 2023. Adults can purchase simvastatin (a statin) OTC in the\u00a0U.K.<\/a>\u00a0and\u00a0New Zealand<\/a>. They can access insulin products, including analogs like Lantus, Humalog, and Levemir, OTC in\u00a0Canada<\/a>\u00a0and\u00a0Mexico<\/a>. But in the U.S.,\u00a0only the original\u00a0regular and NPH insulin<\/a>\u00a0are available without a prescription. Migraine drug sumatriptan (Imitrex) is OTC in the\u00a0U.K.<\/a>,\u00a0Germany<\/a>, and\u00a0Sweden<\/a>, but not here.\u00a0Australians<\/a>\u00a0can buy OTC albuterol asthma inhalers, but they need a prescription in the U.S.<\/p>\n

More than a century ago, the great jurist Benjamin Cardozo wrote<\/a>, \u201cEvery human being of adult years and sound mind has a right to determine what shall be done with his own body.\u201d\u00a0That principle anchors modern medical ethics, taught from day one in medical school: respect for patients\u2019 autonomy. The right to self-medicate flows directly from that idea.<\/p>\n

The right to self-medicate implies that individuals likewise have a\u00a0right to ingest whatever medicines and use whatever medical treatments they choose, even if doing so will harm them. In\u00a0\u201cYour Body, Your Health Care<\/a>,\u201d a new book from the Cato Institute written by one of us (Singer), I argue that while\u00a0medical ethics uphold autonomy, government policy violates it daily \u2014 especially by restricting access to medications it hasn\u2019t approved.<\/p>\n

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\u2019s prescription, typically weighing liability and reputation. Then Congress took that decision away from manufacturers and gave the FDA sole authority<\/a>, 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\u00a0only one brand of one kind of birth control pill<\/a> OTC, and why it took\u00a014 years and a court order<\/a>\u00a0for them to get emergency contraception.<\/p>\n

To move toward restoring autonomy,\u00a0Congress should enact\u00a0reciprocal approval<\/a>\u00a0for drugs and medical devices cleared by comparable countries. The CE mark, for example (from the French term\u00a0\u201cconformit\u00e9 europ\u00e9enne,\u201d translated as \u201cEuropean conformity\u201d), indicates that a product meets\u00a0European Union safety standards<\/a>. E.U. member states Iceland, Liechtenstein, and Norway already recognize one another\u2019s approvals. Since 2018,\u00a0Australia<\/a>\u00a0has allowed access to FDA-approved medical devices, and E.U.-authorized ones for even longer.\u00a0Israel<\/a>\u00a0permits its residents to utilize drugs and devices approved by the governments of the\u00a0United States, European Union, Australia, and Canada<\/a>.<\/p>\n

Americans deserve the same access.<\/p>\n

\t\t\t\"\"\t\t<\/p>\n

\t\t\t\t\"\"\/
\n\t\t\t\tThere\u2019s a better way to get drugs on the market: progressive approval<\/a><\/p>\n

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\u2019t approve thalidomide because it was not convinced of its safety, while European drug agencies gave it the green light. The wave of\u00a0horrific birth defects<\/a>\u00a0that followed vindicated the FDA\u2019s decision.<\/p>\n

However, the FDA has approved\u00a0numerous drug<\/a>s that it later removed from the market when they proved unsafe. When Merck\u2019s 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\u00a0risk advisory<\/a>.\u00a0\u00a0<\/p>\n

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\u2019s their body and their health care.<\/p>\n

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\u2019s 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.<\/p>\n

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 \u201cYour Body, Your Health Care<\/a>,\u201d published by the Cato Institute. Bautista Vivanco is a health policy research associate at the Cato Institute.<\/p>\n","protected":false},"excerpt":{"rendered":"Domperidone is an important\u00a0medication\u00a0used primarily to treat nausea and to stimulate a sluggish gastrointestinal tract. Clinicians consider it…\n","protected":false},"author":2,"featured_media":46035,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[64,63,2156,137,490,4334,10839],"class_list":{"0":"post-46034","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-au","9":"tag-australia","10":"tag-fda","11":"tag-health","12":"tag-medication","13":"tag-pharmaceuticals","14":"tag-policy"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/46034","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=46034"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/46034\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/46035"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=46034"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=46034"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=46034"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}