FDA Takes Another Swing at OTC Naloxone Pitch

Jeffrey A. SingerAs I have beenwriting for years, the Food and Drug Administration should reclassify the opioid overdose antidote naloxone, approved for use in 1971 and used by non ‐​physicians, including first responders, to rescue overdose victims for the past few decades, as an over‐​the‐​counter drug. The drug has been available OTC inAustralia since 2015 and inItaly for more than 20 years.Moreover,all 50 states have come up with ways to work around the prescription ‐​only status of the drug—either by allowing state health directors and other licensed practitioners to issue standing orders to pharmacists to dispense the medication to requesting customers—or by authorizing pharmacists to prescribe the drug. There is thus ample evidence that non‐​phys icians can and do safely and appropriately use naloxone. As annual overdose deaths exceed 100,000, I cannot overstate the value of making this drug widely and readily available.The FDA has repeatedly encouraged naloxone manufacturers to request that the agency start reclassifying naloxone as an OTC drug. In 2019, then FDA ‐​Commissioner Scott Gottlieb went so far as to havethe agency design the Drug Facts Labels (DFL) required for drug makers to sell their products over the counter and even tested these labels for “consumer comprehension” in front of focus groups—a job usually required from manufacturers who request reclassifying their drugs as OTC. The Commissioner stated in th...
Source: Cato-at-liberty - Category: American Health Authors: Source Type: blogs