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

Naloxone, which can reverse opioid overdoses, has already saved thousands of lives

ROCKFORD, IL - JULY 14:  A Rockford firefighter displays a dose of Naloxone which the department carries on their ambulances to treat opioid drug overdoses on July 14, 2017 in Rockford, Illinois. Rockford, a city of about 150,000 located in northern Illinois, averages about 2 overdose deaths per week, the majority of which are heroin related. Nationwide, an estimated 60,000 people in the U.S. died from drug overdoses in 2016, more than gunshots or traffic accidents.   (Photo by Scott Olson/Getty Images)

A Rockford firefighter displays a dose of Naloxone which the department carries on their ambulances to treat opioid drug overdoses on July 14, 2017 in Rockford, Illinois.

Scott Olson/Getty Images

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-injectorthat 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.”

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