Latest news with #FederalAdvisoryCommitteeAct
TimesLIVE
4 days ago
- Politics
- TimesLIVE
Groups sue Trump agencies for using 'secret' report to reverse core of US climate rules
Two major environmental groups announced on Tuesday they have sued the Trump administration for secretly convening a group of climate sceptics, which prepared a report that served as the basis for a reversal of US rules on greenhouse gas emissions without public notice. The Environmental Defence Fund and the Union of Concerned Scientists filed the lawsuit in a federal-district court in Massachusetts, arguing that the so-called Climate Working Group that energy secretary Chris Wright put together, evaded public view, delivered erroneous results and was illegally used to inform the Environmental Protection Agency's decision to reverse the scientific finding that served as the foundation for federal climate regulation. The lawsuit names Wright and Environmental Protection Agency Administrator Lee Zeldin as defendants. Both were not immediately available for comment. WHY IS THIS IMPORTANT? The preparation and use of the report has raised concern that the US is rejecting the mainstream consensus about the causes and impacts of climate change at a time when more severe storms and record-breaking temperatures cause trillions of dollars in damage around the country. Downplaying the impacts of climate change and eliminating US climate data collection and reports also takes away the urgency for the US to shift away from fossil fuels towards cleaner energy. KEY CONTEXT Through the Federal Advisory Committee Act, Congress requires public disclosure and public records in the establishment and operation of any federal advisory committee. KEY QUOTE 'Decades of rigorous scientific analysis shows burning fossil fuels is unequivocally contributing to deadly heatwaves, accelerating sea level rise, worsening wildfires and floods, increased heavy rainfall, and more intense and damaging storms across the country. We should all relentlessly question who stands to gain from efforts to upend this unassailable and peer-reviewed scientific truth,' said Gretchen Goldman, president of UCS.
Politico
11-07-2025
- Business
- Politico
FDA funding clash looms between Senate, House
With Ruth Reader Driving the Day MONEY ON MY MIND — Despite the Trump administration's efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill Thursday that maintains the agency's funding in fiscal 2026 at roughly the same level as in fiscal 2025. The Senate Appropriations Committee bill, which advanced by a 27-0 vote, funds the agency at $7 billion, comprised of $3.6 billion in taxpayer funds and $3.4 billion in user fee revenues. Funding wars: That sets up a showdown with the House, which advanced a party-line FDA spending bill out of committee last month that funds the agency with $6.8 billion in total funding, in line with what President Donald Trump asked Congress to provide to the agency. Both measures are set for floor action, but there is still no broader funding agreement in place to keep federal agencies running beyond the Sept. 30 government shutdown deadline. Congress could resort to a stopgap funding patch in the fall. Senate report language: A handful of nuggets are buried in the Senate's committee report — including an admonishment of FDA Commissioner Marty Makary for convening panels on talc, infant formula and cell and gene therapies. 'The FDA should assess scientific issues in a transparent manner and must adhere to principles established by Congress in the Federal Advisory Committee Act,' the report states. 'The Committee is concerned that the agency did not allow public participation or provide for public comments and panelists did not disclose potential conflicts of interest.' HHS spokesperson Andrew Nixon questioned the report's language, describing it as a 'misleading political attack that ignores basic facts.' 'The idea from Congress that it is not acceptable for the FDA Commissioner to meet directly with stakeholders goes against the founding principle of our nation — free speech,' Nixon said in a text. 'Dr. Makary's roundtables with stakeholders were transparent, science-driven, and entirely appropriate — engaging directly with them instead of relying on panels packed with industry interests. That's what the public deserves.' Staffing challenges: Lawmakers on the panel also raised concerns about 'hiring restrictions in place at the FDA for scientists, product reviewers and inspectors.' 'The Committee is aware of the challenges facing recruitment and retention of qualified candidates for these positions and directs the FDA to remove the hiring restrictions in place for these key roles within 30 days of enactment of this act,' the report states. Nixon pushed back on the assertion, saying the agency is already able to hire the scientists, inspectors and product reviewers it needs due to exemptions in place. 'We support efforts to modernize and strengthen the agency's workforce, and agree that top-tier scientific talent is essential to keeping pace with innovation and protecting public health,' he said. IT'S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. For fellow dog lovers out there: The FDA approved the first long-acting flea and tick preventive drug for dogs yesterday. Send 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 YOU'VE (ALREADY) GOT MAIL — The FDA on Thursday made available for download more than 200 rejection letters issued for product applications, part of a bid to foster more transparency around the agency's work process. Notably, the released letters are associated with submissions that have since been approved, and many had already been publicly released. They've been redacted for confidential commercial information and trade secrets. HHS spokesperson Andrew Nixon acknowledged some of the letters had already been disclosed as part of product approval packages. But that system, he said, meant the letters were 'scattered and hard to find.' 