September 2025 Newsletter
Prepared by Van Scoyoc Associates 

National Academies Releases Report on Potential Federal Changes to Research Regulations
On September 3, the National Academies of Sciences, Engineering, and Medicine issued Simplifying Research Regulations and Policies, a report that provides a road map for establishing a more resource-effective regulatory framework for federally funded biomedical research. Read more here.

House Appropriations Committee Approves Labor HHS Bill
On September 9, the House Appropriations Committee approved its FY26 Labor HHS bill along party lines, 35-28. The House bill includes $46.9 billion for NIH’s base budget, $99 million over the FY25 level, as well as $1.66 billion for NIDA, which is the same level included in the Senate FY26 bill and in FY25. Read more here.

FDA Offers Development Roadmap for Non-opioids to Treat Chronic PainAs part of a continuing bid to tackle the US opioid crisis, the FDA on September 10 released draft guidance urging drugmakers to developing safer analgesic products for people living with chronic pain. Comments are due
10. Read more here.

House CJS Bill Includes Language to Block Trump from Rescheduling Marijuana
The House Appropriations Committee on September 10 approved a spending bill that contains provisions to block the Justice Department from rescheduling marijuana. Read more here.

NIH Guidance on Foreign Research Partnerships
On September 12, NIH released a guidance document describing the process for applying for foreign research partnership grants. NIH plans to provide a FAQ document and other resources on this change and has established an email address for questions. Read more here.

Research!America National Health Research Forum Speech and NIH Paylines
On September 17, NIH Director Jay Bhattacharya said during a speech at the Research!America National Health Research Forum that the NIH will no longer use funding cutoff points, also known as paylines, as the primary driver of funding decisions. Watch the speech here.

Senate Sends SUPPORT Act to President’s Desk
On September 18, the Senate passed by unanimous consent legislation to reauthorize the SUPPORT Act. The bill passed the House in June and now heads to the President’s desk for his signature. Originally enacted into law in 2018, the SUPPORT Act authorized grant programs addressing the opioid misuse and overdose epidemic. Read more here.

White House H1B Visa Changes Rattles Health Industry
On September 19, President Trump issued a proclamation which imposes significant changes to the H1B visa program.  The proclamation restricts entry for H1B holders, “except for those aliens whose petitions are accompanied or supplemented by a payment of $100,000”.  Read more here.

NIH Establishes Dedicated Organoid Development Center to Reduce Reliance on Animal Modeling
On September 25, the National Institutes of Health launched an $87 million project to develop a standardized alternative to animal testing that relies on tiny, lab-grown 3D tissue models that mimic the structure and function of human organs. Read more here.

HHS Shutdown Contingency Plan
On September 29, the Department of Health and Human Services (HHS) released its FY 2026 contingency staffing plan, detailing some of the impact of a government shutdown on agency staff and services. Specific to the NIH, the HHS contingency plan includes a list of NIH activities that will not continue.

NIH Information for Extramural Community During Funding Lapse
On October 1, the National Institutes of Health (NIH) issued a notice titled “Information for the NIH Extramural Community During the Lapse of Federal Government Funding.” The notice reiterates some information from the staffing plan and provides some additional information about the status of key NIH activities. Read more here.