Will feds weigh in on religious vax carveouts?

Politico

2 days ago

Driving the Day
RELIGIOUS VAX EXEMPTIONS — It's back-to-school season, which means parents are shuttling their kids to pediatricians for annual checkups — and advocates for and against states' exemptions to vaccine mandates for school entry are gearing up for a fight, Lauren reports.
Vaccine skeptics have sought to make their case to the Trump administration's Religious Liberty Commission — created by executive order in May — for executive action to bolster religious carve-outs. But they face pushback from public health experts who warn that more exemptions could threaten public health, setting up another front in the vaccine wars.
Four states — California, Connecticut, Maine and New York — don't offer religious exemptions to school vaccine requirements, and Massachusetts lawmakers are considering banning them. West Virginia provides exemptions after GOP Gov. Patrick Morrisey signed an executive order earlier this year invoking the state's religious freedom law.
Some religious liberty groups have called on the federal government — which has no say in state vaccine mandates — to use federal education funding as leverage to expand religious opt-outs from school immunization requirements, pointing to a Clinton-era religious protection statute.
Precedential web: Some vaccine law experts question how far the executive branch could go to nudge those outlier states toward accepting religious exemptions. The Supreme Court curtailed the Religious Freedom Restoration Act's application to the states in 1997, and administrative conditions on federal funding can't run afoul of Congress' directions.
But proponents say those lawyers ignore more recent opinions that work in exemption advocates' favor, pointing to a Covid-19-era decision lifting in-home gathering restrictions on religious grounds and, more recently, the court's ruling in favor of parents who want to opt their children out of LGBTQ+-themed lessons in public schools.
Shifting winds: The number of kindergarteners entering school with at least one vaccine exemption continues to tick up, with the CDC reporting last week that 3.6 percent had one in the 2024-2025 school year, compared with 2.2 percent a decade ago.
Days before the updated data was released, the American Academy of Pediatrics reaffirmed its opposition to religious exemptions, arguing they should be abolished to protect public health.
'In practice, nonmedical exceptions based on religious belief can substantially limit the public health value of vaccine requirements for school attendance,' the group said in a statement. 'There is no practicable way for schools or other involved community partners to distinguish fairly among religious or other nonmedical claims.'
What's next: The Religious Liberty Commission will hold a hearing next month on public education issues, giving exemption proponents another opening to make their case.
It's unclear where the White House stands on the concept — a spokesperson didn't comment — but the first Trump administration's HHS pursued avenues to grant health care workers expanded 'conscience' protections and to allow imports of certain vaccines due to some patients' religious beliefs.
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Eye on the FDA
NEW TOP LAWYER — FDA Commissioner Marty Makary named a longtime government attorney on Monday to be the agency's chief counsel, months after his first pick was torpedoed by Sen. Josh Hawley (R-Mo.).
Sean Keveney, who most recently served as HHS's acting general counsel, served as a career civil servant at DOJ's civil rights division before becoming deputy general counsel at HHS in 2019, according to the department and his LinkedIn profile.
His predecessor in the position, Hilary Perkins, was also a career DOJ lawyer whose appointment drew Hawley's ire before Makary's confirmation because of her record defending the Biden administration's abortion pill policies. While Perkins also defended the Trump FDA's mifepristone positions, that wasn't enough to overcome his opposition, and she ultimately stepped down days into the job.
MDUFA KICKOFF — The FDA's medical device user fee program is not set to expire until Sept. 30, 2027, but the process to renew it has already begun.
Despite HHS Secretary Robert F. Kennedy Jr.'s vocal distaste for the user fee programs, the Trump administration has made it clear they are committed to the monthslong process that will likely result in their renewal for another five years.
Industry and FDA leaders — including FDA Commissioner Marty Makary and Center for Devices and Radiological Health Director Michelle Tarver — met Monday to discuss the potential sixth iteration of the medical device user fee program.
'While user fees support timeliness and predictability by providing FDA with additional resources, user fees are not a guarantee of approval,' AdvaMed's senior executive vice president, Janet Trunzo, said according to prepared remarks. 'They never have been, and they never should be.'
In Congress
SENATE PASSES FDA FUNDING — Before leaving town for the August recess, the Senate passed a bill to fund the FDA for fiscal 2026 as part of a minibus package by an 87-9 vote. The legislation, which funds the agency at $7 billion, is made up of $3.6 billion in taxpayer funds and $3.4 billion in user fee revenues.
But it is unclear whether lawmakers will have to turn to a continuing resolution before government funding runs out at the end of September. The House Appropriations Committee previously advanced an FDA bill that funded the agency at a lower level.
Research Corner
BOOST FOR WOMEN'S HEALTH — The Gates Foundation said Monday it would spend $2.5 billion through 2030 to speed global women's research into maternal, menstrual, gynecological and sexual health.
Pharma Moves
Erika Sward is now chief advocacy officer at UsAgainstAlzheimer's. She previously was assistant vice president of national advocacy at the American Lung Association.
Document Drawer
FDA Commissioner Marty Makary met with Rep. John Joyce (R-Pa.) for an introductory meeting on July 24. He also met with People for the Ethical Treatment of Animals to discuss nonanimal testing approaches on July 21, according to newly posted public calendar disclosures.
He also met with the leadership team of the Government Accountability Office on July 16 to discuss 'items of mutual interest.'
WHAT WE'RE READING
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