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Politico
a day ago
- Politics
- Politico
Student visa rules threaten U.S. medical research
Presented by With Erin Schumaker and Robert King Driving The Day VISITING FELLOWS UNDER THREAT — The National Institutes of Health's visiting fellows program could be hit hard by the Trump administration's plan to review and revoke visas for international students, Erin reports. Last week, Secretary of State Marco Rubio said the State Department would 'aggressively revoke' visas for Chinese students and expand social media vetting for international students on exchange visas. Collaboration across borders: More than 2,000 scientists worldwide participate in the program conducting basic and clinical research at the NIH campus and in field units nationwide, according to the NIH website, which notes: 'The NIH has long considered close interaction with foreign scientists in the conduct of collaborative research to be an essential ingredient in achieving its objectives.' Sixty-eight percent of postdoc fellows at the NIH were part of the visiting fellows program last year, according to the NIH fellows union. 'This underscores the vital role international researchers play here at the NIH,' Marjorie Levinstein, a union representative, told Erin. 'International scholars, including those from China, are integral to research at the NIH and play essential roles in lifesaving research.' Rubio was unclear about which visa types would be targeted, but many of the fellows enter the country on exchange visas. Pausing interviews for those visas would halt onboarding fellows, and revoking them would send active fellows home, potentially disrupting hundreds of studies. Driving scientists to work elsewhere: Combined with the other challenges international postdocs face, like slashed research funding, canceled grants and layoffs, many question whether it's worth staying in the U.S., their colleagues say. Threatening visas could encourage international scientists to take jobs in other secure countries, according to Dr. Ross McKinney, professor emeritus of pediatrics at Duke University School of Medicine and former chief scientific officer at the Association of American Medical Colleges. U.S. institutions 'at the moment can barely make promises,' McKinney said, a dynamic that could play out this summer and fall as postdocs and Ph.D. students decide where to work. 'That money may not be there because of the way the NIH is being manhandled,' he added. What's next: The ripple effect of a diminished workforce could extend beyond the fellows program. 'When we wipe out the universities' abilities to do this research by cutting back so much on a critical workforce, it's only a matter of time before the pharma industry gets really nailed, too,' McKinney said. WELCOME TO MONDAY PULSE. I'm Carmen Paun, POLITICO's global health reporter, filling in today for Kelly. Can you believe it's June already? Send your surprise reaction, tips, scoops and feedback to cpaun@ and khooper@ and follow along @carmenpaun and @Kelhoops. ICYMI: The Conversation kicked off with Dr. Oz In the premiere episode of The Conversation, Dasha Burns sat down with Dr. Mehmet Oz — now leading the Centers for Medicare and Medicaid Services — for a candid talk on drug prices, potential Medicaid cuts and why he's getting early morning calls from President Donald Trump. Plus, POLITICO's Jonathan Martin dished on the Ohio governor's race (featuring Elon Musk, Vivek Ramaswamy and former Ohio State football coach Jim Tressel) and Kyle Cheney unpacked Trump's legal battle over 'Liberation Day' tariffs. In Congress THE BIG, BEAUTIFUL BILL — Congress returns this week, with the GOP domestic-policy megabill headed to the Senate, where an ideologically diverse group of Republicans is poised to have a big impact on the bill's final version. Ranging from conservative Josh Hawley of Missouri to centrist Susan Collins of Maine, the senators found rare alignment over concerns about what the House-passed bill does to Medicaid, and they have the leverage to force significant changes in the Senate, POLITICO's Jordain Carney reports. Other GOP senators, including Lisa Murkowski of Alaska, Jerry Moran of Kansas and Jim Justice of West Virginia, have also drawn public red lines over health care — and they have some rhetorical backing from President Donald Trump, who has urged congressional Republicans to spare the program as much as possible. Why it matters: Based on estimates from the nonpartisan Congressional Budget Office, 10.3 million people would lose Medicaid coverage if the House bill were to become law — many, if not most, in red states. That could spell trouble for Majority Leader John Thune's whip count. He can lose only three GOP senators on the expected party-line vote and still have Vice President JD Vance break a tie. But Kentucky Senator Sen. Rand Paul (R-KY) also plans to oppose the bill if it includes raising the debt limit. 