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Stakeholders blast FDA panel's rejection of MDMA therapy |
An advisory committee for the Food and Drug Administration (FDA) voted against recommending MDMA-assisted therapy for PTSD, drawing backlash from lawmakers and advocates. |
The members of the FDA's Psychopharmacologic Drugs Advisory Committee voted 9-2 against endorsing the efficacy of MDMA as a treatment for PTSD and 10-1 to reject the question of whether the benefits outweigh the risks. The FDA, which designated MDMA-assisted therapy as a "breakthrough therapy" in 2017, is considering an application by Lykos Therapeutics to approve the proposed treatment for PTSD. This was the first time the U.S. had considered a Schedule I drug for medical use. A Schedule I designation means a substance has no accepted medical use and a high potential for abuse. "I'm disappointed that the FDA advisory committee chose to ignore the voices and testimonies of Veterans whose lives have been forever improved by MDMA-assisted therapy, and instead voted in favor of those who have been on a mission to discredit this promising treatment at all costs," Rep. Jack Bergman (R-Mich.), a retired lieutenant general in the U.S. Marine Corps, told The Hill. "This is a first cure that promises to revolutionize psychiatric treatment in like 50, 60 years, and they're denying it? Are you kidding me?" Rep. Lou Correa (D-Calif.), who co-chairs the Congressional Psychedelics Advancing Therapies Caucus with Bergman, said in an interview with The Hill. While panelists said they were excited by the results, they felt the treatment was still too experimental. "While we are disappointed in the vote, we are committed to continuing to collaborate with the FDA with their ongoing review," Lykos CEO Amy Emerson said in a statement. "There is an urgent need for new, effective and accessible therapies to address this unmet need for those living with PTSD." Read more here from The Hill's Taylor Giorno |
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 Food and Drug Administration (FDA) announced it was rescinding its order to ban the sale of Juul electronic cigarettes, or e-cigarettes, in light of new case law. About two years ago, the FDA banned Juul from selling and marketing its e-cigarette products, saying at the time the company had failed to prove keeping its products on the market "would be appropriate for the protection of the public health." Juul products have … |
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A Food and Drug Administration (FDA) panel's surprising recommendation this week to reject the use of MDMA, commonly known as ecstasy, to treat PTSD was a blow to advocates and lawmakers who champion the treatment as a game changer for mental health in the United States. The FDA, which designated MDMA-assisted therapy as a "breakthrough therapy" in 2017, is considering an application by Lykos Therapeutics to approve the proposed … |
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Branch out with a different read: |
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Report shows a drop in drug overdose deaths in Kentucky but governor says the fight is far from over |
FRANKFORT, Ky. (AP) — Drug overdose deaths in Kentucky fell nearly 10% in 2023, marking a second straight annual decline in the fight against an addiction epidemic that’s far from over, Gov. Andy Beshear said Thursday. The number of fatal overdoses statewide dropped below 2,000, as officials credited a comprehensive response that … | |
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Local and state headlines on health care: |
- State rejects health insurers' pleas to halt plan that will shake up coverage for 1.8 million Texans (The Texas Tribune)
- In funding crisis, Denver Health Medical Center wants voters to approve a sales tax (CBS News)
- Advocacy group calls on Maryland candidates to protect health subsidies (WYPR)
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Health news we've flagged from other outlets: |
- Medicaid expands mental health clinic funding (Axios)
- Whooping cough cases double in the U.S., a potential legacy of the pandemic (The Washington Post)
- First U.S. case of sexually transmitted fungal infection found in New York City (Time)
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