On November 12, the President signed legislation to end the government shutdown, reopening the government to normal operations. The agreement includes a continuing resolution funding most of the government until January 31, 2026, as lawmakers continue to negotiate next year’s budget. It also funds SNAP benefits and includes three separate spending bills that provide funds for the Food and Drug Administration (FDA), agriculture, military construction, and legislative agencies for the remainder of the current fiscal year, which ends on September 30, 2026. The package reverses layoffs of federal workers – most of which were CDC and HHS employees – made during the shutdown and includes retroactive pay for government workers.
While the package does not include any funding for the expiring Affordable Care Act subsidies, the Senate has committed to holding a vote before the end of the year on whether to extend the subsidies. As Congress continues to debate FY 2026 funding for key agencies like the National Institutes of Health and the Centers for Disease Control and Prevention, the EveryLife Foundation will continue to update the rare disease community and advocate for the funding of critical programs that our community relies on. Additional details on how the recent agreement affects rare disease programs and initiatives are included in this update.
With the government back to its typical operations, there is a critical window to advocate for time-sensitive legislative priorities. One of those priorities is the reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) Program through the Give Kids a Chance Act. The PRV Program has been expired since December 20, 2024, and each day that passes without Congressional action represents a potentially delayed clinical trial that could bring hope to families.
We are eternally grateful to all the public servants who faced challenging circumstances over the last 45+ days but who continued to push forward with the critical work our health agencies do every day to protect and benefit the rare disease community.
We look forward to continuing to engage with the rare disease community and amplifying your efforts to advance rare disease policy issues. We encourage you to continue sharing your stories. You can also visit the RDLA Action Center to view opportunities to advocate for a number of rare disease policy issues. We are so grateful to this community – your resilience and determination continue to inspire us.
What to know about how the fiscal package impacts the FDA
Overall Report Language Funding Summary:
The package allocates $6.9 billion in funding for the FDA. By including the full FY26 FDA funding bill, the agreement insulates the FDA from any further impact if the government shuts down again prior to September 30, 2026, including $9 million toward cosmetics regulation, $2.5 million for diabetes research, $2 million for the Tobacco Task Force, and $116 million for the State and Local Food Inspections Program. Overall, the FDA’s budget authority is reduced by $105 million, with the Medical and Radiological Devices being the only agency to see an increase in funds. Including the funds from user fees ($84.7 million), the FDA budget authority is effectively cut by $70.3 million.
Rare Disease Community – Specific Report Language:
Per the FDA report, the Rare Disease Innovation Hub will continue to build draft guidance in relation to rare diseases. The Hub was directed to fully implement the 2025 strategic agenda that strengthens collaboration among centers to better address unmet needs in the rare disease community. It also includes language that prompts the development of a Rare Disease Innovation Agenda to further patient participation in the agency in issues such as novel endpoints, biomarker development, use of real-world data, and innovative clinical trial designs.
The report also directs the FDA to continue to support the PRV program framework until it is reauthorized. The FDA bill included other report language that is relevant to the rare disease community, including:
- Oversight requirements that require quarterly FDA Ombudsman Certification for User Fee Agreements. Under this provision, the FDA must provide a 90-day report on maintaining the user’s fee agreements, including an outline of staffing levels and resources used for user fee commitments.
- Encouraging alignment with patient communities on risk tolerance, benefit-risk assessments, adherence to the Orphan Drug Act, and careful use of clinical holds with clear justification.
- Direction to spend an additional $3 million to expand research on neurological diseases, which includes support for hiring additional expert staff.
- Requirements to brief the Committees within 30 days on current drug safety review activities.
What else does the fiscal package do:
Rural Housing: The deal carves out $1.7 billion for rental assistance to support families in rural areas. This is a $73 million increase from last year.
SNAP Benefits: The bill approves a full year of funding for the Supplemental Nutrition Assistance Program (SNAP) that provides food assistance to 42 million low-income Americans.
Agriculture Department: The appropriations package includes $8.2 billion for the Women, Infants, and Children program under the USDA that funds food assistance and nutrition education to low-income women with children under 5 years old. The bill also allocates $460 million to the Commodity Supplemental Food Program, which provides low-income adults over 60 years old with USDA provided food.
Office of Veteran’s Affairs: The bill allocated $153.3 billion in discretionary funding for the Office of Veteran’s Affairs (VA) and defense programs. It provides another $263.7 billion in mandatory funding for veteran’s benefits, significantly increasing the VA’s budget. These provisions include $115.1 billion for VA medical care.
Government Accountability Office: The package funds the Government Accountability Office (GAO) at $812 million, reversing the initial proposed cuts to the office. Congress will also include an additional $203.5 million for enhanced member security initiatives aimed at protecting government officials from political violence.
Defense Programs: The package includes $7 billion for building and upgrading infrastructure labeled essential to troops’ readiness. Also included is $1.5 billion to support the Navy’s Shipyard Infrastructure Optimization Program that aims to modernize four public shipyards. Another $2 billion goes to deploying new technology.
