Category: Policy
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STAT+: Vinay Prasad tapped to run FDA center that regulates vaccines, gene therapies
STAT+: Vinay Prasad tapped to run FDA center that regulates vaccines, gene therapies WASHINGTON — Vinay Prasad, an academic and fierce critic of the medical mainstream, will be the next director of the Food and Drug Administration center that oversees the regulation of vaccines, gene therapies, and the blood supply. Prasad, previously an epidemiology professor at…
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STAT+: Few drugmakers embrace a newer test for contamination, placing horseshoe crabs at risk
STAT+: Few drugmakers embrace a newer test for contamination, placing horseshoe crabs at risk Many large drugmakers are still using a decades-old test — derived from horseshoe crabs — as a go-to tool for detecting contamination in medicines and vaccines, rather than switching to a cheaper and equally effective alternative, according to a survey by…
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STAT+: Vinay Prasad, in his own words, outlines the philosophy he’ll bring to the FDA
STAT+: Vinay Prasad, in his own words, outlines the philosophy he’ll bring to the FDA People seeking roles in government are often careful about what they say in public, or at least somewhat hesitant to freely share their opinions. It’s difficult to know exactly what’s going on in their heads. Not Vinay Prasad. The new…
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STAT+: GOP hits resistance on Medicaid cuts, and a brewing plan to lower drug prices
STAT+: GOP hits resistance on Medicaid cuts, and a brewing plan to lower drug prices You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. A horse named Journalism was favored to win the…
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STAT+: Trump signs order in bid to boost pharma manufacturing in the U.S.
STAT+: Trump signs order in bid to boost pharma manufacturing in the U.S. Amid ongoing anticipation over tariffs on pharmaceuticals, President Trump on Monday signed an executive order designed to lower regulatory hurdles and make it faster for drug companies to manufacture their products in the U.S. The move also includes plans to place more…
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Opinion: STAT+: Bristol Myers Squibb CEO: Pharmaceutical innovation requires bold yet predictable U.S. policy
Opinion: STAT+: Bristol Myers Squibb CEO: Pharmaceutical innovation requires bold yet predictable U.S. policy Having grown up in rural Arkansas, I have an acute awareness of the challenges many in our country face when it comes to health care. Quality care wasn’t always accessible, and the decision of whether to pay medical or utility bills…
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STAT+: Trump proposes billions in cuts to federal health agencies from NIH to CDC
STAT+: Trump proposes billions in cuts to federal health agencies from NIH to CDC WASHINGTON — President Trump on Friday proposed massive cuts to the federal government’s health agencies in his 2026 budget request, arguing that Congress should reduce spending by tens of billions from current levels. The request would be a 26% cut to…
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STAT+: MilliporeSigma will add temporary tariff surcharges on products shipped to the U.S.
STAT+: MilliporeSigma will add temporary tariff surcharges on products shipped to the U.S. MilliporeSigma, one of the largest suppliers of medical research products, will start adding a temporary tariff surcharge to all product orders shipped to the United States. The company, which sells a wide array of items from chemical reagents to centrifuges and syringe…
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STAT+: Autism evaluations are being canceled over fears about a national registry
STAT+: Autism evaluations are being canceled over fears about a national registry SEATTLE — Michael VanPelt spent several weeks recently glued to his telephone, dialing doctors who might be able to get his 3-year-old son in for an autism evaluation. The music teacher ran out of providers who took his health insurance, but luckily the…
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STAT+: Justice Department sues Medicare Advantage insurers and brokers, alleging kickbacks
STAT+: Justice Department sues Medicare Advantage insurers and brokers, alleging kickbacks The Department of Justice has sued three of the largest Medicare Advantage insurers and three dominant insurance brokerages, alleging a scheme in which the health insurers bribed the brokers to steer older adults into their policies. The lawsuit targets CVS Health’s Aetna, Elevance Health’s…
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STAT+: Collins and fellow GOP senators speak out in opposition to Trump’s cuts to biomedical research
STAT+: Collins and fellow GOP senators speak out in opposition to Trump’s cuts to biomedical research WASHINGTON — There was broad bipartisan support at a Senate hearing Wednesday to reverse course on the Trump administration’s cuts to federally funded biomedical research. Sen. Susan Collins (Maine), the Republican chair of the Senate Appropriations Committee, kicked off…
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Pharma tariffs, and a ‘sunshine day’ for biotech stocks
Pharma tariffs, and a ‘sunshine day’ for biotech stocks How did Ireland become a hotspot for pharmaceutical manufacturing? What are the products that will come out of Flagship’s latest startup centered around “preemptive medicine”? And who among the co-hosts is the best singer? We discuss all that and more on this week’s episode of “The…
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STAT+: Former Trump official warns president he’s at risk of ruining his legacy on ending HIV
STAT+: Former Trump official warns president he’s at risk of ruining his legacy on ending HIV WASHINGTON — The health official who helped convince President Trump during his first term that it’s possible to end the HIV epidemic in the United States is now imploring the president to stay the course, as funding cuts threaten…
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STAT+: Research grants as political ammo; Death to dyes?
