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Political Pressure at the FDA: An Emerging Norm
Under Robert F. Kennedy Jr.’s leadership at HHS, the tension between career scientists and political figures at health agencies has escalated. This tension is approaching a breaking point at the FDA, as revealed by interviews with over 20 current and former agency officials and legal experts.
This breaking point was reached after FDA scientists received an unusual request in August from the head of the center that oversees prescription medications, seeking information about leucovorin amid Kennedy’s effort to trace the origins of autism by September.
Experts indicate that the push for leucovorin, a generic drug primarily used to mitigate cancer treatment side effects, as an autism treatment signals a potential shift in U.S. drug regulation: one in which political choices take precedence and scientific evidence follows. Discover more about the internal dynamics from STAT’s Lizzy Lawrence.
Aftermath of Friday’s CDC ‘Massacre’
The White House announced on Friday a plan to reduce the workforce at HHS by approximately 1,100 to 1,200 employees. Reports indicate that most of the job cuts occurred at the CDC, particularly impacting disease surveillance and injury prevention sectors. However, a union representing the workforce revealed that over half of these terminations have since been reversed.
A statement from the American Federation of Government Employees Local 2883 confirmed that the layoffs connected to the government shutdown impacted more than 1,300 CDC employees, with over 700 employees being reinstated via email within a day, attributed to errors in job classification coding, according to an HHS official. The union reported that over 600 employees remain terminated.
Notably, the entire editorial team of the Morbidity and Mortality Weekly Report, often referred to as the “voice of the CDC,” was initially affected by the layoffs. Updates are still emerging about the various departments impacted, and we will continue to inform you as more information becomes available. For now, read the full article by my colleagues about the latest upheaval within the nation’s primary health agency.
AstraZeneca and Trump Reach Drug Pricing Agreement
In an effort to uphold his pledge to reduce drug prices in the U.S., President Trump announced on Friday that he has finalized a pricing deal with AstraZeneca.
This agreement is akin to the one negotiated with Pfizer last month, where the British pharmaceutical giant agreed to provide lower prices for the Medicaid program in alignment with rates offered in other developed nations and commit to launching new medications at most-favored nation pricing.
In return, the U.S. will offer the company a three-year exemption from pharmaceutical tariffs tied to national security, granting AstraZeneca time to produce all of its U.S. medicines domestically. The company recently initiated construction of a new $4.5 billion manufacturing facility in Virginia, part of a larger commitment of $50 billion in U.S. investments.
Details about the specifics of the deal remain limited, but what insights are drug pricing experts sharing? Check out the analysis from STAT’s Daniel Payne and Elaine Chen.
LGBTQ+ Clinicians Stand Firm and Plan Ahead
As Alex Sheldon noted, it would be “out of touch” for a professional organization focused on LGBTQ+ clinicians not to address the federal scrutiny targeting the community during its annual meeting. “We have attendees who’ve personally felt the direct impacts of the federal administration regarding the care they provide,” remarked Sheldon, executive director of GLMA: Health Professionals Advancing LGBTQ+ Equity. “It’s somewhat alarming that the atmosphere has had to shift dramatically since last year.”
The previous year’s gathering occurred just before the presidential elections, where the stakes were undeniably high, but “nobody could have predicted the rapid unraveling of our fundamental rights in LGBTQ+ health care,” said Sheldon. This weekend, the organization convened for three days of discussions and presentations aimed at navigating the intersection of resistance to oppressive policies while paving a path towards enhanced care access and evidence-based practice. Enhanced security was in place, with many participants contemplating potential physical threats associated with their presence. Yet the event also included lighthearted activities like drag performances and karaoke.
GLMA has also adapted its approach over the last year. Previously, the organization provided expert insight during litigation; now, it is actively suing the federal government on behalf of its members who have faced research funding loss and obstacles in delivering care. A notable victory occurred in August when a federal district court judge blocked the NIH’s attempt to revoke grants supporting sexual and gender minority health research. — Theresa Gaffney
California Implements Protections for AI Chatbots
Governor Gavin Newsom signed new legislation yesterday, mandating developers of artificial intelligence chatbots to establish safeguards for users and granting them the right to pursue legal action against negligent developers.
This law incorporates several measures, such as prohibiting chatbots from exposing minors to inappropriate content and creating protocols for handling discussions around suicidal thoughts, self-harm, or suicide. California is the first state to put these protective measures in place following numerous reports detailing how AI chatbots can induce delusions, paranoia, and even suicidal tendencies. It is increasingly evident that these technologies can negatively impact mental health, especially for those experiencing psychosis, as I discussed in September.
In related news, my colleague Mario Aguilar reported this morning that Lyra Health will permit its members to discuss their mental health with a chatbot, positioning it as the largest company to integrate a generative AI tool into ongoing therapeutic practices. Read more here.
Declining Coverage in Medicare Advantage Plans
Medicare Advantage plans have gained immense popularity, offering zero-premium options and extensive benefits. However, a decade-long trend of enrollment growth may be facing contraction for the first time in 20 years, according to STAT’s Tara Bannow.
Private Medicare insurers claim that cuts to plans and benefits are necessary due to rising care costs. As Medicare’s annual enrollment period is set to begin Wednesday, beneficiaries will encounter challenging decisions.
Insurers have been reducing plans and benefits for the past few years, a trend that intensified post-COVID-19 pandemic as older adults returned to undergo procedures they previously deferred, such as hip and knee surgeries. Analysts have noted significant cuts among plans offered by Elevance, UnitedHealthcare, and CVS Health, which owns Aetna. Will 2026 mark the turning point? Read Tara’s article for insights.
Current Reads
- They played a role in dismantling Roe v. Wade. Now, their focus shifts to Britain, New York Times
- Cervical cancer eradication is possible. However, Medicaid cuts and anti-vaccine sentiments pose challenges, The 19th
- Elon Musk is quietly re-establishing his presence in the Bay Area, starting with Neuralink, San Francisco Chronicle
- Biden is undergoing radiation and hormone therapy as part of his prostate cancer treatment, Associated Press
- Dancing may provide more benefits than antidepressants, National Geographic
