Latest news with #ACIP-recommended
The Hill
29-07-2025
- Health
- The Hill
Senate Democrats launch investigation into RFK Jr. firing of CDC vaccine panel
Democrats on the Senate Health Committee launched an investigation on Tuesday into Health and Human Services Secretary Robert F. Kennedy Jr.'s firing of all members of a Centers for Disease Control and Prevention (CDC) vaccine advisory panel. Led by ranking member Sen. Bernie Sanders (I-Vt.), who caucuses with Democrats, the lawmakers asked for detailed information about why Kennedy dismissed members of the CDC's Advisory Committee on Immunization Practices (ACIP), who else was involved in the process, and how the new members were identified and vetted. 'By removing all 17 of ACIP's members and replacing them with eight individuals handpicked to advance your anti-vaccine agenda, you have put decades of non-partisan, science-backed work— and, as a result, Americans' lives—at risk,' the lawmakers wrote. In June, Kennedy fired all members of the panel in an unprecedented escalation of his quest to reshape federal health agencies and vaccine policy. He then handpicked eight replacements, many of whom are vaccine critics. He accused the panelists of being beholden to corporate interests and said the panel was rife with conflicts, but did not provide any evidence. The panelists are not political appointees. ACIP members meet and discuss data to determine which vaccines are recommended and for whom. If the CDC director signs off on the panel's recommendations, ACIP-recommended vaccines must be covered by health insurance. Under many state laws, ACIP-recommended vaccines are mandated for schoolchildren. The lawmakers on Tuesday called on Kennedy to provide information on the firings by Aug. 12, including details of the alleged conflict of interest for each fired member and how their conflicts differ from ones they previously disclosed. Kennedy has promised transparency and department officials pledged to release ethics forms on the new panelists prior to their meeting last month, but that never happened. A searchable database of ACIP members lists conflicts of interest for just two of Kennedy's picks, though it's much more detailed for the dismissed members. The senators also asked if Kennedy plans to appoint any additional members to the panel. Only seven members participated in last month's meeting. Kennedy claimed in a Fox News interview in June that he would allow Health Committee chairman Sen. Bill Cassidy (R-La.) to place one of his own candidates on the panel. In addition to Sanders, the letter was signed by Democratic Sens. Tim Kaine (Va.), Maggie Hassan (N.H.), John Hickenlooper (Colo.), Ed Markey (Mass.), Andy Kim (N.J.), Lisa Blunt Rochester (Del.) and Angela Alsobrooks (Md.). The lawmakers said they launched a partisan investigation because a Sanders request for a bipartisan inquiry in June went unheeded. Cassidy on Tuesday said he doesn't see the point in an investigation, because Democrats will be able to question Kennedy directly the next time he testifies. 'The Secretary will be back before us. He's been before us once. He's going to be back before us again,' Cassidy told reporters. 'I'm not sure what an investigation is going to accomplish, more than the guy who apparently made the decision, sitting there before us, taking questions from everybody on the panel,' he continued.
Politico
07-07-2025
- Health
- Politico
Doctors' groups sue Kennedy over Covid shot changes for kids, pregnant people
Organizations on the challenge include the American College of Physicians, the American Public Health Association and the Infectious Diseases Society of America. The directive, they wrote, has put doctors 'in the untenable position of telling their patients that the country's top-ranking government health official's advice and recommendations are wrong and that we are right.' 'This erodes trust, which is the foundation of a healthy physician-patient relationship and vital to the success of AAP members' medical practices,' they added. Kennedy announced the change in a May 27 video posted to X , in which he was flanked by FDA Commissioner Dr. Marty Makary and NIH Director Dr. Jay Bhattacharya, both of whom gained notoriety during the Covid pandemic for their opposition to mask and vaccine mandates. The three officials said there wasn't sufficient data to show healthy children and healthy pregnant women benefited from Covid vaccination. 'Most countries have stopped recommending it for children,' Makary said in the video. The administration later distributed a document explaining the decision to lawmakers. The document said studies have shown that women who got the vaccine during pregnancy had higher rates of various complications, but authors of those studies told POLITICO that the administration had misinterpreted their results. The plaintiffs in the case said Kennedy had unlawfully sidelined the CDC and its independent vaccine panel, the Advisory Committee on Immunization Practices, which are the federal bodies responsible for the immunization schedule. 'The statutory scheme that regulates the vaccine infrastructure in this country demonstrates Congress' repeated policy decision to require that ACIP recommendations, made by a fairly balanced ACIP membership, 51 be the basis for what is put on or taken off of the CDC immunization schedules — not the unilateral decision of a single individual,' the plaintiffs wrote. Public and private insurers are largely obligated to cover ACIP-recommended vaccines with no cost-sharing under the Affordable Care Act, and states often tie their daycare and school vaccine requirements to the panel's recommendations. While the CDC ultimately didn't pull the recommendation from the childhood schedule, it did downgrade it to one involving 'shared decisionmaking' — a differentiation the physician groups say has made it harder for providers to counsel patients and for practices to assess insurance coverage. The lawsuit was filed in federal district court in Massachusetts, where a landmark vaccine policy case set national precedent in the early 20th century. The Supreme Court's 1905 Jacobson v. Massachusetts decision upheld states' authority to mandate vaccinations.
