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The Health 202

A newsletter briefing on the health-care policy debate in Washington.

Will an overdose reversal drug be available over-the-counter?

The Health 202

A newsletter briefing on the health-care policy debate in Washington.

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Today’s edition: The Biden administration unveils its next attempt at cracking down on drug prices. The details on Nikki Haley’s abortion record as she jumps into the 2024 presidential race. But first … 

FDA’s advisers weigh whether Narcan should be available over-the-counter

On tap today: The Food and Drug Administration’s expert advisers will consider whether the agency should make a key opioid overdose reversal drug available over-the-counter, a move advocates say will boost access to the treatment.

Late last year, the FDA signaled it would start greenlighting naloxone products for over-the-counter use. Emergent BioSolutions quickly took the agency up on its offer, and the FDA fast-tracked the company’s request in December. 

The Biden administration has made increasing the availability of the drug — which can reverse an overdose within several minutes — a key plank of its strategy to combat the opioid epidemic. For years, federal and state health officials have sought to do the same, but barriers to obtaining the medication still exist. 

“I believe that it should be as available and everywhere as condoms are today,” said Ryan Hampton, a national addiction recovery advocate. “Every truck stop and vending machines and pharmacies and grocery stores should be carrying it.”

The details

An injectable form of the drug naloxone has been around since the 1970s. And in 2015, the agency approved the first naloxone nasal spray, often called Narcan.

Nearly a decade later, an FDA advisory panel will vote this afternoon on whether Emergent’s nasal spray is safe and effective for nonprescription use. The advisers are also being asked to discuss whether a study showed that consumers can correctly administer the drug in an emergency situation, if improvements are needed to the pictogram showing how to use Narcan and more. 

In general, the drug has been deemed as safe, and experts say there isn’t potential for it to be misused since it blocks the effects of opioids.

The timeline: The FDA is expected to make its decision by March 29. The agency isn’t required to follow the advisory panel’s recommendations, but it typically does. However, the product, if approved, may not hit the shelves until late summer. That’s because production of Narcan for the over-the-counter market won’t begin until after the agency signs off on the plan, an Emergent spokesperson wrote in an email. 

The missing piece: How much will it cost? The company didn’t provide details on the expected price. Some people may be unable to afford the drug if insurance doesn’t cover the over-the-counter product. The drug manufacturer says it’s had conversations with lawmakers, federal officials and private industry on this question, and insurance coverage is “not an issue Emergent can solve and may require government action in many cases.”


Both Democrats and Republicans have pledged to combat the country’s drug crisis as nearly 300 people in the United States die of overdoses per day. Former president Donald Trump declared a public health emergency to combat the opioid epidemic, which the Biden administration has continued to renew. 

In recent years, every state has put in place laws or mechanisms aimed at easing access to naloxone. 

Some of that has been done through what’s known as a standing order. This essentially allows licensed pharmacists to dispense naloxone to anyone who meets the criteria designated by the state. That usually includes those at risk of overdoses, their families and friends, and more.

But federal officials and advocates say so-called standing orders haven’t eliminated the hurdles of obtaining the opioid overdose reversal drug. The stigma of asking for the medication may prevent some from asking a pharmacist for the medication. And some pharmacies fail to carry the product on hand, which may be due to “pharmacists’ lack of familiarity or understanding of standing orders without a patient-specific prescription,” the FDA wrote in briefing documents released ahead of the meeting. 

  • “It’s certainly easier to pick it up off of a shelf than to sometimes wait in line and talk to a pharmacist. So there may be some real advantages to the potentially easy access in a pharmacy aisle instead of behind the counter,” Wilson Compton, the deputy director of National Institute on Drug Abuse, told The Health 202.

Agency alert

HHS unveils three new drug pricing pilot programs

The Biden administration is planning to launch three new pilot programs aimed at lowering prescription drug prices for those with Medicare and Medicaid coverage.

The Center for Medicare and Medicaid Innovation will test the models, which are designed to complement the prescription drug provisions included in Democrats’ sweeping economic package signed into law last year. The programs are:

  • The Medicare $2 drug list: Under this model, the agency plans to encourage sponsors of Medicare’s voluntary prescription drug benefit to offer generic drugs for common, chronic conditions like hypertension for a flat $2 monthly co-pay, in an effort to standardize cost-sharing across plans. The model will likely be voluntary for participants.
  • The Cell and Gene Therapy Access Model: This program permits state Medicaid agencies to delegate authority to CMS to coordinate and administer multistate agreements with manufacturers for payment based on patients’ health outcomes. It is expected to be voluntary.
  • The Accelerating Clinical Evidence Model: This proposal creates new payment methods for drugs put on the market via the Food and Drug Administration’s accelerated approval process, with the goal of encouraging drug companies to complete confirmatory trials in a timely fashion. The pilot program is more likely to be mandatory than the other two, senior CMS officials said.

