By Patrick Cooney, for AMRC
FEDERAL AGENCY NEWS
FDA Announces New Head of CDER and ONPD
On December 3, 2025, the U.S. Food and Drug Administration (FDA) announced that Tracy Beth Høeg, M.D., Ph.D., has been appointed acting director of the Center for Drug Evaluation and Research (CDER). A physician and epidemiologist, Dr. Høeg was a Visiting Scholar at the Massachusetts Institute of Technology Sloan School of Management and practiced physical and interventional spine and sports medicine before joining the FDA as Senior Advisor for Clinical Sciences in the Office of the Commissioner and the Center for Biologics Evaluation and Research (CBER).
As part of its CDER modernization implementation, the FDA also announced a new leader of its Office of Nonprescription Drugs (ONPD). Karen Murry, M.D., will serve as director of ONPD.
White House Seeks Input on Science and Research
On November 26, 2025, the White House Office of Science and Technology Policy (OSTP) issued a request for information (RFI) in the Federal Register posing 13 questions to stakeholders on priorities for modernizing how the federal government supports scientific research, the role of artificial intelligence in accelerating discoveries, and on translating breakthroughs into practical applications. Comments are due no later than December 26, 2025.
Below are a few of the questions for potential comment:
- What policy changes to Federal funding mechanisms, procurement processes, or partnership authorities would enable stronger public-private collaboration and allow America to tap into its vast private sector to better drive use-inspired basic and early-stage applied research?
- How can Federal policies strengthen the role played by small- and medium-sized
businesses as both drivers of innovation and as early adopters of emerging technologies?
- What reforms will enable the American scientific enterprise to pursue more high-risk, high-reward research that could transform our scientific understanding and unlock new technologies, while sustaining the incremental science essential for the cumulative production of knowledge?
- What specific Federal statutes, regulations, or policies create unnecessary barriers to scientific research or the deployment of research outcomes? Please describe the barrier, its impact on scientific progress, and potential remedies that would preserve legitimate policy objectives while enabling innovation.
President Trump Announces Genesis Mission
On November 24, 2025, President Trump signed an executive order establishing the “Genesis Mission,” meant to accelerate science and innovation via artificial intelligence (AI).
The plan is to create what is described as a “closed-loop AI experimentation platform.” This platform will integrate national lab supercomputers, datasets, AI modeling, and — eventually — experimental infrastructures (e.g., robotic labs, advanced instrumentation) to allow end-to-end AI-driven research.
The Secretary of Energy is tasked with implementing the mission, coordinating with the White House Office of Science & Technology (through the Assistant to the President for Science and Technology), other federal agencies, academia, and private partners.
The order envisions public-private collaboration: private companies, universities, and research institutions may partner under cooperative agreements to contribute data, computing resources, and scientific expertise.
Under the order, within certain time frames, DOE must identify: (a) computing, storage & networking resources; (b) data and model assets; (c) research facilities capable of AI-directed experimentation; and (d) initial “science and technology challenges” to tackle.
While the ambitions are large, experts and analysts have already pointed out potential caveats and risks. Although the Executive Order launched the mission, it did not specify a defined budget for Genesis. Critics worry that success may require major investments, and past trends include significant cuts to traditional research funding. Also, because the mission spans national security, energy, materials, and biotech, there are questions about checks and balances, dual-use technologies, oversight, and how access will be managed.
If successful, the Genesis Mission could significantly reduce the time from hypothesis → experiment → result in many scientific domains, meaning faster breakthroughs in energy, health, climate, materials, and more.
The stated focus areas include:
- Biotechnology and health science (i. drug discovery, potentially relevant to lab/medical community)
- Critical materials, semiconductors & microelectronics (industrial / supply chain resilience)
- Nuclear fission & fusion energy (energy security / clean energy)
- Quantum information science (future-tech infrastructure)
- Advanced manufacturing, materials science, and more broadly: national security, energy dominance, and strengthening U.S. technological leadership.
CAPITOL HILL NEWS
Congress in December & January
As Congress returns to Washington for its final legislative sprint of the year, December is shaping up to be both compressed and consequential. With only a limited number of session days remaining, lawmakers face pressing deadlines on a potential year-end legislative package.
Preventing another federal government closure is a priority. Full-year spending bills remain incomplete, making another short-term Continuing Resolution (CR) in late January the most likely outcome. The current CR expires January 30, 2026. Another CR would mean flat funding for NIH, AHRQ, and other science agencies, delaying new initiatives and limiting the launch of multi-year research programs.
Congress may address the enhanced premium tax credits established for the Affordable Care Act marketplace plans, which are scheduled to expire on December 31, 2025. Without intervention, many who rely on these subsidies could see their premiums rising by over 75%, and millions could lose eligibility altogether. In response, lawmakers have introduced several bills to address the concern. With deep political division and limited time, Congress could either extend the credits temporarily, allow them to expire (triggering a “subsidy cliff”), or adopt a compromise that reshapes how subsidies are delivered — each path carrying very different implications for affordability and coverage.
There remains a backlog of bipartisan health care legislation on an array of issues, but limited time could force many of those issues into 2026.