Politico
25-02-2025
- Health
- Politico
Could ACIP delay wind up in court?
Driving The Day ACIP LEGAL FALLOUT — The Trump administration's delay of what was supposed to be this week's regularly scheduled meeting of the CDC's vaccine advisers — and its anticipated overhaul of the panel — raised questions about what legal recourse drug companies and others might have. As we've reported since now-HHS Secretary Robert F. Kennedy Jr.'s star rose with President Donald Trump's electoral win, the department head has vast discretion to remake the Advisory Committee on Immunization Practices — and Kennedy plans to replace at least some of them because of perceived conflicts of interest. But it may not be so simple. The CDC typically adopts the ACIP's recommendations, which have become an integral step in ensuring both clinical use and insurance coverage of newly approved vaccines. References to the committee and its expected actions have been baked into federal and state laws — 2016's 21st Century Cures Act directs the panel to consider any new vaccines or indications at its next meeting following FDA approval, and 2022's Inflation Reduction Act requires ACIP-recommended shots covered under Medicare Part D to be offered at no cost to beneficiaries. ACIP also votes on whether a pediatric vaccine should be added to the Vaccines for Children program, which offers shots at no cost to low-income kids. 'A court should most certainly look at the history and the context in addressing any action' that affects the committee's work, said Richard Hughes IV, a lawyer at Epstein Becker Green and a former Moderna executive. Who has standing? While the FDA licenses new vaccines for the U.S. market, insurance coverage policies are usually tied to the ACIP's recommendations for their use. That means any delay to committee votes can have a material impact on uptake. 'How many doctors would consider recommending a $100 vaccine without professional [CDC] recommendation?' said Dorit Reiss, a vaccine law expert at the University of California College of the Law. A spokesperson for GSK, which had two products slated for ACIP votes this week, didn't comment on whether the company would consider legal action over the meeting delay. Is that your final answer? Any groups itching to get litigious would have to argue that the scrapping of the ACIP meeting is a 'final agency action.' HHS' statement asserted that the cancellation is a 'postponement' to ensure the public has adequate time to comment before the meeting. While that likely buys the administration some time, drugmakers and others who want to see ACIP continue to make recommendations might have to decide at some point that the delay has morphed from temporary to indefinite — and thus a 'final' action. 'It's really hard to sue against nonaction, which is what this is,' Reiss said. Reiss noted that the ACIP's next meeting is scheduled for June. 'How far can you postpone it without actually canceling it?' she asked. 'There's only a limited time they can claim this.' IT'S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Finally, some nice weather in the nation's capital. Send your tips to David Lim (dlim@ or @davidalim) and Lauren Gardner (lgardner@ or @Gardner_LM). In the Courts COMPOUNDERS STRIKE BACK — The FDA is on the receiving end of a new lawsuit from a group representing large facilities that make copies of brand-name drugs, which sued Monday over the agency's removal of diabetes and weight-loss drug semaglutide from its shortage list. The Outsourcing Facilities Association, which has also challenged a similar agency decision for another weight-loss drug, argues that the FDA has ignored evidence that patients still have trouble accessing the drug and points to a recent financial disclosure from the manufacturer admitting that 'supply constraints' will continue. As in its earlier suit challenging the removal of the GLP-1 tirzepatide from the shortage list, the association maintains the FDA should have conducted notice-and-comment rulemaking before changing the drug's status. 