10/13/25 BIOSCIENCE BULLETIN

Government Shutdown:

The shutdown that began on October 1 continues with no end in sight. Most Congressional Democrats refuse to support a bill to re-open the government without an extension of the Affordable Care Act subsidies, which is supported by 78% of the public according to polling by KFF. Republicans feel just as strongly about only passing a stop gap measure that is "clean" with no such extensions or policy riders.

Shutdown Impacts on Agencies:

• More than 400,000 civilian staff keep working, however the Reductions in Force (RIFs) firings total 4,200 people across 7 agencies started on October 10 — which is unprecedented as during previous shutdowns, government employees were furloughed then paid once a stop gap bill was enacted.
• 32,000 employees (41%) at Health and Human Services (HHS) are furloughed with ~66% from the CDC and ~75% from NIH are also furloughed.
• Out of about 1,300 CDC workers who were fired on October 10 about 700 were reinstated the next day.
• The FDA has furloughed approximately 14% of its staff, or about 1,942 employees and it is no longer able to accept any new drug applications (NDAs) or biologics license applications (BLAs) that require a fee.
• The Treasury Department laid off 1,446 people.
• The Education Department laid off 466 people.
• The Housing and Urban Development laid off 442 people.
• The Commerce Department laid off 315 people.
• The Energy Department laid off 187 people.
• The Homeland Security Department laid off 176 people.
• Medicare, Medicaid and Social Security all continue to operate, as will operations at the FDA and mission critical work at BARDA and ARPA-H.
• The military's active-duty troops keep working and President Trump promised all service members will be paid during the shutdown by transferring $8 billion from R&D to salaries.
• SBIR/STTR small business grant program was not reauthorized before the new fiscal year started because the Senate failed to advance a one-year extension of the bill that passed the House.
• During the shutdown, the Senate passed the National Defense Authorization Act (NDAA), which includes provisions on biotechnology from the National Security Commission on Emerging Biotechnology (NSCEB) called the BIOSECURE Act. This prohibits American companies from doing business with companies of concern (e.g., Chinese companies) on federally funded projects. The House bill does not include this language so this will be debated in negotiating a final NDAA package that must pass both chambers soon since the new fiscal year has already begun.

 

FY26 Appropriations:

• The recently announced House bill that funds health programs deviated from many of the Trump Administration priorities by cutting discretionary spending at HHS by just 6% (instead of 40%).
• The House bill cuts CDC funding by 19%, level funds NIH at $48 billion, provides $100 million for the Make America Healthy Again (MAHA) Initiative (1/5 of what Trump requested in his budget proposal), offers $3 billion for the HHS Administration for Strategic Preparedness and Response (ASPR), and a slight increase for BARDA. The House and Senate comparisons include:

• House:

  $108 billion for HHS ($7 billion cut)

  $47.8 billion for NIH ($500 million cut)

  $100 million for MAHA initiative  $945 million for ARPA-H ($555 million cut)

  $0 for the AHRQ (100% cut)  $1.1 billion for BARDA ($85 million increase)

  $126 million for ORWH ($26 million increase)

  $7.452 billion for CDC (19% cut with the elimination of funding for programs at the CDC’s Center for Global Health: Global HIV/AIDS, Global Tuberculosis, vaccines)

• Senate:

  $116.6 billion for HHS ($446 million increase)

  $48.7 billion for NIH ($400 million increase)

  $0 for MAHA

  $1.5 billion for ARPA-H (level funding)

  $345.3 million for the AHRQ (level funding)

  $1.015 billion for BARDA (level funding)

  $130 million for ORWH ($30 million increase)

  $9.15 billion for CDC ($5 million cut)

 

CDC Changes:

• Recent CDC hearings included HHS Secretary Robert Kennedy and former CDC Director Susan Monarez — providing very different accounts of recent turmoil at CDC before Senate Committees. Republican Senators expressed concern about political interference and challenged the anti-vaccine efforts, emphasizing again that vaccines are safe and effective and must be accessible.
• Following Minaret's firing, the CDC accepted Advisory Committee on Immunization Practices (ACIP) recommendations that move away from universal inclusion of COVID shots in routine schedule for all adults, and changes the vaccine schedule for toddlers from a combined MMRV vaccine to separate MMR and varicella shots. This is in opposition to the American Academy of Pediatricians.

 

Medical Breakthrough Technologies:

• A bipartisan bill to offer CMS coverage for FDA-designated breakthrough technologies passed the House Ways and Means Committee and was reviewed during a hearing in the House Energy and Commerce Committee.
• The Ways and Means bill excludes coverage for diagnostics.
• The Senate companion bill includes diagnostics but has not passed any committee yet.

 

FDA Changes:

• The FDA announced changes to direct-to-consumer (DTC) advertising and external advisory committee policy. Also draft policies on regenerative medicine were released.
• The agency convened a meeting on September 30 on Onshoring Manufacturing of Drugs and Biological Products following up on Executive Order 14293, “Regulatory Relief to Promote Domestic Production of Critical Medicines.”
• On October 3, the FDA unveiled a new pilot prioritization program to speed up approval review times for generic drug makers that test and manufacture their products in the U.S., including the use of “exclusively domestic sources for API.”
• The Administration announced and then backtracked from imposing a 100% tariff on imported branded or patented drugs. Pfizer, Amgen, and AstraZeneca announced deals with the Administration to reduce their prices to most favored nation (MFN) levels for Medicaid and via a direct-to-consumer platform ’TrumpRx’, in exchange for tariff relief.
• CMS continues to negotiate prices for drugs under the Inflation Reduction Act. A loophole allowing companies to avoid negotiations on some products remains open, while a federal court ruled that CMS can group different products with the same active ingredient as a single product for negotiation.