Axios

The Trump administration's push to reshore drug development is becoming part of efforts to renew the user fee system that pays for review of new medicines.

Why it matters: "America First" incentives the administration is proposing would add a political twist to what's been a bipartisan process, but could gain favor as policymakers look for ways to reduce dependence on China.

The Food and Drug Administration is considering evaluating generative AI-enabled medical devices through a "competency-based approach," similar to how doctors are evaluated, the agency writes in a discussion paper first shared with Axios.

Why it matters: Emerging medical technologies are challenging the existing framework for overseeing medical devices, prompting calls for new approaches.

Public health agencies are communicating in an environment where a large part of the public, across the ideological spectrum, is primed for mistrust.

Why it matters: Effective responses to public health crises like cyclospora require buy in from the public.

The early days of the cyclospora outbreak were dominated by uncertainty about what was safe to eat and what wasn't, with both social and traditional media filled with speculation and panic-inducing headlines.

Why it matters: Today's media ecosystem abhors a vacuum. Whenever there's a lack of official, verifiable information, speculation and disinformation will rush in.

One of health care's biggest administrative hassles — waiting for an insurer's approval for doctor-ordered care — is on the verge of getting a technological fix.

Why it matters: The federal government's long-promised effort to modernize prior authorization is beginning to show up in the software doctors use every day.

President Trump said Friday that he isn't concerned about the state of the USS Abraham Lincoln, despite calls from lawmakers to investigate reports of mental health issues for those onboard.

Why it matters: The San Diego-based aircraft carrier has been deployed for nine months, and numerous reports have indicated that crew members' families are concerned about a lack of food and other basic supplies.

Luigi Mangione pleaded guilty Friday in federal court to stalking charges tied to the 2024 broad daylight killing of UnitedHealthcare CEO Brian Thompson in New York City.

Why it matters: Mangione's lawyers are now using Friday's federal plea to request that all but one separate state charge be dismissed.

What's the common thread connecting AI advances, biological breakthroughs, a preponderance of high-risk-high-reward research, escalating geopolitical tensions and a hollowed-out U.S. public health sector?

• They all heighten the risk that one day a lethal human-made pathogen will emerge, either accidentally or intentionally, and we won't be ready for it.

Why it matters: The same advances that make this a pivotal moment for medical innovation are intensifying the risk of catastrophic lab mishaps, though how significant a risk is hotly debated by experts.

• "It is a very small tweak from trying to target a disease, and making gene therapies to try to target a disease, to turning a virus into something that can be much more detrimental," said Ashish Jha, the Biden administration's COVID response coordinator.
• He has since founded a company that aims to detect emerging biological threats.

President Trump's top political hands had some surprising advice for Senate Republicans last week: Talk more about health care.

Why it matters: Trump and the MAGA base are fixated on the voter-ID and proof-of-citizenship SAVE Act. But Republican message testing from Trump's own pollster suggests candidates are better off focusing elsewhere.

OpenAI's nonprofit arm is committing $100 million toward a public health effort built around using advanced artificial intelligence to help expand treatment rates for Hepatitis C, HIV, and other conditions.

Why it matters: Hepatitis C is curable in more than 95% of patients, but about two-thirds of Americans living with the liver disease remain untreated and about 40 die each day, officials behind the effort said.