Dear President Trump:

As a coalition of biotechnology and pharmaceutical innovators, patient advocates, investors, and physicians working at the forefront of science and medicine, we write at this pivotal moment to recommend a leader who can secure and strengthen the U.S. Food and Drug Administration: Dr. Richard Pazdur.

Decisional volatility, staff exodus, missed deadlines, and eroding scientific predictability at the FDA have created a crisis of confidence in America’s ability to remain a leader in biomedical progress. Solving it requires leadership with proven experience, unimpeachable scientific credibility, and a demonstrated track record of leadership and effectiveness – all qualities Dr. Pazdur has demonstrated throughout his time at the agency.

• Scientific Credibility and Independence: Scientific independence is critical to our entire innovation ecosystem. It requires credibility, the ability to engage substantively with scientific staff, command the respect of the research community, and make evidence-based decisions. Over his 26 years at the agency, Dr. Pazdur demonstrated a track record of credibility, rigor, and results. He streamlined drug approvals, reduced development timelines, and brought life-saving therapies to patients.

• Consistency and Predictability: Investors and drug developers make decade-long bets based on their understanding of the regulatory pathway ahead. When standards shift mid-process or decisions seem disconnected from scientific evidence, capital and innovation disappear. Dr. Pazdur’s appointment would send an unambiguous signal to global markets that America’s regulatory leadership is stronger than ever. He will stabilize new drug reviews, harmonize intra-agency practices, and restore the scientific engagement sponsors, patients, and scientists depend on.

• Proven Institutional Leadership and Operational Excellence: Our next Commissioner must serve as a genuine champion for the Agency and American patients, be capable of managing a large, complex organization, and advocate forcefully for its operational and personnel needs. Dr. Pazdur made the United States the global leader for cancer drug reviews when he founded the FDA’s Oncology Center of Excellence. He built a division that assessed each disease on its own biological terms rather than applying a one-size-fits-all framework. That is precisely the framework that can be applied across all disease states.

Our coalition is not simply endorsing an individual. We are endorsing a set of criteria that any FDA leader must possess: deep regulatory experience, a track record of reform, and the ability to lead a scientific institution under political and competitive pressure without compromising speed or rigor. We stand ready to support the Administration in ensuring this appointment fulfills the FDA’s mission.