The Shutdown that began on October 1 continues. 

With the House in recess until at least next week, the Senate keeps trying to end the shutdown with votes that fail. This is because most Democrats are putting their foot down on requiring an extension of Affordable Care Act subsidies to ensure people can continue to have and afford health insurance (which polling shows 70% of Americans support). Meanwhile Congressional Republicans continue to say no deal and insist on a "clean" Continuing Resolution (CR). The Senate needs 60 votes to pass a CR and although Senators John Fetterman (D-PA), Catherine Cortez Masto (D-NV) and Angus King (I-ME) all voted with Republicans, it is not enough votes. Yesterday, President Trump suggested openness to negotiations with Democrats, amid reports that the Administration officials are worried about substantial spikes in premium costs coming in 2026. However, substantive movement toward of any such negotiation remains unclear.

What does this mean?

Non-essential meetings and functions across government departments have been cancelled or postponed, particularly at agencies of the Department of Health and Human Services (HHS). 41% of the HHS staff is furloughed. NIH has been particularly hit hard. While the NIH’s Clinical center remains open, it is estimated that 75% of staff is not working thereby halting most intramural research activity. Notably, today's NIH Office of Research on Women's Health (ORWH) 25th anniversary event was cancelled along with other advisory council meetings and events. Similarly, while essential disease surveillance and certain vaccination programs continue, 66% of CDC staff are not working. Other HHS agencies remain in better shape. An estimated 86% of FDA employees are continuing to work. At ARPA-H and BARDA, management of critical contracts is continuing due to multi-year appropriations funding these agencies. Lastly, at CMS mission critical functions like Medicare + Medicaid operations continue. 

The White House has threatened that federal workers would lose their jobs instead of being furloughed which is what normally happens during a shutdown. Moreover, earlier today President Trump suggested that workers who remain furloughed may not receive backpay once the government does open, which conflicts with a 2019 law to ensure that federal workers receive backpay. A key milestone is this fight is this Friday, October 10 which is when most federal workers would normally receive their first paycheck of the month. It is suggested that the impetus to come to a resolution will be stronger by October 15, which is when active-duty military members would miss their first paycheck.

After a resolution to the shutdown is reached, both chambers of Congress will have to come together to negotiate a final funding package for federal programs and agencies in FY 2026. This includes agencies critical to non-dilutive life sciences funding like NIH, as well the DoD through the CDMRP medical research grants program. Funding levels proposed in House and Senate appropriations bills involve varied degrees of cuts (very few of which are as drastic as those proposed by the Trump Administration) as well as some increases. 

Stalled Congressional Activity: 

Outside of the fight over the budget and appropriations, broader Congressional activity is also limited, both in terms of moving other bills or holding hearings. Last Tuesday, the Senate failed to reauthorize the Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) Program. Senate Small Business Committee Ranking Member Ed Markey (D-MA) attempted to advance a clean 1-year extension of the program passed by the House. However, Chair Joni Ernst (R-IA) objected and introduced an amendment to facilitate a 1-month program extension, and major program changes including several outlined in her INNOVATE Act bill on SBIR mills, and foreign capture of technologies spun out from US funded research. This measure also failed. Any new SBIR/STTR solicitations will not be released until there is a resolution. Another must pass bill whose exact trajectory remains uncertain is the National Defense Authorization Act (NDAA). The Senate version of this must-pass bill, which includes many provisions on biotechnology recommended by the National Security Commission on Emerging Biotechnology (NSCEB) remains under negotiation but is held up by the shutdown.

Administration Actions:

Much of the Trump Administration’s activity in the past several weeks as been centered on drug manufacturing and drug pricing.  The Trump Administration announced it would impose 100% tariffs on imported branded or patented drugs if companies do not commit to manufacturing in the US.  Notably, the Administration  announced a deal with Pfizer that defers tariffs on the company for three years and creates a new website "TrumpRx" for direct to consumer sales of Pfizer medications at MFN pricing. This deal is directed at patients who lack insurance and includes Pfizer investing $70B in US manufacturing. Amgen followed suit by also standing up a platform for direct-to-consumer sales of its cholesterol drugs via a platform that will be linked to TrumpRx. The FDA convened a public meeting of stakeholders on September 30 on the FDA PreCheck program to accelerate the establishment of high priority new manufacturing facilities of medical products critical to the supply chain. Meanwhile, CMS will keep a loophole open for one more year that allows pharmaceutical companies to avoid price negotiations on products that combine an active pharmaceutical ingredient with other ingredients.

The Administration has also sought to expand its footprint in the cancer space. Last week, President Trump issued an Executive Order for "Unlocking Cures for Pediatric Cancer with Artificial Intelligence" that includes $50 million for the Childhood Cancer Data Initiative (CCDI) in addition to the $50 million it currently receives.

The NIH is moving forward on directives to examine alternatives to animal research. The agency awarded a contract to the Frederick National Laboratory for Cancer Research (FNLCR) to support a new initiative, the Standardized Organoid Modeling (SOM) Center to focus on organoid models of the liver, lung, heart, and intestine, with plans to expand into the brain, thymus, and other disease-specific models. The NIH is also awarding grants to unlock causes of and improve outcomes in autism as part of the $50M Autism Data Science Initiative (ADSI). Thirteen projects were recently awarded funds under this initiative.