| |  | | | | |  | By Megan R. Wilson | - Abortion pill showdown: Senate Republicans are urging the Trump administration to “reevaluate” whether newly approved generic mifepristone should be allowed on the market — a move that could sharply limit medication abortions.
- New vaccine schedule scrutiny: A new federal vaccine working group is launching a “multi-year effort” to reassess the childhood vaccine schedule.
- Accountability gap: Most large employers offer mental health coverage, but few check whether workers use it — a missed opportunity, advocates say, to boost productivity and reduce costs through early intervention.
lliwTGIF, everyone, and welcome to Health Brief. I’m Megan Wilson, and I’m your host to this health policy shindig. The Senate out of town until Tuesday, meaning the shutdown is guaranteed to enter into its third week. There have been slivers of optimism — talks of pledges and compromises — but ultimately, no path forward has emerged. For more on this, read Theodoric Meyer’s latest piece for The Post, “John Thune’s shutdown strategy: Wait for the Democrats to fold.” → Breaking: The Trump administration is moving forward with federal layoffs in response to the shutdown. HHS will be impacted — but it’s not clear by how much. In more breaking news, (h/t MSNBC with the scoop) AstraZeneca is the latest drugmaker to cut a deal with the Trump administration on drug pricing. Read The Post’s Dan Diamond on the deal, which will be announced later today. And I’ll be unpacking it for you next week. → Monday, Oct. 13: Indigenous Peoples' Day is a federal holiday, but I’ll still be bringing you an issue of the newsletter on Monday to kick off the week. In the meantime, do you have any tips, scoops or intel? Let’s chat. You can reach me at megan.wilson@washpost.com or on Signal at megan.434. 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. |  | | FDA Commissioner Marty Makary. The agency recently approved a generic version of a drug used in medication abortions, angering conservatives. (Jim Lo Scalzo/EPA/Shutterstock) | | | |  | The Lead Brief | The heat is rising around mifepristone, one of the drugs that’s used in medication abortions. Conservatives and antiabortion groups bristled at the Trump administration’s approval of a new generic version of the drug last week. Now, Senate Republicans are demanding that the Food and Drug Administration “reevaluate” whether it should be sold, expressing safety concerns. “With full confidence in your dedication to protecting women’s health, states’ rights, and unborn life, we urge you to take decisive action to reevaluate whether this generic version of mifepristone is suitable to enter the market,” the letter reads. In the letter, sent to Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, lawmakers also ask that the administration suspend distribution of mifepristone and all generic versions as an “imminent hazard” and reinstate a requirement that the drug must be prescribed in person, which would effectively end all telehealth and mail orders. In questioning whether the drug should be on the market, the senators cite a safety study of the medication that drew criticism for a lack of transparency over its data and the lack of external peer review. → Nearly every Republican in the Senate signed the letter. Sens. Susan Collins (Maine) and Lisa Murkowski (Alaska) did not. “While we recognize the FDA’s statutory responsibility in evaluating drug applications, the timing of this approval appears inconsistent with the comprehensive safety reassessment your agencies have prioritized,” the letter reads. HHS declined to comment on the letter. Following the FDA’s approval of a second generic version of the drug last week, Kennedy took to social media to say that “federal law requires approval when an application proves the generic is identical to the brand-name drug.” (But it’s been pointed out that regulators do have ways of drawing out reviews if they want to, including by requesting more data.) In the post, Kennedy tried to show the administration is committed to questioning the safety of the drug, highlighting a letter he and Makary sent to Republican state attorneys general earlier this year that promised to take another look at whether mifepristone is safe. Medication abortions represent more than 60 percent of abortions in the U.S. health system, according to the Guttmacher Institute. The letter, meant to pressure the administration to take a tougher stance on the drugs, builds on other recent moves that could reduce access to the medication, if successful: - Earlier this week, the state of Louisiana sued the FDA, arguing the agency should reverse a pandemic-era decision to allow mifepristone to be prescribed via telehealth and delivered by mail.
- Last week, a Texas judge filed to move another case involving the regulation of the drug to a federal court in Missouri. The venue change could give plaintiffs — which includes the state of Missouri — a better chance at having their arguments heard.
| | | | | | Immunization Update | A panel of federal vaccine advisers is planning to undertake a “multi-year effort” to review the childhood vaccine schedule, including examining the timing of and ingredients within the shots. The effort is being undertaken by a working group within the advisory panel, the Advisory Committee on Immunization Practices, that makes recommendations to the Centers for Disease Control and Prevention. Their recommendations, if adopted by the CDC, often translate into policy — including whether certain vaccines are covered by insurance. Medical experts have been troubled by ACIP’s trajectory under Kennedy. Early in his tenure, he replaced the panel’s members with his own handpicked selections — many of whom have a history of vaccine skepticism. “The rationale for this [working group] includes considerations such as the use of new vaccine technologies and ingredients, and the rise of vaccine hesitancy,” reads a document outlining the working group’s activities. “These activities should not only be based on past research but also future vaccine studies. If such studies reveal unexpected but scientifically validated concerns, the schedule should be adjusted accordingly.” → ACIP has about a dozen different working groups that review data on different vaccines and make recommendations for the full panel to consider. The new Childhood and Adolescent Immunization Schedule working group will explore many topics, including whether aluminum adjuvants — an ingredient in some pediatric vaccines that boosts immune response — increase the risk of asthma. President Donald Trump has talked about wanting to remove aluminum salts from vaccines, an act that would essentially require the development of entirely new products — which would take years. It has been used in vaccines for decades and thoroughly studied for its safety. | | | | | | Numbers Game | While nearly all larger employers, 97 percent, offer some mental health benefits as part of their employee health plans, a new survey from mental health coalition Path Forward found there is still a ways to go when it comes to making sure those benefits are actually useful to workers. “Employers spend billions on their benefits. By investing just a fraction more on reporting and accountability, they can safeguard their investments and ensure every dollar spent translates into care delivered," Anna Bobb, the executive director of the Path Forward coalition, tells me. The survey, conducted by nonpartisan research nonprofit Employee Benefit Research Institute, asked people with decision-making power over benefits at 400 companies with 500 or more employees about their approach to mental health benefits. The fresh data can give executives a road map of how to improve, the organization argues. → The data: Only 22 percent of employers reported monitoring whether employees are actively using their behavioral health benefits and fewer than half of them evaluated whether the benefits were useful, accessible or cost-effective for their employees. | “When employees use their benefit, they get help when the mental health condition is earlier in its trajectory, easier to treat and more likely to yield a positive outcome." Anna Bobb, executive director of Path Forward. | | | | “When employees use their benefit, they get help when the mental health condition is earlier in its trajectory, easier to treat and more likely to yield a positive outcome,” Bobb said. Concerns about privacy is a barrier, employers say: To assuage privacy concerns, Bobb says employers can gather claims data where the identifying information has been stripped out. Why it matters: “Poor mental health in the work force is widely understood to result in lower productivity, higher turnover, and higher health care costs for employers,” the organization said. Roughly 165 million Americans receive health insurance through their work — making decisions by employers especially consequential. → But what’s covered can be sparse: While more than 70 percent of employers reported offering coverage for therapy or counseling, only 33 percent had coverage for long-term mental health treatment. “The reason to encourage utilization is to flip the switch on mental health care. For too long, mental illness has been stigmatized and pushed into the shadows. Employers can bring mental health care into the light and make seeking mental health care as positive as going to the gym,” Bobb told me. The Path Forward coalition’s members include health care purchasers, clinician associations, health systems, philanthropists and health care nonprofits. It aims to increase access to mental health care and substance abuse treatment. | | | | | | | | | | |
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