'If I vote for the $5 trillion debt [limit increase], who's left in Washington that cares about the debt?' Paul said on CBS's 'Face the Nation' on Sunday. A WARNING — Health plans and state officials warn of 'immediate instability' for the Affordable Care Act's insurance marketplaces if a last-minute change to the House GOP's megabill becomes law, Robert reports. The policy could lead to higher premiums for people who shop on the ACA's insurance exchanges and leave brokers and insurers with little time to understand how it would affect the market before open enrollment starts this fall. The House's One Big Beautiful Bill Act would restart in 2026 federal payments to insurers that President Donald Trump canceled during his first term. But the payments are restricted for plans that cover abortions. Plans are legally required to cover abortions in 12 states and the District of Columbia. Insurers worry that the policy adds more uncertainty to an already chaotic market. Other pressing changes to the marketplaces include the looming expiration of enhanced premium subsidies and stricter eligibility changes, which could create 'immediate instability,' said lead insurance trade group AHIP. 'This policy, if coupled with inaction on extending the premium tax credits, will have the opposite effect, and lead to millions of Americans facing steep premium hikes for coverage in 2026,' spokesperson Tina Stow said in a statement. HEALTH FUNDING BUDGET CUT — The Trump administration seeks to cut the HHS budget next fiscal year by a third compared with current levels. The administration seeks $94.7 billion for fiscal 2026 — a decrease of about $31.3 billion from fiscal 2025. That includes cuts to most of America's health agencies, with the NIH seemingly poised for a 40 percent cut. That alarmed several health groups and Democratic lawmakers. 'Slashing federal research funding at a time when science is revolutionizing cancer care risks leaving millions of patients without the promise and potential of life-saving breakthroughs,' Dr. Clifford Hudis, chief executive director of the Association for Clinical Oncology, said in a statement. The association, which represents cancer doctors, was reacting to a proposed cut of some $2.7 billion in the National Cancer Institute's budget. 'You might as well gift wrap the future and hand it to China,' Sen. Patty Murray (D-Wash.), the top Democrat in the Senate Appropriations Committee, said in a statement about the proposed NIH cuts. OMB's take: Russ Vought, director of the Office of Management and Budget, defended the cuts to cancer research Sunday. 'It's more about the NIH, and the NIH has been a bureaucracy that we believe has been weaponized against the American people,' he told CNN. He then referred to the agency's funding of coronavirus research at China's Wuhan Institute of Virology, which many Republicans allege is where the pandemic started. Three U.S. government agencies — the Department of Energy, the FBI and the CIA — claim a lab leak caused the pandemic, but that theory has no scientific consensus. Many virologists back the theory that Covid-19 was caused by a spillover of the virus from animals to people. 'It's still important to have cancer research,' Vought said, adding that the administration wanted a strong NIH. But the money shouldn't go to funding universities' indirect research costs at levels higher than billionaire philanthropist Bill Gates' foundation allows, Vought argued. GLOBAL HEALTH SLASHED, TOO — Other groups are similarly concerned about the State Department's planned cuts to global health funding by more than 60 percent, as outlined in its budget, released Friday. The $3.8 billion budget request for fiscal 2026 focuses on preventing infectious diseases and 'providing lifesaving assistance to those suffering from HIV/AIDS, tuberculosis, polio, and malaria,' according to the State Department's Congressional Budget Justification. PEPFAR: The budget would allocate $2.9 billion to the President's Emergency Fund for AIDS Relief, down from $4.8 billion this year. The administration wants to phase out the program by focusing its 'resources only on the most cost-efficient, life-saving HIV treatment, and delivery models, and developing and executing country handover plans to transition towards greater recipient government responsibility and financing,' the State Department wrote. 'Congress must reject these deadly cuts,' said Asia Russell, executive director of Health GAP, a nonprofit working on access to HIV treatment in developing countries. However, the State Department intends to back targeted prevention campaigns that include using lenacapavir, a twice-a-year HIV injection the FDA is expected to approve this month. PEPFAR and The Global Fund to Fight AIDS, Tuberculosis and Malaria committed last year to securing its access for at least 2 million people over three years. But the State Department hasn't yet decided whether to continue support for The Global Fund, an international partnership. The U.S. has been its largest donor since it was founded in 2002. If the State Department decides to provide funding, the U.S. would limit its contribution to only a quarter of the fund's budget, it said. The U.S. contribution has typically been about a third of the its budget. Gavi: The State Department won't request funding for Gavi, the Vaccine Alliance, which helps low-income countries procure and deploy vaccines, because the organization is 'a Swiss NGO which reports a reserve of over $7.0 billion in its most recent statutory financial statements.' Other cuts: The State Department said its budget request 'eliminates funding for programs that do not make Americans safer, such as family planning