FDA (KFF Health News) ++++

FDA The New York Times: F.D.A. Opens Door To More Flavored E-Cigarettes https://www.nytimes.com/2026/03/09/health/fda-e-cigarettes-flavors.html?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-_no3VbqpKP5dAB9mvP4dRiidGKvapAohVhC_NKuL6J5y759kLK_8gErVFZbEmW1WJKuAEJQ_3P7ypSs2YtDGezErBpXg&_hsmi=407915789&utm_content=407915789&utm_source=hs_email The Food and Drug Administration said on Monday that it would open the door to e-cigarettes in flavors that it deems appealing to adults, shifting from the agency’s unsuccessful ban on fruit and candy-flavored versions that have continued to flood the market. The agency said in a document released on Monday that it would consider vapes in flavors such as mint, coffees, teas and spices, possibly like clove or cinnamon. The F.D.A. said it would continue to reject those offering sweet or fruity flavors that are more appealing to teenagers. (Jewett, 3/9) Bloomberg: FDA Plans To Loosen Testing Rules To Boost Biosimilar Drugs https://www.bloomberg.com/news/articles/2026-03-09/fda-plans-to-loosen-testing-rules-to-boost-biosimilar-drugs?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz--BJjCJRuTE6864jfATx1cz9jWvF_XX1eSLlsskeQdUkOyENhAyaK1Soe480hg39RoBVEXvKgI8GW02sGlCSSHAuj7UKw&_hsmi=407915789&utm_content=407915789&utm_source=hs_email&embedded-checkout=true The US Food and Drug Administration is easing some requirements for drugmakers developing copycat versions of costly biologic medications in a bid to bring more competition to the market and lower costs. The agency plans to reduce the need for some studies that demonstrate the drugs, called biosimilars, are equivalent to the brand-name medications they’re modeled on, according to an FDA official who asked not to be identified and a document reviewed by Bloomberg News. The agency estimates the change could shave $20 million from the cost of developing a new biosimilar drug. (Tozzi, 3/9) Undark: Why The FDA Is Embracing Old Math For New Drugs https://undark.org/2026/03/10/fda-bayesian-guidelines/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-9m3gdRXHaF5AUjlOXPgKNevDKq23KdFRKYz7KQnYHZc3pQDLmbN71Vp2D1eJ4cVrmGhUm8qWdQVqpT2BQMUsocCihoOQ&_hsmi=407915789&utm_content=407915789&utm_source=hs_email Clinical trials for a new drug can take years to complete, and cost up to hundreds of millions of dollars. New draft guidance from the U.S. Food and Drug Administration aims to make that process faster and cheaper for some studies, by encouraging a tool called Bayesian statistics. The approach dates back more than 250 years, and proponents say its embrace by regulators is overdue, stalled at first by feuding camps of statisticians, then later by a lack of familiarity among trained professionals. (Talpos, 3/10) Bloomberg: FDA Investigated Over Rare-Disease Drug Denials By Senator https://www.bloomberg.com/news/articles/2026-03-10/key-us-senator-investigates-fda-over-rare-disease-drug-denials?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz--D1gjigo1Bj1eq58QlgEz7DK1_CBB8TXnZbqDJIo6R-mcawRF-9VnbkT3aEZ_5ChaRaw3CN_SVY_Eest4cVMjE0VfbRQ&_hsmi=407915789&utm_content=407915789&utm_source=hs_email A key US Republican senator said he’s launched an investigation into the Food and Drug Administration’s recent denials of treatments for rare diseases, adding political pressure on an agency that’s already in turmoil. Wisconsin Sen. Ron Johnson said he’s seeking the FDA’s written denials to drugmakers, known as complete response letters. He plans to write letters to the agency asking why it denied certain drugs. He said he’s also considering having top FDA officials, including Commissioner Marty Makary, testify before the Senate’s Permanent Subcommittee on Investigations that he chairs. (Langreth, Smith, and Cohrs Zhang)