'Now, we are centralizing it,' Nixon said. Marc Scheineson, a former FDA official, called the idea to release more complete response letters 'fraught with difficulties and complexity' that would likely draw industry opposition or lawsuits if preliminary letters were made public instead of following a product approval. 'The proposal shows that most of the adult experienced senior agency leadership has been depleted or disregarded (since similar issues have been scrutinized previously),' Scheineson wrote in an email. 'Publicizing the often unvetted, and occasionally incorrect, view of the FDA (if negative) without balance can cause a sponsor's stock to drop dramatically overnight.' The biotech industry has questions about the practice moving forward. 'The industry is supportive of increased transparency and clarity in communications throughout the FDA review process,' a Biotechnology Innovation Organization spokesperson said. 'The specifics — including management and timing of the release of material information for sponsors will be important.' FDA Commissioner Marty Makary touted the document dump, which covered decisions made between 2020 and 2024, as a way to give the public more information about the kinds of deficiencies the agency typically finds before a drug or biologic is ultimately approved. 'Drug developers and capital markets alike want predictability,' he said in a statement. 'So today we're one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.' FDA OKs MODERNA KID VAX — The FDA approved Moderna's Covid-19 vaccine for children under 12 who are at high risk for the disease, the company said Thursday. The narrow label hews to FDA Commissioner Marty Makary's Covid vaccine framework, which prioritizes approving future formula updates for people 65 and older and for younger individuals with underlying conditions that could contribute to severe disease. The FDA has recommended that vaccine makers conduct randomized controlled trials for Covid shots' use in healthy people now that most Americans have acquired immunity from past vaccination, infection or both. Industry Intel PALANTIR EYES FDA — The co-founder of government contracting giant Palantir wrote this week that he wants to deploy artificial intelligence specialists into the FDA to help the agency expedite initiatives using the controversial technology, Ruth writes. Joe Lonsdale — a Peter Thiel mentee and GOP donor — wrote on Substack that he wants to embed a team of 15 to 20 'elite engineers' inside the agency, which recently deployed an AI chatbot touted as a tool to help staff accelerate medical product reviews. He's working with two organizations, the Abundance Institute, a year-old Utah-based nonprofit that hopes to accelerate the adoption of artificial intelligence, and Stand Together, a philanthropic organization founded by billionaire Charles Koch, to raise $4 million and train fellows who would be deployed at federal agencies. How exactly can billionaires just drop a team of engineers and product managers into a government agency? Through the Intergovernmental Personnel Act, a 1970 law that allows the government to forgo typical hiring practices to bring on experts from academia and nonprofits; those fellows 'can sit desk‑to‑desk with reviewers,' according to Lonsdale. But HHS spokesperson Andrew Nixon said the agency has no plans to take on fellows from Abundance Institute and Stand Together. Christopher Koopman, CEO of the Abundance Institute, told Ruth his organization has had discussions about bringing on its fellows with the FDA. And he said that — based on discussions with former FDA officials — he's under the impression that slow review times are a technical problem. 'They're problems of capability, not authority. That's what sparked the idea: What if we could forward-deploy [AI engineers] … to help build modern systems and workflows that empower the FDA to do what it's already allowed to do, only better and faster?' he said. Even so: FDA staff granted anonymity had previously told POLITICO that the agency's chatbot likely doesn't have the ability to reduce review times. The challenges at the agency, they said, are more complicated than simply hiring more tech talent. Pharma Moves Cancer therapy company Iovance Biotherapeutics has named Dr. Marc Theoret as senior vice president for regulatory strategy. He previously worked at the FDA, holding roles within the agency's Oncology Center of Excellence and Center for Drug Evaluation and Research. Carrie Swope is director of federal advocacy at the American Academy of Pediatrics. She previously was a policy staffer on Capitol Hill, most recently serving as a policy director for the Senate Special Committee on Aging. Document Drawer The FDA is holding an interim public meeting on the BsUFA III Regulatory Science Pilot Program on Sept. 18. WHAT WE'RE READING House Oversight Committee Democrats are asking for a CDC staff briefing over the changes to the agency's Advisory Committee on Immunization Practices, Inside Health Policy's Jessica Karins reports. South Africans are worried HIV infections may spike after cuts in U.S. aid, the BBC's Mayeni Jones reports.