and reproductive health, neglected tropical diseases, and non-emergency nutrition.' AROUND THE AGENCIES MAKARY TALKS VAX RECS — During a Sunday appearance on CBS's 'Face the Nation,' FDA Commissioner Marty Makary tried to clarify the federal government's Covid-19 vaccine recommendations for healthy children and pregnant women. Makary endorsed Health Secretary Robert F. Kennedy Jr.'s announcement last week that the shots would be removed from the list of recommended vaccines for the two groups. But later in the week, the CDC included the Covid vaccine on the children's immunization schedule with a note specifying that healthy children 'may' get the vaccine if their health care provider and parent or guardian believe they should. Asked why he didn't wait for the CDC's Advisory Committee on Immunization Practices to debate the change in recommendations, as in the past, Makary told CBS' Margaret Brennan, 'That panel has been a kangaroo court where they just rubber stamp every single vaccine put in front of them.' DR. OZ: CMS CAN HELP — Dr. Mehmet Oz, administrator for the Centers for Medicare and Medicaid Services, told POLITICO that his agency can help states implement work requirements introduced in the House-passed One Big, Beautiful Bill. Attempts by some states to introduce such requirements in the past led to some Medicaid beneficiaries losing their insurance because they failed to submit required paperwork, even when they complied with the work requirement. 'If the reason not to do something that we all think we should do is we don't think we're capable or competent to do it, that's a problem,' Oz told POLITICO's Dasha Burns. He said CMS would try to help states implement the requirements once they become law. The system should be available within a year, Oz said. WHAT WE'RE READING POLITICO's Alice Miranda Ollstein looks at how the Trump administration's targeting of legal immigrants threatens the health sector. STAT covers the FDA's approval of a next-generation Covid vaccine from Moderna, with restrictions. The Associated Press reports on how 'deep cuts erode the foundations of U.S. public health system, end progress, threaten worse to come.'
Politico
a day ago
- Politics
- Politico
It'll ‘be OK,' Trump says about student visas. Officials are skeptical.
Presented by National Association of Independent Colleges and Universities Driving The Day VISA TROUBLES: President Donald Trump's message to Chinese students who are worried about getting their visas revoked: It is all 'going to be OK.' — A series of moves from the administration last week has created a great deal of uncertainty for many international students. The State Department paused interviews for student visas, and Secretary Marco Rubio announced he'd revoke Chinese student visas, including for those working in 'critical fields' or with Communist Party ties. — 'They're going to be OK. It's going to work out fine,' Trump told reporters Friday night when asked what his message is to Chinese students. 'We just want to check out the individual students. We have to and that's true with all colleges.' — However, a State Department official familiar with consular issues, who was granted anonymity to speak freely, told POLITICO last week embassies hadn't received official instructions on how to implement Rubio's plan, which also includes revising visa criteria to increase scrutiny of future applicants from China and Hong Kong. — 'It's going to be a massive headache for us,' said one State Department official involved in the discussions about how to implement the directives. The person was granted anonymity to discuss sensitive internal processes. A broad pause: Those who represent the higher education community say the State Department's actions will deter international students from wanting to attend school in the U.S. The American Council on Education and 30-plus other organizations wrote a letter to Secretary Rubio laying out their concerns about the pause in student visa interviews. — 'As we have previously communicated, we stand ready to work with federal officials to address security concerns regarding any international students,' Ted Mitchell, president of ACE, wrote in a letter Friday on behalf of the groups. 'However, we are concerned that imposing a broad pause on all student — visas would send a message that our nation no longer welcomes talented students and scholars from other countries.' — The pause comes during peak visa season after students have already accepted admissions offers and put down deposits for the upcoming fall semester. Mitchell writes that the hiatus on interviews during this critical time will weaken colleges' ability to attract the 'best and brightest minds.' A swipe at Harvard: During his remarks on Friday, Trump also criticized Harvard, which is in a legal battle with administration over its ability to enroll international students. He said the school has not provided the government with enough information. Homeland Security Secretary Kristi Noem ordered the university to submit records on what she said were 'illegal' and 'violent' activities from international students. Harvard has called the administration's action to revoke its ability to enroll international students 'unlawful.' — 'We want people that can love our country and take care of our country and cherish our country and for some reason Harvard doesn't want to give us a list,' Trump said in reference to Noem's request. — Noem told Fox News on Sunday that Harvard 'perpetuates Chinese Communist Party priorities,' adding that Harvard supported students 'feeding information back to our enemy, which is Communist China.' — 'These ties to China are deeply alarming. It's not just Harvard,' she said. 