FDA advisers to consider OTC Narcan

From: POLITICO's Prescription Pulse - Tuesday Feb 14,2023 05:01 pm
Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
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By Katherine Ellen Foley and David Lim

Driving the Day

A jeep bumper shows a sticker with the slogan 'Yes We Narcan.'

The manufacturer of Narcan has asked the FDA to allow it to sell the drug over the counter. | Brynn Anderson/AP Photo

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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Around the Agencies

MEDCAC WEIGHS AHRQ REPORTCMS convened its Medicare Evidence Development and Coverage Advisory Committee for a two-day meeting on Monday to discuss the criteria for studies submitted to the agency for products under coverage with evidence development.

The outside panel is slated to vote today on proposed revisions, recommended by the Agency for Healthcare Research and Quality’s evidence-based practice program, intended to ensure data from such studies can be used to determine whether a medical product is reasonable and necessary.

The Department of Health and Human Services building is pictured. | AP Photo

HHS has chosen six companies to help it develop a nationwide network to share electronic health records. | Alex Brandon/AP Photo

A MOVE ON DATA SHARING On Monday, HHS said it had selected six companies and organizations to facilitate the sharing of patients’ health care data, POLITICO’s Ben Leonard and Ruth Reader report. The move is a major step in the rollout of what the department foresees as a nationwide system — though it could be a year for the companies to go through a mandated preproduction testing process and project planning.

The six companies bring a variety of expertise to the table and include:

— Epic, an electronic health records firm

— CommonWell Health Alliance, a data-sharing trade group

— Health Gorilla, an interoperability platform

— Kno2, an interoperability platform

— eHealth Exchange, a health information network

— KONZA National Network, a nonprofit that supports health information exchanges

 

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MEDICAL DEVICES

FIRST POINT-OF-CARE MPOX TEST — The FDA authorized emergency use of the first point-of-care mpox test Friday, adding a tool to the United States’ arsenal if the virus makes a resurgence.

The test, made by Cepheid, is a real-time polymerase chain-reaction diagnostic that detects virus from specimens swabbed from lesions on patients suspected of having mpox by their health care providers.

Coronavirus

GOVERNMENT BUYS MORE NOVAVAXNovavax said Monday the U.S. government agreed to extend a contract to purchase up to an additional 1.5 million doses of its Covid-19 vaccine. The company said the extension will help support the development of smaller vials and future strain selection.

The company declined to comment on the overall agreement’s cost. “We look forward to continuing our collaboration with the U.S. government on the development of our COVID-19 vaccine to meet the requirements of the FDA and our commercial customers for the upcoming 2023/2024 vaccination campaign,” Novavax CEO John Jacobs said in a press release.

In the Courts

NO DEFENSE ON N.C. ABORTION PILL RULES — North Carolina Attorney General Josh Stein said Monday he will not defend his state’s restrictions on abortion pills — responding to a lawsuit from a doctor who says they harm her ability to serve her patients and clash with federal rules that allow the pills to be obtained via telemedicine, mail delivery and local pharmacies, POLITICO’s Alice Miranda Ollstein reports.

Pharma Worldwide

GAVI NAMES NEW CEO — Muhammad Ali Pate, a former junior Nigerian health minister and senior World Bank official, will be the next CEO of Gavi, the Vaccine Alliance.

Pharma Moves

House Appropriations Committee ranking member Rosa DeLauro (D-Conn.) announced that staff director Robin Juliano will depart in early March and be replaced by Chris Bigelow.

President Joe Biden renominated Rebecca Kelly Slaughter to a second term as one of five Federal Trade Commissioners. She will need to be reconfirmed by the Senate.

Sanofi announced Monday that John Reed, its global head of research and development, is leaving the company. His new employer, Johnson & Johnson, said he will start as the company’s executive vice president of pharmaceuticals research and development in April. Dietmar Berger will fill his former position at Sanofi on an interim basis while the company conducts a replacement search.

Quick Hits

GOP officials in states with near-total abortion bans are at odds with local district attorneys who won’t enforce them, POLITICO’s Alice Miranda Ollstein and Megan Messerly report.

Xylazine, a tranquilizer authorized only for animals, is making the U.S.’ fentanyl crisis worse, The Wall Street Journal’s Jon Kamp and Julie Wernau report.

Document Drawer

The FDA published draft guidance on Friday for drug developers determining what type of long-term neurologic, sensory and developmental evaluations might help support a medical product application for infants.

 

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