SHOULD NARCAN GO OVER THE COUNTER? On Wednesday, expert advisers to the FDA will consider whether the agency should greenlight an over-the-counter version of an inhaled opioid overdose antidote. Emergent BioSolutions — the company that manufactures the naloxone nasal spray Narcan — asked the FDA for its product to be sold without a prescription in December, shortly after the agency signaled it would consider Narcan and auto-injected naloxone for OTC use. If approved later this year, it would be the first time the 50-year-old drug would be accessible in a drugstore without going through a health care provider. Clearing the path for a nonprescription overdose antidote has been a priority of the Biden administration as it tackles the opioid epidemic, especially the fentanyl crisis. Opioid overdoses killed nearly 81,000 people in 2021, and the Centers for Disease Control and Prevention estimates that, in many cases, someone could have intervened. Naloxone used as an anti-overdose drug has no adverse side effects nor is it addictive, and it will not harm a person who is overdosing from a drug other than an opioid. Many public health experts agree that removing barriers to accessing the lifesaving drug, and Washington Analysis, a group that evaluates possible economic and regulatory decisions, believes the FDA’s advisers will endorse stripping Narcan of its prescription status. But still, the agency is wary that the general public might have difficulty using Narcan correctly on their own. Meeting materials prepared by the FDA outline several concerns that the agency has about the data Emergent BioSolutions submitted demonstrating that lay people could successfully use its product — and that many study participants called emergency services before administering Narcan, a move that could delay naloxone’s administration. The FDA also expressed concern that not enough people with limited literacy participated in the study, meaning there weren’t enough participants with literacy issues to know whether all potential users could understand the instructions. As a result, the agency is asking advisers to discuss whether Emergent may need to provide additional data to the FDA before it approves the drug’s OTC status. “I’m not against them investigating OTC status,” Sarah Evans, the division director of drug policy at Open Society Foundations, a grantmaking network founded by George Soros, told Prescription Pulse. But, she added, an enormous amount of real-world data shows that lay people can use naloxone in all its forms — including as an injected drug, which is the most common — with minimal training. Using a nasal spray is even easier than administering an injection. “There’s years and years of experience,” Evans said. “That experience isn’t a controlled scientific study; it’s just literally hundreds of thousands of overdose reversals … it should count for something.” What’s next: The FDA is slated to decide whether to approve nasal spray Narcan for OTC use by March 29. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Overheard at the Biopharma Congress in Washington, D.C., yesterday: FDA Commissioner Robert Califf said that advisory committee meetings are often “too compressed” to carry out full discussions of a therapy under consideration and don’t exist to produce “gladiator votes.” Send news, tips and the best health policy Valentines to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Ruth Reader about HHS' new pilot program that aims to help patients access their health data more easily.
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