 Health Care |
Health Care |
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FDA approves nonprofit's opioid overdose reversal drug
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The Food and Drug Administration on Friday approved the first version of over-the-counter naloxone from a nonprofit company, a move that could bring cheap and even free doses of the opioid overdose drug to Americans who need it most.
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RiVive, made by Harm Reduction Therapeutics, is the second over-the-counter naloxone product approved by the FDA this year.
Naloxone is a medicine that can help reduce opioid overdose deaths and when administered timely — usually within minutes of the first signs of an opioid overdose — can counter the overdose effects. The company said it anticipates RiVive will be available in early 2024, primarily to harm-reduction organizations and state governments at a lower price than other opioid reversal nasal sprays.
The nonprofit said it is focused on supplying RiVive to communities that need it most and will make at least 200,000 doses — 10 percent of projected initial annual product production — available for free.
"We are grateful that FDA granted RiVive approval so we can now achieve what most thought impossible and no other company has: broad delivery of a lower-cost nasal naloxone product without a prescription to save lives that could otherwise be lost to opioid overdose," Michael Hufford, co-founder and chief executive officer of Harm Reduction Therapeutics, said in a statement.
Unlike other naloxone products, Harm Reduction Therapeutics said it will make RiVive available for free or at low break-even cost, which the company previously said was about $18.
Narcan is the most common naloxone product, and the FDA approved an over-the-counter version in March.
But price can be a significant barrier because a two-pack of the prescription version can cost $130 to $150, depending on the retailer. Even the discount price of around $50 can still be a barrier.
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Welcome to The Hill's Health Care newsletter, we're Nathaniel Weixel and Joseph Choi — every week we follow the latest moves on how Washington impacts your health. |
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How policy will be impacting the health care sector this week and beyond: |
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The first 10 drugs selected for Medicare price negotiation will be announced by Sep. 1 and will set the stage for unprecedented government action regulating drug costs, with billions of dollars at stake and scores of patients standing to benefit. Once the initial batch of drugs chosen for negotiations are announced, the years-long negotiation process — currently being challenged in courts — will kick off. The manufacturers … |
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| The Department of Labor is cracking down on child labor violations even as multiple states have taken steps to loosen regulations around teenagers in the workplace. |
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A group of Democratic senators on Friday urged the manufacturer of the first over-the-counter birth control pill available in the U.S. to set an affordable retail price and begin "broad distribution" as soon as possible. Opill, which is made by the Dublin-based Perrigo, was approved for sale without a prescription by the Food and Drug Administration earlier this month, becoming the first of its kind in the U.S. |
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Upcoming news themes and events we're watching: |
- Congress is going into a month-long recess with several loose ends that will need to be tied up before the Sep. 30 deadline to avert a government shutdown, including bills to fund the FDA and the Department of Health and Human Services.
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Branch out with a different read from The Hill: |
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Sprains, strains and ACL tears. What to know about some of the NFL's most common injuries |
Hamstring pulls, ligament tears and ankle sprains can be as formidable an opponent for NFL teams as a high-scoring offense or stingy defense. "There's a 100% injury rate in the NFL," seven-time Super Bowl champion Tom Brady once said. Navigating those injuries could make the difference between a squad seeing its season sink or beating … |
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Local and state headlines on health care: |
- After Mississippi banned his hormone shots, an 8-hour journey (The Washington Post)
- "Scared out of my mind": A family scrambles after their disabled 3-year-old loses Medicaid (Texas Tribune)
- In Wisconsin, women's health care is constricted by an 1849 law. These doctors are aghast (KFF Health News)
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Health news we've flagged from other outlets: |
- Fatigue can shatter a person (The Atlantic)
- Nearly 4 million in U.S. cut from Medicaid, most for paperwork reasons (Washington Post)
- House GOP offers new plan to stem drug shortages, including cancer drug shortages (Stat)
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Most read stories on The Hill right now: |
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Justice Samuel Alito said Congress has "no authority" to regulate the Supreme Court in an interview with the Wall Street Journal’s opinion section … Read more |
| Rep. Robert Garcia (D-Calif.) mocked Rep. Marjorie Taylor Greene's (R-Ga.) call for decorum at a House subcommittee hearing Thursday, pointing to the … Read more |
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You're all caught up. See you next week! |
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