STAT+: Research grants as political ammo; Death to dyes? You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. STAT won its first National Magazine Award for General Excellence. Not bad, huh? Help us…
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STAT+: NIH said to have halted awarding of new grants to top universities
STAT+: NIH said to have halted awarding of new grants to top universities Embattled universities whose funding from the National Institutes of Health has been frozen may face further financial strain as the agency holds off awarding new grants to at least half a dozen of them, according to an email obtained by STAT. The…
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STAT+: RFK Jr. is back to criticizing vaccines, and Trump’s new drug-cost plan
STAT+: RFK Jr. is back to criticizing vaccines, and Trump’s new drug-cost plan You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. I cast my leafy-green seeds already, and my mint, chives and…
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STAT+: Trump’s plans to lower drug prices have echoes of past efforts
STAT+: Trump’s plans to lower drug prices have echoes of past efforts WASHINGTON — The Trump administration has an expansive view for how it can lower drug prices for Americans. It has been here before. The question is whether this time will be different. During his first term, President Trump tried to tie U.S. drug…
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‘The same Bobby Kennedy’: How RFK Jr.’s vaccine criticism came rushing back
‘The same Bobby Kennedy’: How RFK Jr.’s vaccine criticism came rushing back WASHINGTON — Robert F. Kennedy Jr. downplayed his past criticism of vaccines as he sought to become the nation’s health secretary. Now, just two months after winning confirmation, he’s frequently returning to rhetoric from his time as perhaps the most prominent vaccine critic…
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RFK Jr. plans changes to vaccine injury reporting system
RFK Jr. plans changes to vaccine injury reporting system WASHINGTON — Health secretary Robert F. Kennedy Jr. said Tuesday that he plans to roll out changes to the vaccine injury monitoring system that would automate and increase data collection as well as look for negative impacts of the shots. Reforming the current Vaccine Adverse Event…
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STAT+: Trump administration launches probe into pharmaceutical imports
STAT+: Trump administration launches probe into pharmaceutical imports The Trump administration disclosed it formally opened an investigation into the extent to which the importation of certain pharmaceuticals may threaten national security, a move that is a widely anticipated prelude to imposing tariffs on a potentially large number of medicines. In a Federal Register notice published…
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STAT+: Canada advances an antitrust probe into Express Scripts over ‘patient steering’ and pharmacy fees
STAT+: Canada advances an antitrust probe into Express Scripts over ‘patient steering’ and pharmacy fees Canadian officials have obtained a court order that requires Express Scripts to produce documents in connection with an investigation into whether the pharmacy benefits manager violated antitrust laws. The Competition Bureau is examining whether the company forced or induced Canadians…
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STAT+: Trump to end federal funding of certain non-medical services in Medicaid
STAT+: Trump to end federal funding of certain non-medical services in Medicaid WASHINGTON — The Trump administration said Thursday that it will no longer help states fund non-medical services that often are aimed at improving housing and nutrition for people in the Medicaid program. The change is a departure from the Biden administration’s efforts to…
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STAT+: FDA plans to phase out animal testing in drugs in what it calls a ‘paradigm shift’
STAT+: FDA plans to phase out animal testing in drugs in what it calls a ‘paradigm shift’ In an unexpected move, the U.S. Food and Drug Administration announced plans this week to reduce — and possibly replace — animal testing with other methods for developing certain medicines in a bid to lower R&D costs and,…
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STAT+: Why the closure of an FDA office may impact generics manufacturers — and everyday Americans
STAT+: Why the closure of an FDA office may impact generics manufacturers — and everyday Americans Amid the hard-to-follow cutbacks at the U.S. Food and Drug Administration, a little-known but important office was eliminated — and the implications will be felt not only by drugmakers, but consumers. The Division of Policy Development in the Office…
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STAT+: RFK Jr.’s Senate hearing delayed, living with more measles
STAT+: RFK Jr.’s Senate hearing delayed, living with more measles You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. STAT is cutting the price of an annual subscription in half. Click here for…
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STAT+: Study shows how UnitedHealth uses coding to rake in extra cash from Medicare Advantage
STAT+: Study shows how UnitedHealth uses coding to rake in extra cash from Medicare Advantage Health insurers in the private Medicare business have a big incentive to diagnose their members with lots of health conditions: The government pays them more money. A new study shows the extent to which the biggest player in that business,…
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STAT+: Trump gives major lift to 2026 Medicare Advantage payments