MORE ON THE TRUMP ADMINISTRATION (KFF Health News) ++

MORE ON THE TRUMP ADMINISTRATION NBC News: Mehmet Oz Says Obamacare Enrollment May Be ‘Too High’ https://www.nbcnews.com/health/health-news/dr-oz-trump-obamacare-aca-insurance-fraud-deductible-plans-rcna262468?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz--ha5mdq5539lIrPG0sjJQSMp_iYVtl04ytm3mfpNgDqpFx6YV8lcAM0yyhZiaWmQediGF2Icvo4wi4_Tpx3LTIXg1IZw&_hsmi=407915789&utm_content=407915789&utm_source=hs_email Although Obamacare sign-ups have fallen significantly this year over skyrocketing monthly premiums, Dr. Mehmet Oz believes enrollment is still too high. Oz, the Trump administration’s top official overseeing the Affordable Care Act, told NBC News that millions of people may be fraudulently enrolled or eligible for other types of coverage. About 23 million people signed up for ACA coverage during this year’s open enrollment period, which ended in January, according to the latest data from the Centers for Medicare and Medicaid Services. (Lovelace Jr., 3/9) CIDRAP: GAO Calls For Greater Transparency On High-Risk Pathogen Research https://www.cidrap.umn.edu/biosecurity-issues/gao-calls-greater-transparency-high-risk-pathogen-research?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-8EWE0PniwAUeUtjFGuNjYMv1OhaGEPDN6cTx9xKwJwsNh4zqun1y6V0ygpnD9frkBy0F04XkcN3cUlAbsf0aO0e2w5Wg&_hsmi=407915789&utm_content=407915789&utm_source=hs_email A new report from the US Government Accountability Office (GAO) says the Department of Health and Human Services (HHS) should make more information public about how it evaluates and mitigates risks associated with high-risk pathogen research. (Bergeson, 3/9)

'MAKE AMERICA HEALTHY AGAIN' (KFF Health News) ++

'MAKE AMERICA HEALTHY AGAIN' Politico: ‘I Share Your Outrage’: Democrats Woo MAHA Moms Ahead Of The Midterms https://www.politico.com/news/2026/03/09/i-share-your-outrage-democrats-make-overtures-to-maha-ahead-of-the-midterms-00817292?utm_campaign=KHN:+First+Edition&utm_medium=email&_hsenc=p2ANqtz-9mdNPrJ_RV0Kze3Gl39Ba9GGf1lDMf7kTac8dqq2HNrVPasLcdNBa1oQVERt0KbxvhIOcj46wXMPhKc7rPKp01PK4oZQ&_hsmi=407915789&utm_content=407915789&utm_source=hs_email The MAHA base is furious with the Trump administration over its promotion of a controversial pesticide. Democrats up for election this fall see a prime political opportunity in the infighting. President Donald Trump’s executive order on glyphosate, a chemical used in industrial farming, and Health Secretary Robert F. Kennedy Jr.’s defense of that move, drove a wedge into the Make America Healthy Again movement. As Trump’s Justice Department prepares to back the chemical maker’s Supreme Court bid for legal immunity, it’s exacerbating MAHA’s existing frustrations with an administration that has had a checkered record on addressing their top priorities. (Ollstein and Reader, 3/9) The 19th: MAHA Movement Gains Democratic Ally In Rep. Chellie Pingree https://19thnews.org/2026/03/chellie-pingree-farmer-congresswoman-maha/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-_rDWZqgR9GnxRfyj1xPpvionvBb9YFvQyWxIZGMQh2pBSAf5IDa9kpbO9WtRT7y4M9scMx30-U5a9o1Hw7WXjHy8lzdg&_hsmi=407915789&utm_content=407915789&utm_source=hs_email Long before entering politics, Rep. Chellie Pingree was a self-described hippie, a back-to-the-lander and an organic farmer. In the 1970s, after attending college in Maine, she saw an opportunity to live a more sustainable life there. She decided to stay, and moved to an island off the coast where she and her husband started a small farm and sold their produce at a local market. (Kutz, 3/9)

