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Global HIV/AIDS effort in rescissions crosshairs
Global HIV/AIDS effort in rescissions crosshairs

Axios

time6 days ago

  • Health
  • Axios

Global HIV/AIDS effort in rescissions crosshairs

The rescissions package the White House sent Congress on Tuesday calls for deleting $900 million for global health programs — including PEPFAR, which is causing heartburn for some Republicans. Why it matters: Public health experts warn that the cuts would restrict access to lifesaving treatments and hinder U.S. soft diplomacy. The State Department–run HIV/AIDS program is still operating even though it hasn't been officially reauthorized, but it's limited and doesn't cover many HIV prevention efforts. What's inside: The $9.4 billion rescissions package identified $900 million in DOGE-directed cuts to State Department and USAID global health programs for Congress to codify. The document OMB sent to the Hill calls for eliminating $500 million for USAID programs related to child and maternal health, HIV/AIDS and infectious diseases. It states that the proposal "would not reduce treatment but would eliminate programs that are antithetical to American interests and worsen the lives of women and children, like 'family planning' and 'reproductive health.'" An additional $400 million would be rescinded for controlling HIV/AIDS, which includes PEPFAR. What they're saying: Senate Appropriations Chair Susan Collins told reporters Tuesday that she wouldn't support a package that cuts PEPFAR. The program "has saved literally millions of lives and has been extremely effective and well-run," Collins said. She referred to it as a legacy program of former President George W. Bush. But House Foreign Affairs Chair Brian Mast told Axios on Tuesday that there was "a lot of pretty specific waste within PEPFAR" and that this rescissions package would make it "a better program." House Appropriations Chair Tom Cole also said that although he was "worried about PEPFAR," he was going to support the rescissions package, adding, "I think most of our members will.… I don't think it will have a hard time passing."

DOGE cuts cause FDA to delay decision on hereditary disease drug
DOGE cuts cause FDA to delay decision on hereditary disease drug

Axios

time16-06-2025

  • Business
  • Axios

DOGE cuts cause FDA to delay decision on hereditary disease drug

The Food and Drug Administration will miss a deadline this week deciding whether to approve a drug for a potentially life-threatening disorder because of "heavy workload and limited resources," manufacturer KalVista Pharmaceuticals said. Why it matters: It appears to be the first time an FDA review had to be extended because of DOGE-directed cuts to staff at the agency. The big picture: Health industries pay billions developing and shepherding drugs, devices and tests through the regulatory process, including user fees that help ensure there's enough staff to evaluate products on a predictable timeline. Drug companies previously expressed concerns that the timeframes for these sorts of decisions would begin slipping because of staff and budget cuts. KalVista said the FDA notified the company it would miss its decision date of June 17 for a new drug application for the oral drug, called sebetralstat, that targets hereditary angioedema. The condition is a rare genetic disorder in which patients can experience experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening. The agency did not request any additional data or studies or raise concerns about the drug, the company said. It indicated it expects to deliver a decision within approximately four weeks, the company said. What they're saying:"One delay does not a trend make," wrote Chris Meekins, a Raymond James analyst and health official in the first Trump administration.

Trump fires three consumer watchdog commissioners as he dismantles agency
Trump fires three consumer watchdog commissioners as he dismantles agency

