Regulatory turbulence intensified as the FDA reassigned the director of its Office of Orphan Products Development and the U.S. Senate passed a new iteration of the Biosecure Act as an amendment to the National Defense Authorization Act. The orphan‑office reassignment was confirmed to Endpoints News and signals internal personnel shifts affecting orphan‑drug designation processes. Separately, the Senate‑passed Biosecure Act amendment would restrict federal funding and contracting with certain biotechnology companies of concern, a move that could reshape partnerships, vendor selection, and cross‑border collaborations for genomics and synthesis providers. Readers should note: the orphan‑drug office evaluates designation requests that can enable incentives for development of therapies for rare diseases.