It's been six years since a startling story in The New York Times detailed how fatal opioid overdoses were tearing through rural regions of the United States "like a plow through soil." The report came as the nation was beginning to grasp that it faced the deadliest wave of drug use in U.S. history — and not just in struggling Rust Belt areas. Fatal overdoses of prescription and illicit opioids went from 21,089 in 2010 to 42,249 in 2016 to 107,622 in 2021. In 2018, aware that public health strategies were failing, Surgeon General Jerome Adams took the unprecedented step of saying that naloxone — a powerful prescription drug that quickly reverses opioid overdoses — should become ubiquitous in everyday life, carried both by addicts and their acquaintances, and that its cost must not be allowed to inhibit its broad use.
His first recommendation soon became so accepted that naloxone is now kept not just by first responders but by librarians. But it is only of late that the U.S. Food and Drug Administration has moved to realize Adams' goal of making naloxone both less expensive and more accessible. On Nov. 15, after years of review, the agency announced that it had concluded that "certain naloxone products have the potential to be safe and effective" as over-the-counter drugs, which have uniform prices and are much cheaper and less subject to regulation than prescription drugs under the complex system in place in the U.S. Then, the day after Christmas, The Wall Street Journal reported that Harm Reduction Therapeutics — a pharmaceutical nonprofit — could win final FDA approval by late April for a naloxone nasal spray that would cost about $18 a dose. That would be less than 10% of the typical cost for the drug paid by those without health insurance. A RAND study last year found such a price breakthrough was key to limiting overdose deaths.
The drug approval process should not be precipitous, but that concern doesn't apply here. The FDA gave its blessing to naloxone's use as a treatment for overdoses in 1971. Its efficacy was documented long before the opioid epidemic began. It's not hyperbole to say that tens of thousands of Americans would still be alive if only bureaucrats had figured out — as the surgeon general did in 2018 — that in this case, caution was actually reckless.
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