Provided by Michael Beard, Vice President of Federal and Global Public Policy
The National Organization for Rare Disorders (NORD) recognizes that the departure of the FDA Commissioner is a pivotal moment for the Agency and the patients it serves. At this time of extraordinary scientific advancement, particularly in rare diseases, NORD appreciates the Administration’s continued focus on orphan products. Now is the time to keep up the momentum on key policy priorities, including those reflected in the President’s budget, such as the Priority Review Voucher (PRV) program, which plays a critical role in incentivizing rare disease innovation.
We urge the swift nomination of a Commissioner who is grounded in science, prioritizes medical rigor, and is able to provide the stable, consistent leadership the FDA needs. We look forward to working with the Acting Commissioner and his team during this transition to ensure there are no additional obstacles to the progress that patients and families are urgently waiting for. The stakes are especially high for the rare disease community; patients often have limited or no treatment options, and delays in regulatory review can have profound consequences. We need an FDA that remains steady, evidence-driven, and patient-centered—one that can translate scientific breakthroughs into accessible treatments.
The FDA has long set the global gold standard in regulating drugs, devices, and treatments—making stable, consistent leadership essential. At a time of unprecedented biomedical innovation, the agency must be fully staffed and led with a steady hand to ensure safe, effective therapies are reviewed efficiently and grounded in strong science. This is not a moment for uncertainty, but for decisive action. We look forward to the nomination of an experienced Commissioner who will provide clear direction, uphold scientific integrity, and keep patients—especially those with rare diseases—at the center of the FDA’s mission.
