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.
“This is the first time the FDA has proactively developed and tested a DFL for a drug to support development of an OTC product,” Gottlieb’s statement continued. “The FDA team sought input from multiple stakeholders in the addiction care community, as well as from the FDA internal experts, to streamline the DFL to contain only the most critical information, so that it could be easily understood in an emergency.”
While “one of the key components for OTC availability is now in place,” drug companies will still have to insert any product-specific information and, in some cases, may need to conduct additional comprehension testing.
“I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with applications as soon as possible,” Gottlieb’s statement went on. “This work builds on our ongoing efforts to get this life-saving drug into the hands of those who need it most. … We’re taking many steps to improve availability of naloxone products and we’re committed to working with other federal, state and local officials; health care providers; patients; and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction.”