Health Affairs January 23, 2026
Editor’s Note
This article is the latest in the Health Affairs Forefront featured topic, “Health Policy at a Crossroads,” produced with the support of the Commonwealth Fund and the Robert Wood Johnson Foundation. Articles in this topic offer timely analysis of regulatory, legislative, and judicial developments in health policy under the Trump-Vance Administration and the 119th Congress.
In February 2025, baby KJ Muldoon was the first person to receive an investigational personalized gene-editing treatment customized to the specific genetic variant responsible for his rare genetic urea-cycle disorder. As the science of individualized therapeutics continues to progress, there are also critical regulatory and economic challenges to resolve.
In part 1 of this article, we described FDA’s broadly flexible approach to meeting...