Military.com: 'Saving Lives': Bill Would Fund Psychedelic Therapies For Military Veterans (KFF Health News)

https://www.military.com/daily-news/2026/03/09/saving-lives-bill-would-fund-psychedelic-therapies-military-veterans.html?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-8GNjYybiC9PArUYtDlNoVP_A7bhZvkrp_mdtTdSCZqD4imdWZ9cJWFyvYewVC8Mp4Xa8qD7yEvDbNbluxN8SzQfk8_mQ&_hsmi=407915789&utm_content=407915789&utm_source=hs_email Military.com: 'Saving Lives': Bill Would Fund Psychedelic Therapies For Military Veterans New legislation introduced in Congress would require the Veterans Affairs (VA) secretary to designate the department’s medical facilities as “innovative therapies centers of excellence,” which would include increasing federal funding to study the therapeutic uses of psychedelics for veterans, according to a copy of the legislation shared with Military.com. The “Innovative Therapies Centers of Excellence Act of 2025” sponsored by U.S. Sen. Ruben Gallego (D-AZ), a U.S. Marine Corps veteran, would designate not fewer than five VA medical facilities that can offer these different therapeutic modalities. (Mordowanec, 3/9)

HEALTH CARE INDUSTRY & PHARMACEUTICALS +++ +++++ (KFF Health News)

