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FDA’s new voucher program hints at broader policy agenda, making many ‘uncomfortable’

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While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Review voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.

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Tennessee pharmacies sell potent ivermectin, led by anti-vaccine doctor who’s taken ‘bucketloads’

The drug is now marketed and sold across the state in roadside shops and small-town strip malls with little oversight from health authorities. Highway billboards advertise ivermectin as “Available Without a Prescription in Tennessee!” while dozens of pharmacies offer highly concentrated pills, sometimes at 10 or 20 times the potency of a standard tablet.

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The drug is now marketed and sold across the state in roadside shops and small-town strip malls with little oversight from health authorities. Highway billboards advertise ivermectin as “Available Without a Prescription in Tennessee!” while dozens of pharmacies offer highly concentrated pills, sometimes at 10 or 20 times the potency of a standard tablet.

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STAT+: CMS recalculates Medicare Advantage star ratings again, adding more volatility to program

Federal officials have recalculated the quality ratings for 2026 Medicare Advantage plans, a new government memo shows. The consequential decision was prompted by yet another legal action from the health insurance industry.

Over the past few years, health insurance companies that sell Medicare Advantage plans have inundated the Centers for Medicare and Medicaid Services with lawsuits that challenged their lower star ratings, which jeopardized taxpayer-funded bonuses. Many insurers have lost their cases, but a handful have won. Two years ago, CMS had to redo Medicare Advantage star ratings after federal judges said the government erred with its original calculations.

Medicare Advantage plans that get at least four out of five stars get bonus payments. Those bonuses have ballooned to $16 billion this year — almost the entire budget of the Centers for Disease Control and Prevention and an amount that has doubled since 2020

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Federal officials have recalculated the quality ratings for 2026 Medicare Advantage plans, a new government memo shows. The consequential decision was prompted by yet another legal action from the health insurance industry.

Over the past few years, health insurance companies that sell Medicare Advantage plans have inundated the Centers for Medicare and Medicaid Services with lawsuits that challenged their lower star ratings, which jeopardized taxpayer-funded bonuses. Many insurers have lost their cases, but a handful have won. Two years ago, CMS had to redo Medicare Advantage star ratings after federal judges said the government erred with its original calculations.

Medicare Advantage plans that get at least four out of five stars get bonus payments. Those bonuses have ballooned to $16 billion this year — almost the entire budget of the Centers for Disease Control and Prevention and an amount that has doubled since 2020

Continue to STAT+ to read the full story…

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STAT+: FDA advisory panel endorses Moderna mRNA flu vaccine that was subject of controversy

A panel of advisers to the Food and Drug Administration gave its endorsement Thursday to a seasonal mRNA flu vaccine that was developed by Moderna and that earlier this year became the subject of controversy when a top agency official briefly refused to even consider accepting it for review.

The Vaccines and Related Biological Products Advisory Committee — known as VRBPAC — voted unanimously that the benefits of the vaccine outweigh the risks for both adults aged 50 to 64, and those 65 and older. It remains to be seen what the FDA will decide, but staff presentations during the meeting suggested the agency sees the vaccine as having cleared sufficient hurdles to be licensed via a traditional pathway for the younger group, and an accelerated pathway for the older group. 

Multiple flu vaccines currently on the market were first licensed using an accelerated pathway, Wellington Sun, a former FDA employee, noted during the meeting’s public comment period. (After leaving FDA, Sun worked for Moderna, but he is no longer with the company.)

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A panel of advisers to the Food and Drug Administration gave its endorsement Thursday to a seasonal mRNA flu vaccine that was developed by Moderna and that earlier this year became the subject of controversy when a top agency official briefly refused to even consider accepting it for review.

The Vaccines and Related Biological Products Advisory Committee — known as VRBPAC — voted unanimously that the benefits of the vaccine outweigh the risks for both adults aged 50 to 64, and those 65 and older. It remains to be seen what the FDA will decide, but staff presentations during the meeting suggested the agency sees the vaccine as having cleared sufficient hurdles to be licensed via a traditional pathway for the younger group, and an accelerated pathway for the older group. 

Multiple flu vaccines currently on the market were first licensed using an accelerated pathway, Wellington Sun, a former FDA employee, noted during the meeting’s public comment period. (After leaving FDA, Sun worked for Moderna, but he is no longer with the company.)

Continue to STAT+ to read the full story…

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