Pediatricians face off against the government
The American Academy of Pediatrics, the nation’s leading professional organization for doctors who care for kids, and the nation’s federal health agency, the Department of Health and Human Services, are at odds.
Both groups are dedicated to combating chronic diseases in children, but their approaches are diverging. AAP has taken on new roles in the second Trump administration, challenging vaccine policy changes and positioning itself as the primary source for vaccine advice in the absence of government guidance. Today, they are seeking a federal judge’s intervention to overturn Kennedy’s recent reforms.
How is AAP adapting its public stance and internal structures to navigate this political landscape? STAT’s Daniel Payne provides insights into the evolving dynamics.
The fallout from the FDA’s rejection of the Moderna vaccine
Will the FDA’s decision hinder vaccine development in the U.S.? The FDA’s refusal to review Moderna’s flu vaccine has raised concerns that companies might be discouraged from investing in new vaccines, potentially leaving the country vulnerable to future pandemics.
Executives at major vaccine companies are facing uncertainty following Health Secretary Robert F. Kennedy Jr.’s actions, which include removing vaccines from the childhood vaccination schedule and replacing members of an important immunization advisory board.
A letter sent to Moderna by a senior FDA official, Vinay Prasad, has generated apprehension within the industry, possibly prompting companies to explore vaccine development opportunities abroad. This setback adds to a series of challenges faced by Moderna. Learn more from STAT’s Jason Mast.
For Moderna’s perspective on these developments, tune in to an interview between Moderna President Stephen Hoge and STAT’s “The Readout LOUD” podcast.
HHS announces changes in key advisers
Four political appointees at HHS have been promoted to higher positions, as part of the department’s efforts to advance Health Secretary Robert F. Kennedy Jr.’s Make America Healthy Again agenda.
Chris Klomp, a former health IT CEO, will now serve as the chief counselor at HHS, overseeing all department operations. Klomp previously led the Centers for Medicare and played a significant role in the department’s initiatives to lower drug prices. He recently joined a delegation of HHS officials, including Centers for Medicare and Medicaid Administrator Mehmet Oz, in discussions with key Senate Republicans on drug pricing legislation.
Kyle Diamantas and Grace Graham have been appointed as senior counselors for the Food and Drug Administration. Graham previously served as the FDA’s deputy commissioner for policy. Diamantas, an attorney associated with Donald Trump Jr., held the position of deputy commissioner for human foods. John Brooks will also serve as a senior counselor at CMS, having previously been CMS’s chief policy and regulatory officer before transitioning into health policy consulting. – Chelsea Cirruzzo
New labeling for menopause products approved
The FDA has granted approval for new labels on six menopause hormone therapies, following the agency’s decision to remove a longstanding requirement for these products to carry a black box warning label highlighting cardiovascular, dementia, and breast cancer risks. Nearly 30 companies submitted proposed label changes at the FDA’s request, with the initial approvals covering both systemic and vaginal products.
Reactions to the label changes have been mixed, given the unconventional process leading to the decision and the broad application of the changes to both vaginal and systemic products, each associated with varying levels of risk. FDA Commissioner Marty Makary’s references to divorce and death as consequences of untreated symptoms have also raised eyebrows. For more insights into the decision-making process and the information retained on the labels, refer to our previous report. Additionally, explore the evidence supporting these products in a 2024 article. – Theresa Gaffney
Department of Labor settles on ghost networks
The Department of Labor has reached a $28 million settlement with the Kaiser Foundation Health Plan to address multiple investigations into the company’s failure to provide access to mental health and substance use disorder care.
This resolution follows years of legal battles against insurance companies for inaccuracies in provider lists, leading to the creation of “ghost networks.” Studies have shown that patients were unable to schedule appointments with over 80% of providers listed as in-network, forcing them to seek care outside their network at higher costs.
The settlement impacts millions of Kaiser insurance beneficiaries in California, introducing a claims process for members to seek reimbursement for certain out-of-network expenses. Read the full statement for more details.
Emergence of new disease surveillance systems amid U.S. global health retreat
Amid decreasing global health funding, particularly from the United States, other organizations are stepping up efforts to prepare for potential infectious disease threats. The Coalition for Epidemic Preparedness Innovations is launching a new five-year strategy, aiming to raise $2.5 billion to bolster global disease surveillance and expedite vaccine development against new pandemic threats within 100 days.
Addressing the challenge of the delayed response to Covid-19, initiatives like this seek to enhance global readiness for future health crises. Meanwhile, concerns have been raised about the CDC’s discontinued surveillance databases, including crucial vaccination-related systems. Proposals for new surveillance networks utilizing state-level consortiums and medical centers, integrating electronic health records from providers like Epic, are being advocated to prevent gaps in disease monitoring. – Helen Branswell
For more in-depth analysis on these topics, refer to the original article on STAT and explore additional resources to stay informed on critical healthcare developments.
