Axios

Food and Drug Administration advisers on Wednesday unanimously endorsed making a nasal spray antidote for opioid overdoses available for over-the-counter use, setting up an agency decision on whether to make it available for national distribution.

Why it matters: This is the closest any opioid reversal drug in the U.S. has gotten to not requiring a provider’s signoff, which public health experts and advocates have said will be critical in ending the overdose crisis that has killed more than 100,000 Americans in the past year.

Catch up quick: The FDA fast-tracked the application for a nonprescription version of Emergent BioSolutions' Narcan in December after pushing drugmakers to submit applications for one last fall.

• Most states already have a standing order that allows people to bypass the prescription requirement.
• But Jody Green, deputy director of safety in the FDA's division of nonprescription drugs, said that some pharmacists find the orders complicated and not all stock the drug, known as naloxone.
• Stigma around drug use can also inhibit people from purchasing the nasal spray if it means interacting with a pharmacist.

Zoom in: Discussion among panel members mostly focused on whether the instruction labels were clear enough for anyone to use the product without risk, and pointed to the greater issue of limited public health messaging regarding naloxone.

Yes, but: “Much of that is beyond what you can put on a drug label,” said Theresa Michele, the director of FDA’s nonprescription drugs office.

• The FDA also doesn’t have the authority to require post-marketing safety monitoring for nonprescription drugs, Michele added.
• Bonnie Milas, a cardiac anesthesiologist at the University of Pennsylvania, recalled how her husband , who has no medical training, was able to rescue their sons with naloxone. Her sons later died from unrelated accidental fentanyl overdoses.
• “After having lost my sons, you might say ‘Why would I argue to have naloxone over the counter?’” Milas said. “It’s because naloxone gave them a chance at recovery ... it was a chance to live a full life.”

Conditions to be met for nonprescription drugs include adequate labeling that allows consumers to self-treat without a health care provider present, low potential for misuse and a benefit that outweighs risk.

What they’re saying: Labeling delays shouldn't stymie the approval process, said Stephen Clement, a voting committee member and University of Virginia professor of medical education, “because this drug needs to get out to patients.”

What’s next: The FDA is expected to make a decision by the end of March, and it's unlikely the agency will hold up Narcan's application due to labeling questions, Brian Malkin, an attorney who specializes in FDA drug regulation, told Axios.

• The Biden administration has also identified wider access to naloxone a priority in its strategy to combat the opioid crisis.
• The cost of the drug hasn’t been publicly disclosed, but Emergent BioSolutions plans to "maintain affordability," said company spokesperson Matt Hartwig.
• Some outside estimates range from $32 to $176 — a price tag that could prohibit those most in-need from obtaining it.

The Biden administration unveiled three drug payment programs Tuesday aimed at helping reduce patients' out-of-pocket costs, including one that would potentially lower Medicare payments for promising treatments approved by the FDA before clinical trials are complete.

Why it matters: The models wade into some of the most timely drug pricing issues of the day, and could boost President Biden's political arsenal for 2024.

Top doctors groups are pressing Congress to overhaul the way Medicare pays physicians just as lawmakers are getting pulled into the politically charged debate over possible cuts to entitlement programs.

Why it matters: The new appeals serve notice that there's political risk if provider cuts become part of conservative-led efforts to balance the federal budget or a deal on raising the debt limit.

South Dakota has become the second state to ban gender-affirming care for transgender youth after Republican Gov. Kristi Noem signed the controversial bill into law.

The big picture: South Dakota is one of several GOP-led states escalating attacks on trans rights through legislation that often targets youth. More than two dozen bills targeting trans health care were introduced at the start of 2023 state legislative sessions.

A new Centers for Medicare and Medicaid Services rule would require nursing homes to disclose more details about their ownership, including whether private equity or real estate investment trusts have a stake in the facilities or companies providing services onsite.

Why it matters: Biden administration health officials on Monday cited research showing residents in nursing homes acquired by private equity were 11.1% more likely to have a preventable emergency department visit and 8.7% more likely to experience a preventable hospitalization.

While Republicans have largely said that abortion is a state issue following the fall of Roe v. Wade, conservative-led states are now on record backing a nationwide injunction on the use of a key drug used in medication abortions.

Driving the news: 22 Republican state attorneys general filed a brief Monday in a case brought by an anti-abortion group, asking a U.S. District Court in Amarillo, Texas, to block the Food and Drug Administration's 2000 approval of mifepristone — a move that abortion advocates say would effectively result in a national ban.

The teen mental health crisis is worsening by almost any measure. But it's affecting girls almost twice as much as boys, according to new federal data.

The big picture: A pronounced gender gap in who is experiencing suicidal thoughts, sexual assault and persistent feelings of sadness or hopelessness point to the need for more tailored interventions and support.

Congress is venturing into unknown and potentially explosive territory with the first House GOP-led investigation into COVID-19 vaccines.

Why it matters: It’s expected to be a showdown across the spectrum of views on vaccine safety and efficacy, from attempting to undermine public faith in them to trying to bolster confidence.

Equatorial Guinea has confirmed its first-ever outbreak of the Marburg virus disease, the World Health Organization said on Monday.

Driving the news: At least nine recent deaths in the country have been linked to the Marburg virus, which is highly infectious and has a fatality rate of up to 88%, the WHO said.