Yahoo

time09-05-2025

  • Business
  • Yahoo

Trump fires three consumer watchdog commissioners as he dismantles agency

The Trump administration is breaking up the Consumer Product Safety Commission, a small but powerful independent watchdog that for five decades has quietly kept dangerous toys, cribs, and electronics out of American homes. The administration on Thursday night fired three Biden-appointed commissioners on the five-member CPSC board — Alexander Hoehn-Saric, Mary T. Boyle, and Richard Trumka Jr. — just hours after two staffers with the Department of Government Efficiency were scheduled to meet with acting Chairman Peter Feldman at the agency's Bethesda headquarters, according to two people familiar with the meeting granted anonymity to avoid retribution. Hoehn-Saric said that while he has received no direct communication from the White House, Feldman has barred him from performing his duties. The three fired commissioners voted to block an attempt by Feldman to officially bring on the pair from DOGE, Trumka Jr. said in a statement. 'Rather than respect the democratic process, soon after, I received the email purporting to fire me,' Trumka, son of the late labor leader Richard Trumka, said, vowing to sue over his removal. By midmorning their names were already gone from their office doors, according to a current staffer granted anonymity out of fear of retribution. The firings come on the heels of the commissioners' opposition to any DOGE-directed layoffs and the reclassification of more than 70 CPSC employees, including safety engineers, hazard analysts, and outreach staff responsible for educating manufacturers and consumers. Boyle, Hoehn-Saric, and Trumka argued that the agency was already operating below its appropriated staffing levels and that cuts would undercut critical safety work. 'These terminations will inevitably result in emergency room visits or deaths that could and should have been avoided,' warned Hoehn-Saric, who was appointed in 2021 and confirmed unanimously by the Senate. The Trump administration is pushing forward with a plan to eliminate the CPSC as an independent agency and absorb its work into the Department of Health and Human Services, according to a proposed budget document obtained by POLITICO. The draft budget creates a new office within HHS, headed by an 'Assistant Secretary for Consumer Product Safety,' that would 'absorb functions and staff from the [CPSC]' and carry on the commission's core mission of protecting Americans from unreasonable risks of injury or death from consumer products. The new division would have a proposed annual budget of $135 million, around ten percent less than its current funding level of $151 million. The plan would require sign off from congressional appropriators and may face a series of other legal challenges as the commission was created by statute. The firings and the broader restructuring have sparked a firestorm from the commissioners, who argue the administration is illegally gutting a life-saving agency. 'CPSC was created to be independent of the White House precisely so that decisions about public safety would not be subjected to political whims,' Hoehn-Saric said Boyle, who has spent 15 years at the CPSC as a lawyer and senior official, called her termination an act of retaliation for refusing to 'be complicit with the efforts of DOGE to destroy the agency.' 'DOGE shows no respect for expertise, no respect for public servants, no respect for the citizens our government serves,' she said in a statement. 'Random layoffs with no rationale don't reform government; they disable it.' White House Press Secretary Karoline Leavitt pushed back, telling POLITICO: 'Is the federal agency within the executive branch? Who is the head of the executive branch? He has the right to fire people within the executive branch.' According to both Boyle and Hoehn-Saric, the firing came just days after the Democratic commissioners voted to advance a proposed safety standard on lithium-ion batteries, which have been linked to more than 20 deadly fires involving e-bikes and e-scooters. The vote directly defied a Trump-era executive order requiring White House review of all regulatory proposals — a directive the commissioners say violates their statutory independence. 'We advanced the rule to gather public input, not implement it,' said Boyle. 'That's the process we've followed for decades. This administration wants to bury it behind closed doors.' Created in the 1970s, the CPSC has long operated as a low-profile but powerful agency that issues recalls, enforces safety standards and litigates against companies selling unsafe products. Such actions can be a deathblow for companies, and the agency has faced legal challenges over the years from businesses like Amazon and conservative legal groups in an effort to reel it in. Last fall the Supreme Court turned away a petition that sought to undermine the CPSC by arguing that its insulation from the president violated the separation-of-powers clause.

Trump fires three consumer watchdog commissions as he dismantles agency
Trump fires three consumer watchdog commissions as he dismantles agency

