Advocacy News

On December 4, the Advisory Committee on Immunization Practices (ACIP) will convene and among its agenda items is discussion about the timeline for administration of the Hepatitis B vaccine in infants. In a letter to the Committee, NASPGHAN asked that the universal hepatitis B birth-dose recommendation be maintained.

The panel previously met in September, and, during that meeting, tabled a vote to change current Hepatitis B vaccine recommendations. As drafted, the recommendation is to delay the first vaccine dose until a child is at least one month old if the birth mother tests negative for Hepatitis B. Infants could still receive a dose of Hepatitis B vaccine before one month, but that would be based on shared clinical decision-making.

While NASPGHAN favors more widespread Hepatitis B testing of pregnant women, testing is insufficient and delaying the first vaccine in the series to one month or later creates a window of susceptibility. NASPGHAN further noted even though changes to the vaccine recommendations being discussed by ACIP sound small, “they are not grounded in new evidence and would undo more than three decades of a prevention strategy that has nearly eliminated early childhood hepatitis B in the United States.”

Organizations Ask Lawmakers to Increase NIH Funding

More than 450 organizations, including NASPGHAN, are asking congressional appropriators to provide at least $47.2 billion for the National Institutes of Health (NIH), as well as funding for the Advanced Research Projects Agency for Health (ARPA-H), for fiscal year 2026 — the amount approved by the Senate Appropriations Committee earlier this year.

On November 12, President Trump signed into law legislation ending the government shutdown. That package temporarily extends federal funding through Jan. 30, 2026 for nine of the 12 annual appropriations bills, including the Labor, Health and Human Services, and Education bill, which funds the NIH, while lawmakers complete work on those bills.

White House Reaches Deal to Cut Price of GLP-1s 

On November 6, President Trump announced Eli Lilly and Novo Nordisk will offer their GLP-1 weight-loss drugs at a significant discount. As part of the deal, consumers will be able to buy the companies’ products at a significant discount on TrumpRx when it launches. Ozempic and Wegovy will cost $350, and Zepbound and Orforglipron will be $346. If the Food and Drug Administration approves oral GLP-1 drugs manufactured by either company, their cost will be $150 a month through TrumpRx.

The Medicare prices for Ozempic, Wegovy, Mounjaro, and Zepbound will be $245. State Medicaid programs will also have access to these medications at the Medicare prices.

In exchange for the pricing deal, Eli Lilly and Novo Nordisk are expected to receive a three-year tariff exemption.

NASPGHAN is Listening!  Take our Policy & Advocacy Survey

NASPGHAN is your voice and the leading advocate for pediatric GI. NASPGHAN is updating its national advocacy platform to ensure its advocacy and policy efforts, but first we need to hear from you. Please take a moment to complete a short survey about what you think NASPGHAN’s advocacy and policy priorities should be. The feedback you provide will be instrumental in guiding how NASPGHAN approaches its policy work and will ensure your perspective is heard. Please give NASPGHAN five minutes of your time by completing this important survey.

Organizations Respond to FDA RFI on Defining Ultra-Processed Foods 

In October, NASPGHAN joined with other organizations in sending a letter to the Food and Drug Administration (FDA) as the agency contemplates developing a uniform definition of ultra-processed foods.

The letter emphasized the importance of specialized nutrition products, such as medical foods and formulas, and asked the FDA to not categorize them in the same manner as non-nutrient-dense, conventional foods when considering a definition of ultra-processed foods.

FDA Issues Draft Guidance for Demonstrating Biosimilarity

New draft industry guidance from the Food and Drug Administration (FDA) suggests the agency will change its approach to biosimilar review and no longer require comparative efficacy studies as part of an application for review.

The guidance states that if comparative analytical assessment (CAA) supports a demonstration the proposed biosimilar is highly similar to its reference product, “an appropriately designed human pharmacokinetic similarity study and an assessment of immunogenicity may be sufficient to evaluate whether there are clinically meaningful differences between the proposed biosimilar and the reference product in terms of safety, purity, and potency.”

The FDA has also stated its goal to make it easier for biosimilars to be developed as interchangeable with brand-name biologics.

NASPGHAN is reviewing the guidance which will be open for public comment for 60 days after the draft guidance is published in the Federal Register. Publication has been delayed due to the federal government shutdown.

Administration Issues Clarifying Guidance on H-1B Petitions

On Oct. 20, 2025, U.S. Citizenship and Immigration Services (USCIS) published additional guidance regarding H-1B petitions following the issuance of a proclamation by President Trump on Sept. 19, 2025 that orders prospective employers to pay an additional $100,000 fee for new H-1B petitions for workers abroad, effective Sept. 21, 2025. There is no exception for physicians. The proclamation grants the Secretary of Homeland Security the authority to grant exceptions to the fee in “extraordinarily rare” circumstances. It is unclear whether the Administration will provide exceptions to physicians.

