The Citizen Petition That Reads Like Legislative History: ROS1/RET Meets the Precision Oncology Modernization Act November 5, 2026 By Sara W. Koblitz —

https://www.thefdalawblog.com/2026/11/the-citizen-petition-that-reads-like-legislative-history-ros1-ret-meets-the-precision-oncology-modernization-act/?utm_source=rss&utm_medium=rss&utm_campaign=the-citizen-petition-that-reads-like-legislative-history-ros1-ret-meets-the-precision-oncology-modernization-act Last week, Reps. Jake Auchincloss (D-MA) and Morgan Griffith (R-VA) released the Faster Clinical Trials Act, which is intended to “speed the development of new treatments, invest in clinical research, and propel U.S. leadership in biomedical innovation.” Deep inside the bill is a process to update cancer drug labels using genomic evidence to help identify patients who may not benefit from certain treatments. Specifically, Title IV—Precision Oncology Modernization—seeks to establish a process for reviewing and updating the labeling of approved oncology drugs to reflect genetically defined subpopulations. This bill would require the FDA Oncology Center of Excellence to identify oncology drugs for which there is new scientific evidence available pertaining to one or more actionable genetic alterations that is not reflected in the approved labeling of the drugs and establish a process to encourage voluntary labeling supplements—to be reviewed in 180 days—incorporating genomic exclusion criteria pursuant to the Agency’s section 505(o) authority. “Genomic exclusion criterion” is defined as a labeling statement specifying that a drug is not indicated for, or should not be used in, patients whose tumors harbor a specific actionable genetic alteration for which an alternative approved targeted oncology therapy exists.