Opioid Crisis: FDA Clears Life-Saving Drug for Over-the-Counter Sales

On Thursday, January 17th, the Food and Drug Administration (FDA) announced it was taking unprecedented steps to encourage drug companies to develop over-the-counter (OTC) versions of the overdose antidote naloxone in an effort to increase access and cut costs for consumers in hopes of reducing opioid deaths.

“FDA-approved versions of naloxone currently require a prescription, which may be a barrier for people who aren’t under the care of a physician or may be ashamed or even fearful of admitting to issues with substance abuse,” FDA Commissioner Scott Gottlieb said in a statement on the agency’s website. “Having naloxone widely available, for example as an approved OTC product, is an important public health advance, and a need that we’ve been working on at the FDA.”

Before companies can apply to sell any drug over-the-counter, they must develop a consumer-friendly Drug Fact labels (DFL) and conduct studies which demonstrate that the drug can be used without a doctor’s supervision. Recognizing that these requirements are “a barrier to development of OTC naloxone products,” the FDA created and tested two model DFLs “with easy-to-understand pictograms” — one for a nasal spray and one for an auto-injector — that drug companies can use when they apply for permission to sell naloxone without a prescription.

Read Full Article