The updated guidance clarifies the proclamation applies to new H-1B petitions and does not prevent any holder of a current H-1B visa, or any alien beneficiary following petition approval, from traveling in and out of the United States.

A federal lawsuit challenging the proclamation was filed October 3. The lawsuit was brought by Global Nurse Force and nine other groups.

NASPGHAN Backs New Indirect Research Cost Model

NASPGHAN, alongside nearly 300 organizations, is asking Congress to support a new model for ensuring that institutions’ essential scientific research costs are adequately supported. The groups are hoping Congress will embrace the work of the Joint Associations Group on Indirect Costs (JAG) and will stop the Office of Management and Budget from instituting arbitrary caps on “indirect costs” or “facilities and administration” (F&A) support for National Institutes of Health (NIH) grants.

On Feb. 7, 2025, the Trump Administration announced it would dramatically cut NIH grants by capping the rate grants pay for “indirect funding” at 15 percent. The abrupt change was opposed by NASPGHAN and others in the medical community. Litigation halted implementation of the policy, although the federal government has appealed the case.

The new model put forward by the JAG  — the Financial Accountability in Research (FAIR) Model — centers on improved transparency and better alignment of indirect cost reimbursement with specific research project needs. The way indirect costs are spread across research at an institution has been targeted by critics who say it allows institutions to evade accountability on how federal dollars are spent.

NASPGHAN Letter to Sens. Cassidy and VanHollen Endorsing the Cure Hepatitis C Act (S. 1941) 

July 28, 2025

NASPGHAN has endorsed the bipartisan Cure Hepatitis C Act (S. 1941), introduced by Sens. Bill Cassidy, MD (R-LA) and Chris Van Hollen (D-MD), that establishes a national program within the U.S. Department of Health and Human Services (HHS) to eliminate hepatitis C (HCV).

The legislation calls upon the Secretary of Health and Human Services to create a national strategy and implementation plan for the elimination of HCV in the United States, which includes the formation of an advisory committee comprised of clinicians, state and local public health officials, patients and other key stakeholders.

The bill creates an innovative purchasing model that authorizes the Secretary of HHS to enter agreements with drug manufacturers for the purchase of hepatitis C treatments. Drugs purchased under those agreements would be provided to registered pharmacies and other dispensing sites and made available to covered populations, including children enrolled in the Children’s Health Insurance Programs (CHIP), without cost-sharing.

The bill also authorizes funding for activities such as outreach to covered populations and screening for HCV.

In its letter, NASPGHAN wrote that early treatment for HCV in children is effective and cost-saving, and that the bill “ensures equitable and uninterrupted access to life-saving therapies during critical windows of early childhood.”

Thank you to Amal Aqul, MD, chair of the NASPGHAN Hepatology Committee, for her valuable contributions to NASPGHAN’s endorsement letter.

Take action now by asking your senator to cosponsor the legislation.

NASPGHAN Responds to FDA RFI on Infant Formula

NASPGHAN has provided extensive input to a request for information from the Food and Drug Administration (FDA) as the agency begins its review of the nutrient content in infant formula. There has not been a comprehensive assessment of nutrient requirements for infant formula since 1998.

In its September 10 letter, NASPGHAN encouraged harmonization between U.S. and European infant formula nutritional standards, including through U.S. adoption of a staged approach that requires different formula nutrient levels at different ages. NASPGHAN suggested the FDA consider a joint panel of European and North American pediatric nutrition experts to provide scientific input to the European Food Safety Authority and to the FDA to accomplish better alignment.

NASPGHAN also provided input on individual formula nutrients and key ingredients, including iron, protein, fats, DHA and ARA, and sources of carbohydrates.

In the letter, NASPGHAN urged the FDA to reinforce with the American public that infant formulas currently marketed in the United States are safe and asked the FDA to also review and update guidance on infant formula labeling and marketing.

In related news, NASPGHAN also recently commented on a draft Agency for Healthcare Research and Quality (AHRQ) comparative effectiveness review: Dietary Total Fat Intake and Dietary Polyunsaturated Fatty Acid (PUFA) Intake and Child Growth and Development Outcomes. In its letter, NASPGHAN underscored, as significant limitations of the AHRQ systematic review, the exclusion of relevant studies and the variability of study methodologies, as well as the lack of focused findings on important subgroups (e.g., preterm infants, individuals with chronic disease, overweight/obesity).

Step Therapy Legislation Reintroduced in Congress

The Safe Step Act  (S. 2903 / H.R. 5509) has been reintroduced in Congress and lawmakers need to hear from you, their constituents, about why their co-sponsorship support of the bill is needed. The legislation would create a clear, timely and transparent process for a patient or physician to request an exception to step therapy protocols in certain situations, including when a patient is already stable on the prescription drug selected by his or her provider. Contact your members of Congress through the NASPGHAN Action Center. It only takes a few minutes to send an email to your lawmakers using a template letter created for you by NASPGHAN. Take Action Now.