Politico

time09-05-2025

  • Business
  • Politico

Trump fires three consumer watchdog commissions as he dismantles agency

The Trump administration is breaking up the Consumer Product Safety Commission, a small but powerful independent watchdog that for five decades has quietly kept dangerous toys, cribs, and electronics out of American homes. The administration on Thursday night fired three Biden-appointed commissioners on the five-member CPSC board — Alexander Hoehn-Saric, Mary T. Boyle, and Richard Trumka Jr. — just hours after two staffers with the Department of Government Efficiency were scheduled to meet with acting Chairman Peter Feldman at the agency's Bethesda headquarters, according to two people familiar with the meeting granted anonymity to avoid retribution. Hoehn-Saric said that while he has received no direct communication from the White House, Feldman has barred him from performing his duties. The three fired commissioners voted to block an attempt by Feldman to officially bring on the pair from DOGE, Trumka Jr. said in a statement. 'Rather than respect the democratic process, soon after, I received the email purporting to fire me,' Trumka, son of the late labor leader Richard Trumka, said, vowing to sue over his removal. By midmorning their names were already gone from their office doors, according to a current staffer granted anonymity out of fear of retribution. The firings come on the heels of the commissioners' opposition to any DOGE-directed layoffs and the reclassification of more than 70 CPSC employees, including safety engineers, hazard analysts, and outreach staff responsible for educating manufacturers and consumers. Boyle, Hoehn-Saric, and Trumka argued that the agency was already operating below its appropriated staffing levels and that cuts would undercut critical safety work. 'These terminations will inevitably result in emergency room visits or deaths that could and should have been avoided,' warned Hoehn-Saric, who was appointed in 2021 and confirmed unanimously by the Senate. The Trump administration is pushing forward with a plan to eliminate the CPSC as an independent agency and absorb its work into the Department of Health and Human Services, according to a proposed budget document obtained by POLITICO. The draft budget creates a new office within HHS, headed by an 'Assistant Secretary for Consumer Product Safety,' that would 'absorb functions and staff from the [CPSC]' and carry on the commission's core mission of protecting Americans from unreasonable risks of injury or death from consumer products. The new division would have a proposed annual budget of $135 million, around ten percent less than its current funding level of $151 million. The plan would require sign off from congressional appropriators and may face a series of other legal challenges as the commission was created by statute. The firings and the broader restructuring have sparked a firestorm from the commissioners, who argue the administration is illegally gutting a life-saving agency. 'CPSC was created to be independent of the White House precisely so that decisions about public safety would not be subjected to political whims,' Hoehn-Saric said Boyle, who has spent 15 years at the CPSC as a lawyer and senior official, called her termination an act of retaliation for refusing to 'be complicit with the efforts of DOGE to destroy the agency.' 'DOGE shows no respect for expertise, no respect for public servants, no respect for the citizens our government serves,' she said in a statement. 'Random layoffs with no rationale don't reform government; they disable it.' White House Press Secretary Karoline Leavitt pushed back, telling POLITICO: 'Is the federal agency within the executive branch? Who is the head of the executive branch? He has the right to fire people within the executive branch.' According to both Boyle and Hoehn-Saric, the firing came just days after the Democratic commissioners voted to advance a proposed safety standard on lithium-ion batteries, which have been linked to more than 20 deadly fires involving e-bikes and e-scooters. The vote directly defied a Trump-era executive order requiring White House review of all regulatory proposals — a directive the commissioners say violates their statutory independence. 'We advanced the rule to gather public input, not implement it,' said Boyle. 'That's the process we've followed for decades. This administration wants to bury it behind closed doors.' Created in the 1970s, the CPSC has long operated as a low-profile but powerful agency that issues recalls, enforces safety standards and litigates against companies selling unsafe products. Such actions can be a deathblow for companies, and the agency has faced legal challenges over the years from businesses like Amazon and conservative legal groups in an effort to reel it in. Last fall the Supreme Court turned away a petition that sought to undermine the CPSC by arguing that its insulation from the president violated the separation-of-powers clause.