'There are other universities and we're going though every single one of them.' IT'S MONDAY, JUNE 2. WELCOME TO WEEKLY EDUCATION. I'm your host, Rebecca Carballo. Let's talk: rcarballo@ The team: Bianca Quilantan at bquilantan@ Juan Perez Jr. at jperez@ and Mackenzie Wilkes at mwilkes@ ICYMI: The Conversation kicked off with Dr. Oz In the premiere episode of The Conversation, Dasha Burns sat down with Dr. Mehmet Oz — now leading the Centers for Medicare and Medicaid Services — for a candid talk on drug prices, potential Medicaid cuts and why he's getting early morning calls from President Donald Trump. Plus, POLITICO's Jonathan Martin dished on the Ohio governor's race (featuring Elon Musk, Vivek Ramaswamy and former Ohio State football coach Jim Tressel), and Kyle Cheney unpacked Trump's legal battle over 'Liberation Day' tariffs. Watch the full episode on YouTube. And don't miss a moment — subscribe now on Apple Podcasts or Spotify to get new episodes when they drop. Want to receive this newsletter every weekday? Subscribe to POLITICO Pro. You'll also receive daily policy news and other intelligence you need to act on the day's biggest stories. PK-12 'HARMFUL STEREOTYPES': Education Secretary Linda McMahon visited Massapequa High School to announce that her department's investigation found the New York State Board of Regents was in violation of Title VI. — The department launched an investigation in April into the board for threatening to withhold money from a local school district because of its chief mascot. Key Context: More than two years ago, New York state required school districts to eliminate mascots that appear to appropriate Native American culture or risk losing state funding. — 'The Trump Administration will not stand idly by as state leaders attempt to eliminate the history and culture of Native American tribes,' said McMahon. 'Rather than focus on learning outcomes, the New York Department of Education and Board of Regents has set its sights on erasing Massapequa's history – while turning a blind eye to other districts' mascots that are derived from or connected to other racial or ethnic groups.' — However, many Native American tribes and associations representing Indigenous people find such mascots to be offensive. The Association on American Indian Affairs condemns the use of Native sports team names, mascots, symbols and gestures. — 'Using these harmful stereotypes perpetuates a long history of uninformed depictions of Native Peoples and violence, as well as undermines the educational learning environment,' the group has said. AGENCY REVIEW FIRST IN WEEKLY ED: Dozens of groups representing student borrowers, veterans, union members and others, sent a letter to the Education Department asking for the agency to expand the number of negotiators for a student loan rulemaking process. — The department announced in April that it would use the regulatory process to make changes to various student loan programs. The groups are asking to include financial aid administrators, student loan borrowers in repayment, civil rights organizations and others as negotiators. — Today is the deadline to submit nominations for negotiators. The Department anticipates holding one session between June 30 and July 2 before issuing proposed and final rules later this year. MOVERS AND SHAKERS REFORMING: Amber Northern will serve as a senior adviser to the secretary tasked with reforming the Institute of Education Sciences, the Education Department said Friday. — IES, a nonpartisan research arm of the department that studies special education and student learning outcomes, among other topics, was one of the first targets of the so-called Department of Government Efficiency. — Northern will work with Matthew Soldner, acting director at IES, institute staff, and external experts and stakeholders. — 'It is such an honor to be asked to examine IES with fresh eyes and consider how it might be more responsive to the students, parents, and educators that it serves,' Northern said. 'I know that the education community values the role that the federal government plays in Research & Development and I look forward to working with them on this rebuild.' — Northern is on leave from her role as the senior vice president of research at the Thomas B. Fordham Institute, a right-leaning, education policy think tank. She oversaw the organization's research portfolio and staff. — Northern holds a Ph.D. in education policy and evaluation from the University of Virginia. She has served in an advisory capacity for various charter schools, federal assessment entities, and state education departments. Syllabus — M.I.T. class president barred from graduation ceremony after pro-Palestinian speech. The New York Times. — Why does Trump keep saying Harvard teaches remedial math? The Wall Street Journal. — Michigan Senate Democrats won't consider a trans athlete sports ban. Will Trump target the state? Chalkbeat Detroit.
