Narcan Moves Closer To Being Sold Over The Counter
Two panels of addiction experts recommended Wednesday that the FDA allow naloxone, an overdose-reversing nasal spray, to be sold without a prescription. Doctors and other advocacy groups have also pressed the Biden administration to make such a move to combat the opioid epidemic.
The New York Times:
Narcan Is Safe To Sell Over The Counter, Advisers To The FDA Conclude
Two federal panels of addiction experts on Wednesday unanimously recommended that Narcan, the overdose-reversing nasal spray, be made widely available without a prescription, a significant step in the effort to stem skyrocketing drug fatalities. Making Narcan an over-the-counter drug has been urged by doctors, patient advocacy groups and the Biden administration. (Hoffman, 2/15)
AP:
Panel Backs Moving Opioid Antidote Narcan Over The Counter
The positive vote, which is not binding, came despite concerns from some panel members about the drug’s instructions and packaging, which caused confusion among some people in a company study. The manufacturer, Emergent Biosolutions, said it would revise the packaging and labeling to address those concerns. The FDA will make a final decision on the drug in coming weeks. Panel members urged the FDA to move swiftly rather than waiting for Emergent to conduct a follow-up study with the easier-to-understand label. (Perrone, 2/15)
Stat:
FDA Panel Recommends Approval Of Over-The-Counter Naloxone
Two manufacturers are applying for nonprescription status: Emergent BioSolutions — the focus of Wednesday’s meeting — and Harm Reduction Therapeutics, a nonprofit organization. The FDA granted both companies a priority review and is likely to issue an approval decision within months. (Facher, 2/15)
NBC News:
FDA Panel Recommends Making Opioid Overdose Antidote Available Over The Counter
“For the sake of the public and saving lives, I believe this medication should be available over the counter as soon as possible,” Dr. Katalin Roth, a professor of medicine at the George Washington University School of Medicine and Health Sciences, said following the vote. (Lovelace Jr., 2/15)
USA Today:
FDA's Advisory Committee: Make The Overdose-Reversal Drug Narcan Available For Retail Sale
All states have standing orders that allow a person to get naloxone from a pharmacist without a doctor’s prescription, but consumers must approach a pharmacist and ask for the medication before purchasing. Dr. Bobby Mukkamala, chair of the American Medical Association's substance use and pain care task force, said a retail version of the drug would make it easier for people to access. “Making naloxone over the counter is a safe and vital step to ending the nation’s overdose epidemic," Mukkamala said.
In related news about the opioid crisis —
North Carolina Health News:
Delayed Opioid Settlement Funds Strain Nonprofits
In October, a new clinic offering opioid addiction treatment opened in Guilford County. Patients get connected to the clinic by the post-overdose response team at an organization called Guilford County Solution to the Opioid Problem — better known as GC STOP. Now, 48 people who overdosed in the community have been connected to treatment and medication thanks to the new initiative, which was made possible by a grant using funds from a massive legal settlement with McKinsey & Company. (Knopf, 2/16)
The Colorado Sun:
Colorado Cities Could Allow “Overdose Prevention Centers” For Drug Users Under New Democratic Bill
Colorado cities could let “overdose prevention centers,” where people would be allowed to openly use illicit drugs under the supervision of health care workers or other trained staff, operate within their boundaries under a bill introduced in the state legislature Wednesday by four Democrats. (Paul, 2/15)
Philadelphia Inquirer:
New Jersey Lawmakers Want To Increase Penalties For Dealing And Possessing Fentanyl. Harm Reduction Advocates Say It Will Hurt People With Addiction
New Jersey lawmakers are advancing a pair of bills that would toughen sentences for fentanyl possession and dealing, which advocates for people who use drugs fear could end up deterring people from reporting overdoses and punish people struggling with addiction. (Whelan, 2/16)
AP:
Substances Fuel Record Homeless Deaths In Portland, Oregon
A record 193 homeless people died in Oregon’s Multnomah County, home to Portland, in 2021, a 53% increase compared with the previous year, according to a new county report released Wednesday. Substances contributed to about 60% of those deaths, the report found, mirroring trends seen across the country. (Rush, 2/15)