 | | | | |  | By Megan R. Wilson | - FDA turns up the heat: Federal regulators are requesting more safety information from drugmakers on products meant to protect against RSV and coronavirus, ramping up the scrutiny of vaccines and treatments that haven’t been shown to be associated with severe widespread risks.
- WP Intelligence brief: A new report from WP Intelligence explores how the Trump administration is trying to overhaul care for older Americans using artificial intelligence, potentially opening major new doors for health tech companies — and affecting up to 23 million older Americans.
- Obamacare proposal overview: Lawmakers are barreling toward the expiration of expanded Affordable Care Act subsidies, promising votes on several health proposals. Whether bipartisan consensus is possible remains to be seen.
It’s Wednesday, so welcome to the Health Brief newsletter. Congress only has seven legislative days left on the calendar for 2025, yet appears no closer to resolving the issue of health insurance premiums set to spike for millions of Americans. Do you have any tips, scoops or foolproof solutions able to garner enough bipartisan support on Capitol Hill? Reach out. You can find me at megan.wilson@washpost.com, or message me securely on Signal at megan.434. → For your calendar: Sign up to attend WP Intelligence’s first health policy webinar, happening Friday at 11 a.m. Eastern time. You don’t have to be a WP Intelligence subscriber to join us, so grab a seat for this virtual event. This newsletter is published by WP Intelligence, The Washington Post’s subscription service for professionals that provides business, policy and thought leaders with actionable insights. WP Intelligence operates independently from the Washington Post newsroom. Learn more about WP Intelligence. | | | |  | The Lead Brief | The pharmaceutical industry is grappling with the Food and Drug Administration’s expanding probes into products meant to protect against RSV and covid-19, with some arguing that there hasn’t been evidence of any widespread risks. RSV — The FDA is looking into the safety of two injectable treatments — one from Merck and another from Sanofi — given to prevent babies and toddlers from a respiratory virus called RSV, which is the leading cause of hospitalization for children under 5 years old. The Department of Health and Human Services confirmed it began inquiring about the products in June, but had no comment on the potential timeline for the investigation. Last week, the FDA’s Center for Drug Evaluation and Research — which oversees drug approvals — warned manufacturers on a call that they’d need to give regulators additional information, but Reuters reports that the companies weren’t given more detailed information about what data FDA wants. Asked to clarify what the agency is seeking, HHS told me it has “nothing to share.” “FDA routinely evaluates emerging safety information and will update product labeling if warranted by the totality of the evidence,” HHS spokesman Andrew Nixon said in a statement. Drug regulators are “rigorously reviewing the available data, as it does for all products, to ensure decisions remain rooted in evidence-based science and in the best interest of patients.” Sanofi said in a statement that its RSV treatment, Beyfortus, created with AstraZeneca, has proven safe and effective in more than “50 clinical studies and real-world studies” that included more than 400,000 babies who’d received the shot. Overall, 10 million infants worldwide have been given Beyfortus. “No safety issue has been identified from clinical studies of Beyfortus or from post-marketing experience,” the company said in a statement. “We have extensive safety monitoring processes in place across all our products throughout the entire product lifecycle.” Merck, which makes a RSV treatment called Enflonsia, said the company is “confident” in the product’s safety and its “role in helping to reduce the burden of RSV on infants, families and health care systems.” “We believe deeply in the importance of transparency and welcome ongoing scientific exchange and dialogue with the FDA and other regulatory or health authorities, their advisory committees and scientific leaders,” Merck tells me in a statement. The company said it met with the FDA this month, and is “prepared to answer any questions” about Enflonsia and its safety. CORONAVIRUS — Regulators are broadening an investigation into whether the coronavirus vaccine is linked to deaths, widening the review from just children to whether adults died as a result of the shots, report Daniel Gilbert and Rachel Roubein in The Washington Post newsroom. This follows a leaked internal email from Vinay Prasad, who leads the FDA office overseeing vaccines, that outlined plans to increase the amount of information needed to secure a vaccine’s approval. For example, Prasad notes that manufacturers of certain shots will need to show their product actually reduces disease, not merely generates antibodies to fight it. The email begins with an assertion that agency career staff found “at least 10 children have died after and because of receiving covid-19 vaccination,” without citing specific evidence. The administration said that data is forthcoming, but did not say when. Nixon confirmed to my colleagues that the “FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to coronavirus vaccines.” The Washington Post previously reported that although HHS has defended Prasad’s email, it was not cleared with HHS Secretary Robert F. Kennedy Jr. or the health department. → In safety studies, coronavirus vaccines have generally not been linked to higher death rates. | | | | | | WP Intel File | WP Intelligence’s lead health analyst Rebecca Adams has a new report out focused on the Trump administration’s programs serving as an experiment on the use of artificial intelligence to treat patients enrolled in traditional Medicare who have conditions including depression, obesity and rheumatoid arthritis. → Check out Rebecca’s full report, “Medicare takes AI ‘big swing’” The upshot: While there are still many details that aren’t yet known, it could represent a significant opportunity for tech industry players to get a foothold in the lucrative government insurance program for older Americans and people with disabilities — which can often unlock opportunities for commercial coverage. → The test programs being run by the Centers for Medicare and Medicaid Services could affect approximately 23 million older Americans, the agency told Rebecca. Rebecca talked to one chief executive — Ross Harper, founder of a company called Limbic, which uses AI to triage mental health patients and offers