FDA rebuilds its AI staff
FDA rebuilds its AI staff

Politico

time08-05-2025

  • Health
  • Politico

FDA rebuilds its AI staff

THE REGULATORS The FDA is gathering up AI talent. The Food and Drug Administration is bringing on new artificial intelligence talent and wooing back tech talent it cut during its DOGE-directed reduction in force in April. On Thursday, the agency said it would roll out generative AI agency-wide by June 30. Sridhar Mantha, former director of the FDA's Office of Strategic Policy within the Center for Drug Evaluation and Research, has returned, according to two people with knowledge of the move who were granted anonymity to speak about sensitive personnel matters. Mantha, who co-chaired CDER's AI Council, has been integral to the division's IT and AI projects. He's now working in the Office of the Commissioner. Meanwhile, FDA Commissioner Marty Makary has brought on Jeremy Walsh to head up AI and IT at the agency. Walsh announced the move last Friday on LinkedIn. He comes from the government contractor Booz Allen Hamilton, where he worked for 14 years and was chief technologist, building out cloud networks and data analytics systems for the agencies the firm works with. While at Booz Allen, Walsh worked on contracts with the FDA, the Centers for Disease Control and Prevention, the National Institutes of Health, the Department of Veterans Affairs and military health services. Why it matters: After firing thousands of employees, Health Secretary Robert F. Kennedy Jr. has had to rehire staff who were essential to operations. That includes medical device review staff, tobacco enforcement agents and, reportedly, staff who booked travel for safety inspectors. What's next: AI is poised to play a large role in the Department of Health and Human Services. Kennedy, Makary and Centers for Medicare and Medicaid Services Administrator. Dr. Mehmet Oz have spoken about how they see big opportunities to make health care better and cheaper with AI. It's not clear yet how that will extend into government operations. WELCOME TO FUTURE PULSE This is where we explore the ideas and innovators shaping health care. Nicole Shanahan, Health Secretary Robert F. Kennedy Jr.'s former running mate, isn't happy about the Trump administration's pick for surgeon general, Casey Means. 'Doesn't make any sense. I was promised that if I supported RFK Jr. in his Senate confirmation that neither of these siblings would be working under HHS or in an appointment (and that people much more qualified would be),' she wrote on X. Trump booster and far-right activist Laura Loomer was equally unimpressed with Means' appointment. Share any thoughts, news, tips and feedback with Danny Nguyen at dnguyen@ Carmen Paun at cpaun@ Ruth Reader at rreader@ or Erin Schumaker at eschumaker@ Want to share a tip securely? Message us on Signal: Dannyn516.70, CarmenP.82, RuthReader.02 or ErinSchumaker.01. SMALL BYTES The federal office charged with regulating health care IT is toning down enforcement of its health IT certification program in line with President Donald Trump's executive order that called for deregulation. Typically, developers for certified EHR platforms need to report details about their systems, like usage statistics, data-sharing issues, supported applications and vaccination records to the Assistant Secretary for Technology Policy/Office of the National Coordinator. That office oversees the Department of Health and Human Services's data, technology and AI strategies. But the office now will only expect health IT developers to report on their platform's use of FHIR, a public standard for sending and receiving data. 'They're deregulating, but they're saying FHIR [application programming interfaces'] are important,' said Brendan Keeler, interoperability practice lead of HTD Health, a health technology consultancy. The changes will take effect on July 1, 2027. BUSINESS PLAN Meta expands its App Store regulation campaign to Europe. Meta-owned Instagram rolled out a campaign on Tuesday to ask for EU regulation that would require age verification to happen at the App Store level and not by the apps themselves. The campaign will run in Belgium, Denmark, France and Italy until the end of June, a Meta spokesperson told POLITICO Europe's Morning Tech. Everyone in the EU agrees that someone needs to implement age verification but the app stores and apps are trying to shift the responsibility onto each other. The Commission is fairly late in releasing guidelines to protect minors that could put an end to this controversy by outlining who should do it — or require that both services have some responsibility and age verification could happen in layers. Why it matters: This push to make app stores the party responsible for ensuring underage users don't have untoward experiences on their phones extends from a campaign Meta is running in the U.S. A Utah law — the first in the country — that holds app stores accountable for ensuring parents sign off on the apps minors download took effect this week. Republicans in Congress have introduced twin bills that would require app stores to implement age verification. Meta, as well as Snap and X are supporting them.

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