Compared to much of the world, Americans have far less access to common drugs that many people in the world can buy over the counter. At the Cato Institute, Jeffrey A. Singer and Bautista Vivanco discuss the situation, writing:
Earlier this month, STAT News published an opinion piece we wrote about the drug domperidone, an anti-nausea medication that may also help with breastfeeding. It is available by prescription in Australia, Canada, the UK, and several European Union countries, over the counter in China, Italy, Mexico, New Zealand, and South Africa, and either OTC or by prescription in at least 58 countries—but only horses can obtain it in the US. Americans can drive across our northern or southern borders if they wish to access domperidone. Canadians have been able to access domperidone since 1993.
This led us to ask: what other drugs does the Food and Drug Administration (FDA) block patients and doctors from accessing that Canadian patients and doctors can get? To address the question, we compared the contents of the American Drugs@FDA database and the Canadian Drug Product Database. These government-run databases provide the most current information on the approval status of most drug products in these two countries. We identified 69 drugs that have received market approval in Canada but not in the US.
One is benserazide, which is paired with levodopa to treat Parkinson’s Disease. Benserazide is on the World Health Organization (WHO) list of essential medicines. The European Medicines Agency designated it an “orphan drug” due to its potential to treat the blood disease beta-thalassemia. The FDA blocks Americans from accessing the drug, even though it has been widely used for decades—since 1977 in Canada—because its manufacturer, Roche, chose not to incur the costs of the clinical safety and efficacy trials the FDA would require.
Another is raltitrexed (Tomudex), which Canadians have been able to access since 1996. Oncologists use the chemotherapeutic agent 5‑fluorouracil (5‑FU) as adjuvant (post-surgical) therapy for patients with colorectal cancer or to palliate patients with advanced disease. Because it is equally effective, doctors in Canada and many European countries substitute raltitrexed for 5‑FU in patients who develop 5‑FU toxicity, which can involve the heart and the mucous membranes. The FDA expects comprehensive clinical trial data involving US or multi-regional patient populations to evaluate safety and efficacy. Historically, most raltitrexed studies were carried out in Europe. Once again, there is little motivation for AstraZeneca, the manufacturer of the drug, to incur the costs. Fortunately, the FDA removed restrictions, allowing Americans to access the drug capecitabine (Xeloda) as an alternative to 5‑FU for adjuvant therapy. However, the body metabolizes capecitabine into 5‑FU, making it a less effective substitute for patients with 5‑FU toxicity.
Read more here.