The road map outlined by the administration yesterday is only the beginning; it will likely be years before the programs are put into motion. For instance: Development on the Medicaid gene and cell therapy model will start this year and could launch as early as 2026. The agency is still hammering out a timeline for the other programs. 

The pilot programs were released in response to an executive order President Biden signed in October calling on the federal health department to explore new health-care payment and delivery models that would lower drug costs. They also come as Biden seeks to harness his administrative powers to enact drug pricing reforms amid a divided Congress that will stymie his legislative agenda. 

CMS Administrator Chiquita Brooks-LaSure: 

2024 election watch

Haley launches 2024 presidential bid

Nikki Haley, who served as U.N. ambassador and governor of South Carolina, is throwing her hat into the ring in the 2024 presidential race. She is the first major rival to officially challenge Donald Trump for the Republican nomination. 

Haley’s announcement yesterday drew starkly different reactions from both sides of the abortion debate. Antiabortion groups like Susan B. Anthony Pro-Life America celebrated her bid for election, calling Haley a “strong pro-life, pro-woman” leader. Abortion rights groups denounced her campaign, with NARAL Pro-Choice America contending Haley’s track record on the issue is “chock full of red flags.” 

Here’s a snapshot of Haley’s record on abortion: While governor, she signed a law in 2016 banning the procedure in South Carolina after 19 weeks of pregnancy, unless the mother’s life is at risk or if a doctor determines the fetus cannot survive outside of the womb. 

In June, she celebrated the Supreme Court’s ruling overturning the constitutional right to abortion, calling the decision “a historic win for the pro-life movement.” Last month, Haley urged Congress to support a Republican-backed bill aimed at compelling doctors to provide care to infants who survive an attempted abortion, a situation that is rare, the Washington Examiner reported. The legislation passed in the House, but is unlikely to get a vote in the Democratic-controlled Senate. 

From our notebook

More on the Medicare Advantage wars

Here’s one thing to keep an eye on: A study from Avalere estimates that the administration’s proposed 2024 payment rates for private Medicare plans could result in a $540 decrease in benefits annually per member, estimating that could have an impact on premiums and supplemental benefit offerings.

The study, shared with The Health 202, was funded by Better Medicare Alliance, which advocates for Medicare Advantage plans. The analysis by Avalere, which says it retained editorial control over its calculations, departs in some ways from the methodology used by the Centers for Medicare and Medicaid Services, with Avalere saying the agency made assumptions that might not play out in the future.

BMA has made the argument to Capitol Hill that the proposal from the Centers for Medicare and Medicaid Services would result in cuts to plans, which the administration fiercely disputes, and says CMS should reverse its proposal. Some Republicans have also leveled similar charges as the partisan feud over the major federal health insurance program heats up.

The other side: Top federal health officials say their calculations show their plan would lead to a roughly 1 percent increase in payments. Asked to comment on the new analysis, the Department of Health and Human Services said that "cherry picking certain policies” doesn’t give the full picture. In a statement, HHS spokesperson Kamara Jones said “recouping overpayments from insurance companies is not a cut – it’s our job. … Leave it to an insurance industry front group to call an increase in Medicare Advantage payments a cut.”

In other health news

  • Women Speak Out PAC endorsed former Justice Daniel Kelly in the Wisconsin Supreme Court race yesterday. The PAC, a partner of prominent antiabortion group Susan B. Anthony Pro-Life America, pledged a six-figure investment ahead of the Feb. 21 primary election, which could determine the future of abortion access in the state. 
  • Medicare advisers recommended yesterday that the program change its requirements for medications, diagnostics and medical devices that face coverage restrictions, including clarifying a policy that orders drugmakers to conduct follow-up research on their product to prove it works well enough to receive full Medicare coverage, Stat’s Rachel Cohrs reports. 
  • The number of Americans with medical debt on their credit reports dropped by nearly 18 percent between 2020 and 2022, according to a report released yesterday by the Consumer Financial Protection Bureau.

Health reads

Quick-acting male birth control drug shows promise in the lab (By Carolyn Y. Johnson | The Washington Post)

Post-Roe, Native Americans face even more abortion hurdles (By Laura Ungar and Heather Hollingsworth | The Associated Press)

According to Medical Guidelines, Your Doctor Needs a 27-Hour Workday (By Gina Kolata | The New York Times)

Sugar rush

Thanks for reading! See y'all tomorrow.