Politico
4 days ago
- Business
- Politico
FDA denies ultra-rare drug but offers path to ‘yes'
Presented by With help from Chelsea Cirruzzo Driving The Day ANOTHER BLOW TO BARTH'S TREATMENT — The FDA rejected Stealth BioTherapeutics' latest bid to market its proposed treatment for an ultra-rare genetic condition, though regulators have suggested a 'path' toward accelerated approval, the company said Thursday. Stealth said the agency's complete response letter, which came four months after the FDA was initially scheduled to make a decision, didn't raise concerns with clinical safety data for the drug, known as elamipretide, to treat Barth syndrome by targeting underlying dysfunction in mitochondria, which are small energy-producing structures in cells. CEO Reenie McCarthy told Prescription Pulse that agency requests for additional data in late 2024 led the biotech to expect approval, and the biotech believes they should have gotten accelerated approval based on what the FDA conveyed in the letter. 'They have all the information they need to make that decision,' she said. HHS didn't respond to a request for comment. Background: Barth syndrome — which can cause an enlarged and weakened heart, muscle weakness, recurrent infections and delayed growth — typically affects males and shortens their life expectancy by decades. About 150 Americans have the condition. Stealth had suggested two ways the FDA could consider approving elamipretide — granting full approval based on the company's natural history study of disease progression absent medical intervention or endorsing accelerated approval based on a trial suggesting long-term improvements in muscle function. The FDA has agreed to consider muscle strength around the knees as a potential intermediate marker by which it could support accelerated approval and has asked Stealth to resubmit its application based on that endpoint, McCarthy said. External FDA advisers voted last year to recommend approval for elamipretide despite persistent questions about its effectiveness. Stealth, rare disease advocates and patients with Barth syndrome and their caregivers have advocated for years for FDA approval, highlighting the difficulties in conducting trials for potential rare disease treatments that can't be studied in large populations. Thursday's rejection seems 'inconsistent' with FDA Commissioner Marty Makary's recent comments about approving rare disease therapies based on plausible mechanisms and patient demand, McCarthy said. 'There's a bit of a disconnect' between those statements and the FDA's feedback, she said. What's next: Stealth expects to meet with the FDA next month to discuss a postmarketing study it proposed in 2022 and 'gauge how serious they are,' McCarthy said. The company laid off 30 percent of its staff to save money for a potential FDA resubmission and to maintain elamipretide access for critically ill patients under the agency's compassionate use pathway. McCarthy also raised concern about the FDA's stance that an accelerated approval would make the drug inappropriate to administer to newborns in acute cardiac distress, a population she said makes up two-thirds of Stealth's expanded access program. Half of early Barth syndrome deaths occur by age 1, per the company. IT'S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Do you work at HHS? We want to learn more about the decision to cancel Moderna's bird flu vaccine funding. Send your tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). Eye on the FDA REPLACING COLOR ADDITIVES IN MEDS — The FDA quietly released draft recommendations for drugmakers that want to replace color additives in their approved drugs — potentially hinting at where the Trump administration will next focus HHS Secretary Robert F. Kennedy Jr.'s Make America Healthy Again energies. The agency acknowledged that changing the formulation of a drug — including its inactive ingredients — is generally considered a major change. But the agency said replacing a color additive with another already listed in the FDA's color-additive regulations in many cases 'is unlikely to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product.' Replacing a color additive can 'generally be considered a moderate change' that can be requested via a 30-day supplement known as a CBE-30, according to the draft guidance published Thursday. 'If a manufacturer or an applicant intends to use a color additive that is not already listed in FDA's color additive regulations for the particular use, a petition must be sent to the Human Foods Program,' the draft guidance says. 'If FDA finds the color additive safe and suitable for such use, the additive will be listed in the color additive regulations.' What's next: The FDA is taking comments on the draft guidance for 60 days. AROUND THE AGENCIES LAYOFFS ON HOLD — CDC layoffs planned for early June are being paused in the wake of a preliminary injunction, two employees at the agency, granted anonymity for fear of retribution, confirmed to POLITICO's Sophie Gardner. CDC employees who were sent termination notices in April received an email from the agency's Office of Human Resources on Thursday, informing them that, because of a preliminary injunction, HHS 'is staying further action on any existing Reduction in Force (RIF) notices, including final separation of employees, at this time.' The laid-off employees will remain on paid administrative leave 'or in their current employment status' until further notice, the email said. An HHS spokesperson did not immediately respond to a request for comment. Background: On April 1, amid a massive restructuring of HHS, around 18 percent of the CDC's workforce received termination notices. But legal challenges have complicated the reduction in force and the HHS reorganization, meaning the vast majority of those employees are still technically employed at the CDC, with most remaining on administrative leave. Key context: On May 22, Judge Susan Illston of the federal district court in San Francisco issued a preliminary injunction that bars the administration from carrying out the reduction in force across 22 agencies — including HHS — that are defendants in the case. Federal employee unions, nonprofits and local governments are the plaintiffs. The email sent to CDC employees cites Illston's injunction as the reason for the decision. PROOFREADER WANTED — The White House blamed 'formatting issues' for errors in the citations of the recently released Make America Healthy Again report after a media report found studies in it that do not exist. 'We have complete confidence in [Secretary Robert F. Kennedy Jr.] and his team at HHS. I understand there were some formatting issues with the MAHA report,' White House press secretary Karoline Leavitt said Thursday. Her remarks came after NOTUS reported that seven of the sources cited in the report, which said children's health is in crisis and blamed chemicals, lack of exercise and ultraprocessed foods, don't exist. The report now lists five of its citations as 'corrected' or 'updated,' though that doesn't include the citations NOTUS reported as false. 'Some of the hundreds of citations in the report were formatted incorrectly or mistakenly referenced something other than what was actually intended,' a White House spokesperson told Pulse. 'That said, the content of the report is fully substantiated, and there is nothing in there that cannot be backed up; we did not conjure up any facts. Report has been corrected now.' Pharma Moves Laura Akowuah has joined Cooley as special counsel. She previously worked at the FDA for more than a decade in enforcement roles. Document Drawer The FDA approved Eton Pharmaceuticals' hydrocortisone oral solution Wednesday as a replacement therapy in patients ages 5 and older with adrenocortical insufficiency. WHAT WE'RE READING POLITICO's Erin Schumaker spoke with Dr. Wafik El-Deiry, a Brown University cancer researcher, about his campaign to lead the National Cancer Institute amid NIH funding cuts. Two pharmacy benefit managers filed lawsuits Thursday challenging a recently passed Arkansas law they say would force pharmacies across the state to close, Modern Healthcare's Hayley DeSilva writes. Texas lawmakers have sent legislation to Republican Gov. Greg Abbott's desk that would make it easier for parents to start the process of exempting their children from school vaccine mandates, The Associated Press' Jim Vertuno reports. Several House Republicans are raising concerns about broad pharmaceutical tariffs potentially being placed on the industry, POLITICO's Ari Hawkins reports.