'An agency exhibiting due regard for law would have awaited the Court's forthcoming ruling before engaging in a similar delisting action to ensure its acts complied with law,' OFA said in the filing with a federal district court in Texas. 'FDA deliberately chose action to harm millions of patients without the benefit of this Court's ruling.' The FDA didn't immediately respond to a request for comment. Industry Intel CAVAZZONI HEADS BACK TO PFIZER — Cue the revolving door debate. Just over a week after HHS Secretary Robert F. Kennedy Jr. took office, the longtime pharmaceutical skeptic was dropped a political gift: Former top FDA drug regulator Patrizia Cavazzoni is headed to Pfizer to be its chief medical officer. Before joining the FDA in January 2018 as the deputy director of operations in the agency's Center for Drug Evaluation and Research, Cavazzoni worked at Pfizer leading clinical sciences and development operations. The move, which Kennedy's allies quickly seized on as an example of an improper relationship the FDA has with the industry it is tasked with regulating, also drew fire from those opposed to Kennedy. Sen. Elizabeth Warren (D-Mass.) — a critic of Kennedy's vaccine skepticism — slammed the move as a poor decision by Cavazzoni that could erode trust in the FDA. 'When government officials cash in on their public service after leaving office, it degrades public trust and raises doubts about government's ability to work for people,' Warren said. 'That's why I've been so concerned about President Trump's picks with deep industry ties like RFK Jr. and Dr. Oz, and why I've pushed so hard to lock the revolving door.' But former FDA Commissioner Robert Califf described Cavazzoni on Monday as a 'dedicated civil servant' who 'knows as much about drug development and drug safety as anyone on Earth.' 'Perhaps she retired because she saw the behavior of the current administration coming,' Califf told POLITICO. 'I'm glad her skills will be used to help people suffering from disease.' Eye on the FDA WAIT WAIT ... WE WANT YOU BACK — Several FDA employees have been asked to return to their jobs after being fired by the Trump administration, including medical device reviewers and people involved with inspections, according to four people familiar with the decision and granted anonymity to discuss the calls. The reversal comes after the medical device industry raised concerns that the firings could delay the FDA's ability to review its products. Spokespeople for the FDA and the White House did not respond to requests for comment. In the Courts PBMS APPEAL FTC CASE — The three largest pharmacy benefit managers on Friday appealed a district court loss that allowed the Federal Trade Commission's complaint against the companies' insulin pricing practices to move forward. The pharmacy middlemen kicked their bid for a preliminary injunction up to the Eighth Circuit appellate court after a federal judge in Missouri denied their first attempt, determining the FTC was acting based on its congressional mandate. The FTC sued those entities, which negotiate drug prices on insurers' behalf, in September, arguing they've illegally maximized profits by steering patients to more expensive insulins. PBMs have argued they play an integral role as a counterparty against manufacturers to push down drug costs. Document Drawer Medicare Part D spending on 10 diabetes drugs increased 364 percent from $7.7 billion in 2019 to $35.8 billion in 2023, according to an HHS Office of Inspector General report released Monday. WHAT WE'RE READING Elizabeth Holmes lost an appeal to overturn her conviction, The Wall Street Journal's Meghan Bobrowsky reports. House Energy and Commerce Democrats plan to force votes on members' support for Medicaid during a markup today of the panel's oversight plans — the same day the chamber is slated to vote on a budget resolution that would direct the panel to cut from programs under its jurisdiction, POLITICO's Ben Leonard reports.