STAT+: Trump gives major lift to 2026 Medicare Advantage payments Health insurers that sell Medicare Advantage plans are going to get about $30 billion more in taxpayer money next year. President Trump’s Medicare agency finalized a rule Monday that would raise benchmark payment rates to privatized Medicare plans by 5.1% for 2026. That was higher…
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Opinion: STAT readers on cadavers in med education, doctors and AI, and more
Opinion: STAT readers on cadavers in med education, doctors and AI, and more First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others. To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected…
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STAT+: Medicare gets a big (unofficial) surprise: a 17-year extension on when it’ll run dry
STAT+: Medicare gets a big (unofficial) surprise: a 17-year extension on when it’ll run dry Medicare’s financial future unexpectedly got a lot rosier, at least according to some federal budget wonks. The Congressional Budget Office recently published its long-term predictions of the federal budget and buried a big surprise for people who follow the Medicare…
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STAT+: FDA tells drugmakers to redo studies run by a contract research firm due to data integrity issues
STAT+: FDA tells drugmakers to redo studies run by a contract research firm due to data integrity issues In a rare move, the Food and Drug Administration told an unspecified number of drug companies that studies used to support therapeutic equivalence of some of their medicines have been rejected due to false data generated by…
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Cuts, ousters and drama at the FDA
Cuts, ousters and drama at the FDA Turmoil, job cuts and forced ousters of high-ranking officials at federal health agencies. Marty Makary’s rough first week as FDA Commissioner. Biotech stocks tumble even further. President Trump’s “Liberation Day” tariffs roil global markets. We talk about biotech’s volatile week, plus interview AstraZeneca R&D executive Sharon Barr, on…
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STAT+: Makary’s first speech to FDA staff focuses on challenging norms, fighting chronic disease
STAT+: Makary’s first speech to FDA staff focuses on challenging norms, fighting chronic disease WASHINGTON — Marty Makary’s first address to staff as FDA commissioner on Wednesday afternoon sounded a bit like an introduction to one of his books. It included sweeping declarations about the need to challenge scientific norms, and to identify the root…
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STAT+: FDA Commissioner Marty Makary gets off to a bruising start as agency is wracked by layoffs
STAT+: FDA Commissioner Marty Makary gets off to a bruising start as agency is wracked by layoffs WASHINGTON — Marty Makary’s first official day as commissioner of the Food and Drug Administration began with employees in tears, learning from security guards that they were losing their jobs. The news release announcing the start of his…
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STAT+: Cassidy gave himself a difficult task. RFK Jr. isn’t making it any easier on him
STAT+: Cassidy gave himself a difficult task. RFK Jr. isn’t making it any easier on him WASHINGTON — Sen. Bill Cassidy (R-La.) said he would be Robert F. Kennedy Jr.’s keeper, but the physician-turned-politician is struggling to stop the nation’s health secretary from undermining public trust in vaccines. Cassidy has taken the lead for his…
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STAT+: Texas judge strikes down FDA’s plan to regulate lab-developed tests
STAT+: Texas judge strikes down FDA’s plan to regulate lab-developed tests WASHINGTON — A federal judge in Texas squashed the Food and Drug Administration’s plan to regulate lab-developed tests on Monday, ruling in favor of lab trade groups that said the agency was overstepping its bounds. “The Court VACATES and SETS ASIDE, in its entirety,…
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Peter Marks, FDA’s top vaccine regulator, forced out
Peter Marks, FDA’s top vaccine regulator, forced out Peter Marks, the top Food and Drug Administration official who oversaw vaccines, gene therapies, and the blood supply, resigned Friday after being told by Trump administration officials he would be fired if he did not step down, according to people familiar with the situation. In his resignation…
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STAT+: Wyden claims Pfizer used a ‘colossal’ scheme to avoid paying billions in U.S. taxes
STAT+: Wyden claims Pfizer used a ‘colossal’ scheme to avoid paying billions in U.S. taxes In what one U.S. lawmaker described as possibly the “largest tax-dodging scheme” by a pharmaceutical company in history, Pfizer sold $20 billion in medicines to U.S. customers six years ago, but did not report any profits from those sales on…
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STAT+: HHS layoffs rile Democrats, but Republicans say they trust RFK Jr.’s cuts will not hamper core operations
STAT+: HHS layoffs rile Democrats, but Republicans say they trust RFK Jr.’s cuts will not hamper core operations WASHINGTON — News of massive layoffs at the Health and Human Services Department was met with anger and predictions of lawsuits by Democratic lawmakers, and with a shrug by Republicans. HHS Secretary Robert F. Kennedy Jr. announced…
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STAT+: RFK Jr. brings FDA under tighter control with HHS workforce cuts
STAT+: RFK Jr. brings FDA under tighter control with HHS workforce cuts WASHINGTON — Around 3,500 employees are on the chopping block at the Food and Drug Administration, but they don’t yet know who they are. The Health and Human Services Department on Thursday announced a sweeping plan to cut 10,000 jobs and consolidate operations…