Politico
6 days ago
- Health
- Politico
CDC's Covid shot shift for pregnant women slammed
Presented by With help from Ruth Reader Driving The Day COVID VAX PUSHBACK — The Trump administration's decision to pull the Covid-19 vaccine from the CDC's list of recommended shots for healthy pregnant women was immediately questioned by public health groups that say the immunization is a critical tool to protect mothers and newborn infants. HHS Secretary Robert F. Kennedy Jr. also said the CDC would no longer recommend the shots for healthy children — a position that drew less criticism — but opened questions about whether access to the shots could erode. 'We're now one step closer to realizing President Trump's promise to make America healthy again,' Kennedy said in a video posted on social platform X, standing beside FDA Commissioner Marty Makary and NIH Director Jay Bhattacharya. It also bucks the recommendations of several European countries, ranging from Denmark to France, and the World Health Organization. Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said the group is concerned and extremely disappointed by the decision. He pointed to data showing that newborns can benefit from maternal antibodies from the vaccine for protection from Covid. 'In fact, growing evidence shows just how much vaccination during pregnancy protects the infant after birth, with the vast majority of hospitalized infants less than 6 months of age — those who are not yet eligible for vaccination — born to unvaccinated mothers,' Fleischman said. The Society for Maternal-Fetal Medicine said it will continue to recommend that pregnant patients take the Covid vaccine because surveillance data 'clearly demonstrates the safety and efficacy of mRNA vaccines in pregnancy.' 'Maternal immunization is proven to protect patients and their infants against severe illness and death from infectious diseases,' the group, a medical professional society for obstetricians, said in a press release. Insurance companies typically align their coverage decisions with the recommendations from the CDC and its outside panel of vaccine advisers. But the Advisory Committee on Immunization Practices did not vote on the change announced by Kennedy on Monday. AHIP spokesperson Tina Stow said the insurer trade group is 'reviewing today's announcement closely' when asked whether any insurers it represents plan to alter coverage of the Covid vaccine. On Capitol Hill, the decision was also questioned by a top Democrat. 'This reckless decision by the Trump Admin will make it harder for people to access the vaccine, but not impossible or illegal,' Rep. Frank Pallone (D-N.J.), ranking member of the Energy and Commerce Committee, posted on X. 'Please talk to your doctor and health care providers about your options.' IT'S WEDNESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Do you have insight into how the decision to alter the CDC's vaccination schedule was made? Send your tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). Eye on the FDA MAKARY LAUNCHES PHARMA TOUR — The Trump administration hasn't endeared itself to the pharmaceutical industry — but FDA Commissioner Marty Makary and other top agency officials are kicking off a national tour to meet with drugmaker executives next week at the agency's headquarters. The series of meetings will be held in major biotech cities across the U.S. — think Boston, New York, San Diego and San Francisco — in the coming weeks. The goal? Meeting with the executives to get input on 'how the FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies.' The FDA is collecting registrations from firms with at least one investigational new drug, new drug application or a biologics license application actively on file. Makary is bringing his number two, FDA Principal Deputy Commissioner Sara Brenner, and top vaccine regulator Vinay Prasad to the meetings. AI ON THE MIND — The FDA has brought on Dr. Shantanu Nundy, former chief medical officer for care navigator Accolade Health, to lead its artificial intelligence policy work, Ruth reports. Nundy is the latest addition to the agency's growing roster of AI leadership. The FDA has already hired senior adviser Jeremy Walsh, formerly of government contractor Booz Allen Hamilton, to lead the FDA's broader AI efforts. It also rehired Sri Mantha, former director of the Center for Drug Evaluation and Research's Office of Strategic Programs, after he was cut as part of President Donald Trump's reduction in force. Now, Nundy has joined as a contractor to lead development of FDA's AI-related guidance and regulations. Nundy, a primary care physician who studied medicine at Johns Hopkins University, has known Makary for some 20 years. The two wrote an op-ed in 2021, arguing that the CDC was not adequately guiding businesses on how to safely bring staff back to work. Separately, Nundy has advocated for making data from the CDC's vaccine-safety reporting platform V-safe, public to help combat vaccine hesitancy. He has spent much of his career in startups