When a federal agency reverses course, the Supreme Court has a test to determine whether that agency action is impermissibly “arbitrary and capricious.” FCC v. Fox Television Stations, Inc., 556 U.S. 502 (2009), set the current APA standard for review of federal agency flipflops. While no “heightened standard” exists under the APA for reversals of
CODEX ALIMENTARIUS: Main Outcome of the 34th Committee on General Principles (CCGP34)
The 34th session of the Codex Alimentarius Committee on General Principles (CCGP34) successfully addressed all topics on its agenda. CCGP34 endorsed several proposed key changes to the Procedural Manual of the Codex Alimentarius Commission relating to (a) the guidelines for Codex subsidiary bodies (Committees and Task Forces), (b) inconsistencies in language used in the main
AI, Algorithms and Abstract Ideas: Federal Circuit Reinforces Limits in Recentive v. Fox
In April, the Federal Circuit issued a significant patent law ruling involving artificial intelligence. In Recentive Analytics, Inc. v. Fox Corp, the Court addressed a core question facing many AI-driven businesses: When are solutions applying machine learning to real-world problems inventive and patentable? The Federal Circuit affirmed the trial court’s dismissal of the underlying
FDA Commissioner Outlines Priorities in JAMA Article
- On June 10, 2025, FDA Commissioner Marty Makary and FDA CBER Director published an article in JAMA that listed their “priorities for a new FDA.” These priorities included accelerating drug development, using AI for scientific review, “healthier food for children,” “harnessing big data,” and reducing patient costs.
- The JAMA article pointed to FDA’s “phase-out” of
What to Watch: FDA Shifts Attention on Artificial Intelligence
In an interesting and somewhat unexpected turnabout over the last six months, FDA has pivoted its focus from regulating industry’s use of artificial intelligence (“AI”) to how the agency itself utilizes AI. This internal shift marks a departure from FDA’s development of AI guidance over the last few years.
Impact of the Leadership in Critical Technologies Act on U.S. Artificial Intelligence, Semiconductors and Quantum Computing
On the heels of the recent reintroduction of the PERA and PREVAIL Acts of 2025, a bipartisan group of lawmakers in Congress has introduced the Leadership in Critical and Emerging Technologies (“CET”) Act. The goal of the Leadership in CET Act is to “encourage innovation by, and the leadership of, the United States with
How Can We Trust What We Don’t Understand?
I’ve been thinking about a question raised by Dario Amodei, CEO of Anthropic, in his recent piece, “The Urgency of Interpretability.” He writes about the increasing power of artificial intelligence systems and our unsettling lack of insight into how they actually work. The models are getting stronger. Our ability to understand them is not.
This
MAHA Report Cites Nonexistent, likely AI-Generated, Studies
- As we previously blogged on May 23, 2025, the Make America Healthy Again (MAHA) Commission published its report detailing what it claims to be the main causes of chronic diseases. The report is receiving increased scrutiny after News of the United States (NOTUS), a nonprofit digital news site, published an article on Thursday,
FDA Shifts Inspections to States and AI to Help Boost Efficiency
- After a slowdown in FDA inspections during the first quarter of 2025 and the mass departure of over 3,500 employees, FDA is pivoting to state authority and generative AI technology to help the agency “do more with less.” FDA currently has contracts with forty-three states and plans to expand this program to have more states
Reflections on the FDLI 2025 Annual Conference – Differing Tones, Shared Goals
From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of sound bites, featured two standout sessions: Food and Drug Administration (FDA) Commissioner Dr. Martin A. Makary on Day 1 and