Yahoo
21-02-2025
- Health
- Yahoo
HHS postpones meeting of key CDC vaccine panel, one week after RFK Jr. sworn in
The first meeting of a Centers for Disease Control and Prevention (CDC) vaccine advisory committee since Robert F. Kennedy Jr. was sworn in as Health and Human Services (HHS) secretary has been postponed, the department confirmed. The Advisory Committee on Immunization Practices (ACIP) was set to meet Feb. 26-28 to discuss and vote on multiple vaccine issues, including recommendations for the use of a meningitis vaccine in infants and new recommendations on influenza and RSV vaccines. There was no time frame given for when the meeting would be rescheduled. 'The ACIP meeting will be postponed to accommodate public comment in advance of the meeting,' HHS spokesperson Andrew Nixon said in an email. 'The ACIP workgroups met as scheduled this month and will present at the upcoming ACIP meeting.' The ACIP convenes three times a year to advise the CDC on vaccine issues, but the agency doesn't have to follow the recommendations. However, if the CDC director signs off on the panel's recommendations, ACIP-recommended vaccines must be covered by health insurance. ACIP members aren't government employees. The panel includes up to 18 voting members representing clinical medical fields as well as public health professionals and at least one consumer representative. Members of the public can submit comments online through an official portal for two weeks ahead of the meeting, as well as register for a lottery to make comments live during the meeting. But the online portal was never activated, leaving the public unable to submit comments. The postponement comes amid growing fears about the panel's future under an HHS led by Kennedy, one of the country's most prominent anti-vaccine activists. Kennedy and his allies have long alleged ACIP members are corrupting HHS's research priorities through conflicts of interest, and during his confirmation hearing he pledged to root out conflicts of interest. An executive order issued by President Trump on Wednesday also targets federal advisory committees for review and possible termination 'on [the] grounds that they are unnecessary,' including ACIP. As of early Thursday afternoon, ACIP members were not notified of any changes to the meeting schedule, according to Dr. H. Keipp Talbot, the panel's chair. The Partnership to Fight Infectious Disease and 50 medical organizations and experts, including the American Medical Association, sent a letter to Kennedy and acting CDC Director Susan Monarez urging them to reschedule the meeting as soon as possible. 'Making America healthy requires healthy discussion and timely, evidence-based decisions. This meeting should be no different,' they wrote. 'Rescheduling this critical meeting … would represent a meaningful early follow-through from the Trump administration and its new HHS Secretary to ensure Americans receive the information needed to protect themselves against vaccine-preventable illnesses, confirming immunization's importance in the mission to make America healthier.' Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
20-02-2025
- Health
- The Hill
HHS postpones meeting of key CDC vaccine panel, one week after RFK Jr. sworn in
The first meeting of a Centers for Disease Control and Prevention (CDC) vaccine advisory committee since Robert F. Kennedy Jr. was sworn in as Health and Human Services (HHS) secretary has been postponed, the department confirmed. The Advisory Committee on Immunization Practices (ACIP) was set to meet from Feb. 26 to 28 and discuss and vote on multiple vaccine issues, including recommendations for the use of a meningitis vaccine in infants and new recommendations on influenza and RSV vaccines. There was no timeframe given for when the meeting would be rescheduled. 'The ACIP meeting will be postponed to accommodate public comment in advance of the meeting,' HHS spokesman Andrew Nixon said in an email. 'The ACIP workgroups met as scheduled this month and will present at the upcoming ACIP meeting.' The ACIP convenes three times a year to advise the CDC on vaccine issues, but the agency doesn't have to follow the recommendations. However, if the CDC director signs off on the panel's recommendations, ACIP-recommended vaccines must be covered by health insurance. ACIP members aren't government employees. The panel includes up to 18 voting members representing clinical medical fields as well as public health professionals, as well as at least one consumer representative. Members of the public can submit comments online through an official portal for two weeks ahead of the meeting, as well as register for a lottery to make comments live during the meeting. But the online portal was never activated, leaving the public unable to submit comments. The postponement comes amid growing fears about the panel's future under an HHS led by Kennedy, one of the country's most prominent anti-vaccine activists. Kennedy and his allies have long alleged ACIP members are corrupting HHS's research priorities through conflicts of interest, and during his confirmation hearing pledged to root out conflicts of interest. An executive order issued by President Trump on Wednesday also targets federal advisory committees for review and possible termination 'on [the] grounds that they are unnecessary,' including ACIP. As of early Thursday afternoon, ACIP members were not notified of any changes to the meeting schedule, according to Dr. H. Keipp Talbot, the panel's chair. The Partnership to Fight Infectious Disease and 50 medical organizations and experts, including the American Medical Association, sent a letter to Kennedy and acting CDC Director Susan Monarez urging them to reschedule the meeting as soon as possible. 'Making America healthy requires healthy discussion and timely, evidence-based decisions. This meeting should be no different,' they wrote. 'Rescheduling this critical meeting … would represent a meaningful early follow-through from the Trump administration and its new HHS Secretary to ensure Americans receive the information needed to protect themselves against vaccine-preventable illnesses, confirming immunization's importance in the mission to make America healthier.'