trying to bring the health care industry into the digital age. Before Accolade, he was director of the nonprofit arm of the Human Diagnosis Project, an Andreessen Horowitz-backed platform where doctors can consult one another on medical diagnoses and treatments. Research Corner KENNEDY BASHES MEDICAL JOURNALS — HHS Secretary Kennedy has threatened to stop government scientists from publishing their work in major medical journals as part of his escalating war on institutions he says are influenced by pharmaceutical companies. Speaking on the 'Ultimate Human' podcast Tuesday, Kennedy said The New England Journal of Medicine, JAMA and The Lancet, three of the most influential medical journals in the world, were 'corrupt' and publish studies funded and approved by pharmaceutical companies. The remarks come after FDA Commissioner Makary chose to publish a framework for how his agency will review Covid vaccines moving forward in NEJM last week. It also comes after JAMA and NEJM received letters from the Department of Justice probing them for partisanship. A JAMA spokesperson said the journal had nothing to add when asked about Kennedy's remarks, while NEJM and The Lancet did not respond to requests for comment. HHS also did not respond to requests for comment. WHAT WE'RE READING Young scientists are reconsidering their career opportunities and abandoning research amid drastic cuts to NIH grants, The Boston Globe's Chris Serres and STAT's J. Emory Parker report.
Politico
6 days ago
- Health
- Politico
States take the reins on insurance reform
Presented by Driving The Day STATE CRACKDOWN — Congressional lawmakers have tried and failed several times to push through a bipartisan, health-industry-backed bill that would speed up health insurers' prior authorization processes for certain prescription drugs and medical services. Congress will launch another attempt this year, but a growing number of blue and red states have taken the matter into their own hands. In 2024, at least 10 states passed laws to reform the prior authorization process, according to a report from the American Medical Association. Insurers use prior authorization to control costs. The state action continues to increase in 2025. Within the past few months, states including California, Connecticut, Hawaii, Iowa, New Jersey, North Carolina and North Dakota have either proposed or enacted reforms aimed at simplifying and streamlining prior authorization. And other states, including Illinois, Georgia, Texas, Rhode Island, Minnesota and Florida, have proposed cracking down on the use of artificial intelligence in prior authorization decisions. Why it matters: The uptick in state prior authorization reforms comes as health insurers have come under intense public and congressional scrutiny over how often they deny care, especially in the wake of the fatal shooting of UnitedHealthcare CEO Brian Thompson in December. The use of AI to deny care has also put insurers in the hot seat, with UnitedHealth Group facing a lawsuit over allegations that it used AI to wrongfully deny care to Medicare Advantage patients. The state reforms also come amid a lack of congressional action on the issue, despite widespread bipartisan and industry support for reforming the prior authorization process, which can sometimes be slow and administratively burdensome — impeding patients' access to necessary medical care. Even so: State power to regulate prior authorization is limited. While states have considerable authority over insurance companies operating within their markets, the federal government has jurisdiction over self-insured employer health plans and Medicare Advantage plans. 'State action is important, but it's not complete without federal action in some ways, because it's a federal requirement for employers, for self-insured and for Medicare Advantage plans, that state activity is not going to touch them,' said Kaye Pestaina, director of KFF's Program on Patient and Consumer Protections. Background: Last week, bipartisan lawmakers in the House and the Senate reintroduced the Improving Seniors' Timely Access to Care Act — a bill that would streamline prior authorization for older adults enrolled in Medicare Advantage. Despite widespread support from lawmakers, providers, doctors and insurers — and estimated to cost $0 by the last Congress — the repeatedly introduced bill has yet to pass. WELCOME TO WEDNESDAY PULSE. A new study found that teens living in areas with more access to cannabis retailers face significantly higher rates of mental health issues. Send your tips, scoops and feedback to khooper@ and ccirruzzo@ and follow along @Kelhoops and @ChelseaCirruzzo. At the Agencies A THREAT TO MEDICAL JOURNALS — HHS Secretary Robert F. Kennedy Jr. is escalating his war on institutions he says are influenced by pharmaceutical companies, Chelsea reports. On Tuesday, Kennedy, speaking on the 'Ultimate Human' podcast — a show hosted by a longevity expert that focuses on optimizing health — threatened to stop government scientists from publishing their work in major medical journals, including The New England Journal of Medicine, JAMA and The Lancet. He said the influential medical journals are 'corrupt' and publish studies that pharmaceutical companies fund and approve. 