As I have been writing 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 for the past few decades overdose victims, as an over‐the‐counter drug. The drug has been available OTC in Australia since 2015 and in Italy 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‐physicians 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 have the 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 the announcement that it is an unprecedented effort to facilitate and speed up the reclassification of naloxone from prescription‐only to OTC.
Today the FDA issued a notice in the Federal Register that the agency’s “preliminary assessment” is that “certain naloxone products have the potential to be safe and effective for over‐the‐counter use.” An agency press release stated:
The Federal Register notice includes a preliminary assessment that certain naloxone drug products–up to 4 milligrams (mg) nasal spray and up to 2 mg autoinjector for intramuscular (IM) or subcutaneous (SC) use–may be approvable as safe and effective for nonprescription use. This preliminary assessment is intended to facilitate development and approval of nonprescription naloxone products; however, it is not a final determination that certain naloxone drug products are safe and effective for nonprescription use, and it does not mandate an immediately effective switch to nonprescription/over‐the‐counter (OTC) availability for naloxone.
As I have pointed out previously, the FDA doesn’t need to wait for the drug makers to request reclassifying a drug as OTC. Under FDA regulations, the FDA can undertake a reclassification review at the request of “any interested person” or the Commissioner himself. States may petition the FDA for reclassification. Finally, if all else fails, Congress can order the reclassification.
Manufacturers often have little incentive to submit or support OTC petitions and every reason to oppose them, because removing prescription requirements for their or their competitors’ products brings greater price competition and reduced profits. The FDA’s policy of waiting for manufacturers to initiate prescription‐to‐OTC switches therefore rigs the process against consumers. If the power to require prescriptions remains with the FDA, the agency should initiate switches itself and abandon its historical practice of waiting for the manufacturers to petition the agency to switch their products.
The FDA’s Federal Register notice today is just another ill‐fated attempt to prod naloxone manufacturers into asking the agency to start the OTC reclassification process. Congress should respond to FDA fecklessness by imposing a deadline for the agency to make naloxone OTC.