Time of India
25-06-2025
- Health
- Time of India
What is the role of Kennedy's newly appointed US vaccine advisory panel?
U.S. Health Secretary Robert F. Kennedy Jr. fired all 17 members of a national vaccine advisory board, naming eight new members of his choosing and upending the process for recommending shots for the American public. The surprise move drew widespread condemnation from doctors and public health experts, who say it will further undermine confidence in national vaccine policy. Here are details on how the panel works: by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like If You Eat Ginger Everyday for 1 Month This is What Happens Tips and Tricks Undo WHAT IS THE PANEL'S ROLE? The Advisory Committee for Immunization Practices, or ACIP, is an outside panel of experts that helps the U.S. Centers for Disease Control and Prevention decide how specific vaccines are used, who should be taking them, and when they should do so. The committee makes recommendations to the CDC on vaccines that have already been approved as safe and effective by the U.S. Food and Drug Administration. Live Events ACIP members vote on recommendations for a vaccine's use in a public meeting, after reviewing data on how specific diseases affect different populations, information on vaccine safety and efficacy, economic analyses and implementation issues. Their recommendations are not binding and can be overruled by the CDC director, a rare but not unprecedented occurrence. Once the CDC director signs off on the ACIP recommendations, they become part of the U.S. vaccine schedule for adults and children, which is used to determine health insurance coverage. The Affordable Care Act generally requires insurers to cover vaccines that are listed on the CDC vaccine schedule. The recommendations also determine what the CDC's Vaccines for Children program will provide free of charge to families without insurance. HOW ARE ITS MEMBERS APPOINTED? Up to 19 voting ACIP members are appointed to four-year terms by the U.S. Secretary for Health and Human Services, according to the panel's charter. It has six non-voting members representing the Health Resources and Services Administration; the FDA; the Centers for Medicare and Medicaid Services; the National Institutes of Health; the Indian Health Service; and HHS's Office of Infectious Disease and HIV/AIDS Policy. There are an additional 31 non-voting liaisons from various medical associations, industry groups and other organizations. All 17 members fired by Kennedy had been appointed by President Joe Biden, including 13 who began their terms in 2024. Kennedy does have authority under the Federal Advisory Committee Act to add and remove members. Firings of advisory committee members are rare, however. The law also requires a diversity of viewpoints across the membership. Vetting and onboarding new panel members typically takes months to ensure they are qualified and free of conflicts of interest. HOW DOES IT MANAGE CONFLICTS OF INTEREST? Kennedy justified the firings by saying the departing ACIP panel was rife with conflicts of interest but provided no specific evidence for individual advisers. ACIP members must declare any potential conflicts of interest that arise in the course of their tenure and any relevant business interests, positions of authority or other connections with organizations relevant to the committee's work. Members must abstain from votes on any vaccine for which they have a conflict, as well as any rival to that vaccine or any product from the same manufacturer, according to CDC rules. They are required to divest all stock in vaccine makers and stop any active consulting work for those companies before joining the panel. They cannot accept travel or food from vaccine companies or collect product royalties. Similar restrictions apply to family members. ACIP members can keep working on vaccine clinical trials funded by industry and those research grants can help cover their salaries. They are required to file annual disclosures and recuse themselves from votes when specific conflicts arise. CAN THE FIRINGS BE CHALLENGED? The American Medical Association, the influential trade group for physicians, urged the U.S. Senate Committee that confirmed Kennedy as health secretary to investigate the ACIP shakeup, saying it undermines public trust in vaccines. Kennedy's ouster of ACIP members could also end up in court, said Professor Sara Rosenbaum, chair of the Department of Health Policy at the George Washington University School of Public Health and a former ACIP adviser. Health insurers, drugmakers and providers who all use the committee's recommendations could have grounds to mount legal challenges, she said. The lawsuits could be brought under the Administrative Procedure Act, which directs how federal agencies make changes such as appointments and removals. Courts have ruled against this type of change to advisory committee membership in other cases. During President Donald Trump's first administration, at least three courts sided with the challengers in a group of lawsuits over a directive that resulted in the disqualification of many scientists serving on Environmental Protection Agency advisory committees.