HEALTH CARE INDUSTRY Fierce Healthcare: Leapfrog Ordered To Remove Safety Grade For 5 Tenet Hospitals https://www.fiercehealthcare.com/providers/leapfrog-ordered-remove-safety-grade-5-tenet-hospitals?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz--xfuEfhFmx-eSnNKnTDDv92-z1BgnQkNdQMX_ny529IpFO-7UcymmCHhMe960B-2BVTyKsGakgUdtPPmfr8ws-FbrhWg&_hsmi=407915789&utm_content=407915789&utm_source=hs_email A federal judge has ruled against the Leapfrog Group in a suit brought by Tenet Healthcare subsidiary hospitals that said they were punished for not voluntarily submitting data to the hospital safety grading nonprofit. The ruling, handed down Friday, focuses on a methodology change Leapfrog implemented ahead of the fall 2024 publication of its hospital safety grades. The approach more heavily weighed “imputed” scores for four of Leapfrog’s 32 safety measures that were assigned when recent safety data for the two preceding years are unavailable. (Muoio, 3/9) Fortune: Healthcare Jobs—Which Have Been Propping Up Labor Market—Just Shrank For First Time In Four Years https://fortune.com/2026/03/09/healthcare-jobs-plummet-first-time-four-years-labor-market-economy-jobs-report/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-_quZ5ytDkn8fCrSb6VA1ypSu30mZFCyXHerCJfGa_oQnct3zqudxHK857pZET_GkGGOMuLRRCYU0kGboZ_s_2ikbMq4A&_hsmi=407915789&utm_content=407915789&utm_source=hs_email Despite making up nearly a fifth of the U.S. economy and providing a much-needed set of crutches, the latest health care jobs data highlights just how wobbly the labor market is. Over 28,000 jobs in the health care industry were lost in February, according to the Bureau of Labor Statistics jobs report on Friday, making up nearly one-third of the 92,000 total jobs lost for the month. The dip marks the sector’s first decline in more than four years. (Rogelberg, 3/9) Stat: Talkspace To Be Acquired By Mental Health Services Giant https://www.statnews.com/2026/03/09/talkspace-to-be-acquired-for-835-million-by-mental-health-services-giant/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-9JiNqyNS-GINzU6iL7GNikF65aRLm-RSHk4_0nNuRRXqSFTPrzkQVmqn0W9EwTzrgYAQF1_7XNdCbZL1rufHgd3yWWPw&_hsmi=407915789&utm_content=407915789&utm_source=hs_email Universal Health Services, a behavioral health provider that operates over 340 inpatient facilities across 40 states, announced Monday that it will acquire virtual mental health company Talkspace for $835 million, marking a new chapter for a digital health leader that has often been considered ripe to be picked up by a larger organization. (Aguilar, 3/9) PHARMACEUTICALS MedPage Today: Cancer Drug Pulled From Market Over Safety Concerns https://www.medpagetoday.com/hematologyoncology/lymphoma/120234?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-8OS1kH0fXXZ0BaXJ1vw08gnysmhokN5Y99bCb_dHYQ2m_QLK1kjEwayXpvb9MfYhebCvwQ9e2aiY9_MCFiDoHie0fa3g&_hsmi=407915789&utm_content=407915789&utm_source=hs_email The cancer drug tazemetostat (Tazverik) is being voluntarily withdrawn in the U.S. and all other markets over concerns about secondary cancers, drugmaker Ipsen announced. The company also said it is discontinuing all active trials of the EZH2 inhibitor and any expanded access programs. (Bassett, 3/9) MedPage Today: Another Study Finds No Ties Between Tylenol In Pregnancy And Autism https://www.medpagetoday.com/pediatrics/generalpediatrics/120232?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-_CNM62uTDCuO8bT66HYUO94qB9aWFzuAtCx6DwIR_26ik6POYSpk6B-Ydnso2FJJr8Es-2UM2U6vQc0RCCS7VfCmnYrA&_hsmi=407915789&utm_content=407915789&utm_source=hs_email Positive associations between maternal acetaminophen prescriptions during pregnancy and attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) in offspring became null in sibling-matched analyses, a nationwide cohort study in Taiwan found. (Henderson, 3/9) CIDRAP: Study Links Fluoroquinolone Antibiotics To Increased Risk Of Panic Attacks https://www.cidrap.umn.edu/antimicrobial-stewardship/study-links-fluoroquinolone-antibiotics-increased-risk-panic-attacks?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-8u0-w2Agwy9dgyQ8EqeytbR-E93b7K00ulmIs8k5ozqywf9Mgdvv0tlrrpcv8oaGp-QWlIsGcWxId97SfoU275U8c0Dw&_hsmi=407915789&utm_content=407915789&utm_source=hs_email A new study by a team of Canadian researchers hints at a potential link between fluoroquinolone antibiotics and increased risk of panic attacks. Although fluoroquinolones are among the most widely prescribed antibiotics, they've been linked to an array of side effects, including tendinitis and tendon rupture, peripheral neuropathy (a nerve condition that causes weakness, numbness, and pain in the hands and feet), and central nervous system effects. (Dall, 3/9) CBS News: Penn Medical Student With Rare Genetic Form Of ALS On Mission To Develop Gene Therapy https://www.cbsnews.com/philadelphia/news/als-research-penn-medical-student/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-_AqGM1jQ6n1-Dtx4wMPN3ZtD3wMXv-cdMpNYkNIpNvKpUV8X7cy2Od6Sw4sAeONFzQw1pryMeVEknwz28zxfJUgkbdJg&_hsmi=407915789&utm_content=407915789&utm_source=hs_email A medical student at the University of Pennsylvania is on a special mission in the research lab that could save her life. Yentli Soto Albrecht's battle is against ALS, a fatal neurodegenerative disease. She has a rare genetic form of the disease. It's a race against time in the research lab for Soto Albrecht, who is an MD/PHD student at the Perelman School of Medicine. (Stahl, 3/9) Becker's Hospital Review: Digital Nudges Help GLP-1 Users: Stanford https://www.beckershospitalreview.com/healthcare-information-technology/digital-health/digital-nudges-help-glp-1-users-stanford/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-9J0g9KmxlPVqBcgvfaHjlxYX7u1jT2PrF4j1yLtiAjucNDbM9XQjsK-0enYPIZeC8_a9xgzZGAXjICWj56J9NFN7zyQg&_hsmi=407915789&utm_content=407915789&utm_source=hs_email Digital lifestyle nudges can help GLP-1 users focus on healthier habits, according to a study at Stanford (Calif.) Medicine. The researchers conducted an online randomized trial of over 5,000 adults using the weight-loss medications across the globe, finding that low-cost digital interventions increased their expectation that they would adopt healthy behaviors, with effects lasting up to two weeks, per the March 9 study in JAMA Network Open. (Bruce, 3/9)

Medicaid Waiver Tracker: Approved and Pending Section 1115 Waivers by State Published: Mar 9, 2026

https://www.kff.org/medicaid/medicaid-waiver-tracker-approved-and-pending-section-1115-waivers-by-state/

What Medicare’s Temporary Program Covering GLP-1s for Obesity Means for Beneficiaries Published: March 9, 2026

https://www.kff.org/quick-take/what-medicares-temporary-program-covering-glp-1s-for-obesity-means-for-beneficiaries/