RFK Jr. asks for public comment on childhood vaccine recommendations

On Monday, HHS Secretary Robert F. Kennedy Jr. published a request for information in the Federal Register asking for public comment on whether vaccine classifications should be adjusted. The public comment period will last 30 days, through Sept. 20.

The request comes after President Donald Trump earlier this month signed an executive order reducing the number of universally recommended vaccines for children and calling for splitting up the measles, mumps, and rubella vaccine into three shots administered at separate medical visits.

In the request, Kennedy asks if there should be new ways to categorize vaccine recommendations. Currently there are three categories: vaccines used universally for all children, vaccines for certain high-risk groups, and vaccines based on shared clinical decision-making.

"Do the current categories unintentionally imply that parental permission, individual consent, or meaningful clinical discussion applies only to shared clinical decision-making recommendations?" Kennedy wrote in the request.

HHS also wants to determine if people understand whether the categories "convey meaningful differences in the strength of evidence" about vaccines and the "magnitude" of their benefits, both individually and to the overall population. The request also asks if the categories leave room for "individual circumstances and values."

"Transparent communication about negative or uncertain features of vaccines may reduce acceptance in the short term but increases trust in health authorities, whereas vague reassurance fails to increase acceptance and reduces trust," the request states.

(Bettelheim, Axios, 8/24; Dunleavy, Fierce Healthcare, 8/24)

Physician group sues HHS and USDA over new dietary guidelines

The Physicians Committee for Responsible Medicine (PCRM), a nonprofit that advocates for plant-based diets and alternatives to animal-based research, has filed a lawsuit against HHS and the U.S. Department of Agriculture (USDA) over the government's new dietary guidelines.

In January, HHS and USDA released new dietary guidelines that advised Americans to prioritize protein and avoid sugary, processed foods, marking the largest change to the guidelines since they were first introduced in 1980.

In their lawsuit, PRCM alleges that HHS and USDA assembled a "secret panel" that was "rife with conflicts of interest" and didn't follow the long-established process for updating the dietary guidelines.

PCRM is asking the court to withdraw the current guidelines and issue new ones following a process complaint with the Federal Advisory Committee Act (FACA).

Trump administration proposes $103K fee for H-1B visas

Last year, President Donald Trump issued an executive order implementing a $100,000 fee for any new H-1B visa petitions, arguing the fee was designed to help combat "systemic abuse" in the H-1B visa program.

However, a coalition of labor unions, religious organizations, and others led by healthcare-staffing firm Global Nurse Force sued the administration over the fee. A coalition of 20 states also sued to end the policy, arguing it would exacerbate shortages of skilled workers including teachers, academic researchers, and healthcare workers. In June, a federal judge ruled that the fee amounted to an unlawful tax and should be voided entirely.

The Department of Homeland Security (DHS) on Monday issued a new proposed rule for H-1B visas that would charge a fee of $103,265 for any workers seeking to gain employment in the United States who are subject to the annual statutory cap. Notably, universities, hospitals, and research-based institutions are exempted from the proposed rule, unlike the original executive order.

The proposed rule states the fee would be used for the federal government's costs of administering the immigration system, including any activities carried out by DHS and the Department of Justice.

"The proposed H‑1B fee is intended to recover the costs incurred across the federal government to adjudicate, vet, and support lawful immigration programs that otherwise must be funded by taxpayers," said U.S. Citizenship and Immigration Services spokesperson Zach Kahler in a statement.

DHS' proposed rule will be open for public comment for 30 days.

(Fields, The Hill,  8/24; Ngo, New York Times, 8/24)

FDA proposes cutting application fees for new drugs with US-based trials

FDA has issued a proposal that would cut new drug application fees for companies that include data from at least one early-stage clinical trial based in the United States in an effort to reshore drug development back to the country. The proposal is part of "America First" incentives that aim to reduce dependence on foreign countries, such as China.

The proposal would offer a 50% reduction for applications that expand the use of an "orphan drug" for a rare condition to a second disease. It would also restrict eligibility for waivers exempting small business from application fees so they explicitly go to U.S. companies.

According to a filing with the Federal Register, Congress is expected to consider these proposals as part of a package of changes to FDA user fees, which expire in September 2027.

Chris Meekins, an analyst at Raymond James, said that Congress has previously been willing to preserve the user fee structure on a bipartisan basis while changing or removing more politically charged provisions. "As a result, we would expect the core [user fee] agreement to remain largely intact, while the America First provisions face some greater uncertainty," Meekins wrote in a note.

Currently, FDA has scheduled a public meeting on Sept. 16 to discuss the user fee reauthorization.

(Bettelheim, Axios, 8/18)