Yahoo
05-03-2025
- Business
- Yahoo
Trump said in his address that Musk runs DOGE — a comment that immediately landed in an ongoing court battle
Donald Trump continues to call Elon Musk DOGE's leader. Trump's latest comments came during his joint address to Congress. The White House and the Justice Department have said Musk is not leading DOGE. During his record-setting joint address to Congress, President Donald Trump continued calling Elon Musk the leader of the White House DOGE office. "I have created the brand-new Department of Government Efficiency, DOGE, perhaps you've heard of it, which is headed by Elon Musk, who is in the gallery tonight," Trump said in his speech Tuesday night. Trump's habit of saying Musk is in charge of the group is already creating legal headaches for his administration, which has repeatedly said the Tesla CEO is not actually leading DOGE. A group of plaintiffs challenging DOGE's constitutionality immediately alerted a Washington, DC, federal judge to Trump's comments almost as soon as the president finished his speech. "At approximately 9:46 PM, President Trump stated the following in his Joint Address to Congress," the plaintiffs wrote in their filing. The plaintiffs, who include two attorneys, quickly filed a lawsuit against the Trump administration on the day Trump was sworn into office, arguing that the creation of DOGE violates the transparency requirements of the 1972 Federal Advisory Committee Act. The lawsuit declares DOGE a federal advisory committee that should be subject to the FACA law. The law, which was designed to boost public accountability, covers advisory committees that are either formed or utilized by the president. An amended lawsuit filed by the plaintiffs says "Musk continues to speak for DOGE and take credit for DOGE's activities, while not being" the administrator for the US DOGE Service. DOGE was birthed out of a rebrand of the United States Digital Service — a technology unit housed in the executive office of the president. "DOGE continues to take actions which are completely unrelated to the USDS mandate set forth" in Trump's day one executive order that formally established DOGE, the amended complaint says. US District Judge Jia Cobb has since consolidated the case with two other similar cases. Meanwhile, a top White House official previously declared in federal court that Musk was neither the DOGE office administrator nor even an employee of the group. The White House has also repeatedly stressed that Musk is just a senior advisor to the president. After weeks of refusing to name DOGE's administrator publicly, the White House said that Amy Gleason, a US Digital Service employee, was the acting administrator of the DOGE office. Multiple signs suggest that Musk remains DOGE's de facto leader, dating back to Trump's initial creation of "The Department of Government Efficiency," when he named the billionaire as its co-leader. Just days ago, a DOJ lawyer struggled to answer questions about DOGE's structure. "Who was the head of DOGE before Amy Gleason," the judge asked, according to Lawfare's Anna Bower. The DOJ counsel responded, "I can't answer that. I don't know." Trump is no stranger to making public statements that create headaches for the Justice Department. During his first term, Trump's tweets were repeatedly used as evidence in various lawsuits brought against his administration. At one point, the DOJ said that Trump's tweets were not presidential actions. The White House didn't immediately return a request for comment by Business Insider. Read the original article on Business Insider
Yahoo
05-03-2025
- Business
- Yahoo
Lawyers in DOGE challenge use Trump remarks before Congress in new filing
President Trump's address to Congress on Tuesday night has already made its way into court, with a group of plaintiffs seeking to dismantle the Department of Government Efficiency (DOGE) quickly latching onto the remarks. 'DOGE — perhaps you've heard of it. Perhaps,' Trump said during his address. 'Which is headed by Elon Musk, who is in the gallery tonight.' In court, the administration has repeatedly insisted Musk is not a formal part of DOGE and that he is a senior adviser in the White House with no actual authority. The administration has instead named Amy Gleason as interim DOGE administrator. Kelly McClanahan, an attorney representing plaintiffs in a lawsuit claiming DOGE's setup doesn't comply with federal law, submitted a new court filing alerting the judge to Trump's remarks minutes after his speech concluded. Calling it 'new evidence,' McClanahan asked the judge to keep Trump's speech in mind as she weighs a request that Musk and other officials sit for depositions in the case. The attorney wrote that the president's speech 'conclusively demonstrates that expedited discovery is urgently needed to ascertain the nature of the Department of Government Efficiency.' DOGE faces more than two dozen lawsuits that challenge the group's rapid efforts to implant itself across the federal bureaucracy and cut spending, agency by agency. Musk's role has become a central component of many of the cases. McClanahan represents two individual attorneys who are suing over claims that DOGE is subject to the Federal Advisory Committee Act, which mandates various transparency requirements for advisory committees. U.S. District Judge Jia Cobb, an appointee of former President Biden who oversees the case, is set to soon rule on the plaintiffs' request that Musk sit for a deposition. It would add to another judge's ruling, issued last week, ordering certain officials involved in DOGE to sit for depositions as part of a separate lawsuit. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