'Unless those journals change dramatically, we are going to stop NIH scientists from publishing in them, and we're going to create our own journals in-house,' he said. NIH is the world's largest funder of health research. Key context: Kennedy's comments come days after his Make America Healthy Again Commission released a report saying overprescribed medications could be driving a rise in chronic disease in children, suggesting the pharmaceutical industry has an outsize influence on doctors and scientists. It also comes after both JAMA and NEJM received letters from the Department of Justice probing them for partisanship. A JAMA spokesperson said the journal had nothing to add when asked about Kennedy's remarks, while NEJM and The Lancet did not respond to requests for comment. HHS also did not respond to requests for comment. Even so: Kennedy's stance conflicts with that of his NIH director, Dr. Jay Bhattacharya, who recently told a reporter with POLITICO sister publication WELT that he supports academic freedom, which 'means I can send my paper out even if my bosses disagree with me.' UPPING STATE OVERSIGHT — The Centers for Medicare and Medicaid Services is warning states against using federal dollars to pay for the health care of undocumented immigrants. In a Tuesday letter, the agency notified states it's ramping up financial oversight of state Medicaid expenditures to comply with President Donald Trump's executive order on 'Ending Taxpayer Subsidization of Open Borders.' The increased oversight includes 'focused reviews' of certain state spending reports and in-depth reviews of state financial management systems. The agency will also review eligibility rules in federal regulations and 'be proposing revisions as may be necessary.' 'Medicaid is not, and cannot be, a backdoor pathway to subsidize open borders,' said CMS Administrator Mehmet Oz in a news release. 'States have a duty to uphold the law and protect taxpayer funds. We are putting them on notice — CMS will not allow federal dollars to be diverted to cover those who are not lawfully eligible.' Key context: Undocumented immigrants are generally not eligible for Medicaid, though some states have used state-only funds to expand coverage to noncitizens. The increased oversight from CMS comes as Republicans' 'big, beautiful bill,' which passed the House, includes a provision that would penalize states that have expanded Medicaid coverage to undocumented immigrants by reducing the federal matching rate for the Medicaid expansion population for those states. Vaccines CDC'S COVID VAX CHANGE — The CDC no longer recommends that 'healthy' children and pregnant women receive the Covid-19 vaccine, a controversial change that's perplexed some public health experts, POLITICO's Sophie Gardner and David Lim report. On Tuesday, HHS Secretary Robert F. Kennedy Jr. announced the guidance change in a post on social media platform X, saying 'it's common sense and it's good science.' 'We're now one step closer to realizing President Trump's promise to make America healthy again,' Kennedy said in a video, standing beside FDA Commissioner Marty Makary and NIH Director Jay Bhattacharya. Kennedy cited 'a lack of any clinical data to support the repeat booster strategy in children.' Background: The CDC had recommended the vaccine for everyone at least 6 months old. Kennedy has long maintained that Covid vaccines aren't safe, despite the medical consensus that they are. Most Americans have stopped getting Covid vaccines. The most recent CDC data says about 1 in 8 children under 18 have received the latest shot, while fewer than 1 in 4 adults ages 18 and older have. Key context: The change bucks the CDC's precedent for updating vaccine recommendations, which typically takes place after a panel of experts votes on proposed changes. 'I'm disturbed for a couple reasons,' said Dr. Georges Benjamin, executive director of the American Public Health Association, which represents public health workers. 'I don't believe that they followed the normal process whereby you bring the advisory committees into this decision.' Other experts raised concerns about the public health implications of the decision. 'I'm perplexed by this decision,' said Mark Turrentine, an OB-GYN and professor at Baylor College of Medicine in Houston. 'A lot of pregnant people died of Covid, especially during the Delta wave. And we know Covid still hasn't gone away. And we know pregnant people are a high-risk group. And we have a lot of data that the vaccine provides strong protection for both the mother and the baby.' WHAT WE'RE READING POLITICO's Victor Goury-Laffont reports on France advancing an assisted-dying bill in a historic vote. STAT's Jason Mast reports on what one child's success story means for the CRISPR gene-editing industry.