therapy through a chatbot — who flew to Washington from London to learn more about the CMS effort. | “Historically, it’s been really hard to get any scale in the U.S. This is a huge unlock that has the potential to be transformative. … Let’s be candid: The U.S. care market is the single largest health care market in the world.” Ross Harper, founder and CEO of Limbic | | | | → RSVP: On Friday, WP Intelligence is having its first health briefing, featuring a discussion with Rebecca and Andy Slavitt, co-founder of Town Hall Ventures, about the emerging plans for incorporating AI into the Medicare program and the rollout of the Rural Health Transformation Program. We’ll be taking your questions, so send them along when you register for the webinar below. Slavitt, a former Obama administration health official, has some insider knowledge: He told Rebecca that he and others helped CMS Administrator Mehmet Oz vet the Trump administration’s AI initiatives. You don’t need to be a WP Intelligence subscriber to attend the virtual briefing, so make sure to grab a digital seat. | | | | | | Health on the Hill | Here’s a quick catch-up on Capitol Hill’s health policy landscape amid a looming expiration of the enhanced Affordable Care Act premium subsidies that help millions of Americans afford coverage. THURSDAY The Senate is holding votes on side-by-side health policy bills from Republicans and Democrats tomorrow. As of Wednesday evening, both appear doomed to fail. Republicans in the Senate have several plans to address health insurance costs, but leadership has elevated a proposal from Sens. Bill Cassidy (Louisiana) and Mike Crapo (Idaho), who chair committees with jurisdiction over the ACA. The measure includes a number of provisions including putting up to $1,500 into health savings accounts for people with incomes 700 percent of the poverty level, or an income of nearly $110,000 per year for a single person, should they choose to enroll in a high-deductible health plan. → Read the section-by-section summary. Meanwhile, Democrats have united around a measure to extend the enhanced subsidies for three years, but featuring none of the changes some Republicans have said they’d need to gain support — such as a cap on the income of people able to receive the tax credits or enhanced fraud enforcement. → The Congressional Budget Office on Wednesday put out a cost estimate for Democrats’ plan: nearly $83 billion over the next decade. However, it would lead to 8.5 million more people with health insurance over the next four years than there would be if the enhanced assistance lapses. Other Senate offerings include: One from Sen. Roger Marshall (R-Kansas) includes provisions extending the expanded subsidies — while phasing them out over five years and limiting them to 700 percent of the poverty level. Starting in 2027, the subsidy money would be transferred into health savings accounts for people to spend on care. It also proposes requiring identification to mitigate fraud and fund cost-sharing reductions, among other policy changes. Another proposal from Sens. Susan Collins (R-Maine) and Bernie Moreno (R-Ohio) would extend the enhanced ACA subsidies for two years, while prohibiting households with incomes over $200,000 from receiving them. The proposal ends plans with $0 monthly premiums, which Republicans have said drive up fraud. NEXT WEEK — House GOP leadership said there would be more votes on health policies — but no plans as of now to bring up an extension of the enhanced ACA premium subsidies. “Nothing is affordable about the Affordable Care Act, and Republicans want to fix that,” House Majority Leader Steve Scalise (R-Louisiana) told reporters on Wednesday. He said Republicans would be bringing “a number of” health care measures to the floor for a vote, focusing on what committees have been working on. Punchbowl reported that Republicans are teasing action on several policy areas, including the expansion of health savings accounts, reforms of pharmacy benefit managers, increasing price transparency and funding cost-sharing reductions. “Starting next week, voting in the House on bills … will focus on lowering premiums for 100 percent of Americans,” Scalise said during a press conference. Although some of the general topic areas — such as taking aim at PBMs — have garnered bipartisan support, Democrats on the House Ways and Means Committee panned the list of options, arguing the policies fall short of Republicans’ promises to overhaul the health system. — Rep. Brian Fitzpatrick (R-Pennsylvania) is leading a discharge petition introduced today that would force a vote on a measure to extend the enhanced premium subsidies for two years. The plan gives people the option to shift some of the subsidy into health savings accounts and makes other changes to the subsidies. It’s still early, but six Republicans and two Democrats have signed on so far. It needs 218 signatures to advance. NEXT YEAR One Senate Republican health aide told me that January is becoming the target for securing some manner of health reforms. Notably, this is after the enhanced subsidies expire. Scalise also said that he anticipates the work on health policies “that we don’t have full agreement upon” will continue into next year. “We’re going to keep working on those,” he said during the press conference. |  | | American Hospital Association President and CEO Rick Pollack on Wednesday announced his retirement. (Chip Somodevilla/Getty Images) | | | | | | Industry Rx | Rick Pollack, who has led the American Hospital Association since 2015, announced he would be retiring by the end of next year. Pollack has been at the influential industry group for about four decades, helping to shape and grow the group’s advocacy capabilities — including expanding its grassroots network to include hospitals in every congressional district and bolstering AHA’s political action committee that donates to candidates. Pollack’s “leadership guided hospitals through unprecedented challenges and transformations, while also advancing access, quality, and safety,” Tina Freese Decker, chair of the AHA’s board of trustees and CEO of Corewell Health in Michigan, said in a statement. “Our patients and communities have better health care today because of his endless dedication and relentless drive.” AHA spent $18.9 million on lobbying the federal government in the first nine months of 2025, according to disclosures filed to the Senate, the second-highest health-industry lobbying spender behind the group representing large drugmakers. → Executive search firm WittKieffer is conducting a national search for Pollack’s replacement. | | | | |
_tstmp_1756933376-1920-1080.png)
