With the leadership role of the US Food and Drug Administration (FDA) vacant following Marty Makary’s resignation earlier this week, leaders across the biopharma industry have shared their support for agency veteran Dr Richard Pazdur to take the role as the next commissioner.

Almost 400 biotech CEOS, investment partners, financial analysts, and patient advocates have signed a letter that recommends Pazdur be appointed the new FDA commissioner. Addressed to US President Donald Trump, the signatories state that Pazdur – who spent 26 years at the FDA – has the qualities to quell a period of unrest at the agency.

“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,” the letter states.

A power vacuum currently exists at the top of the FDA, following Makary’s resignation from the role of commissioner on 12 May. Kyle Diamantas, who has been at the helm of the food division, is taking the role of acting FDA commissioner.

While rolling out several important regulatory reforms while in office, Makary’s time at the agency accompanied a period of politicised overhaul. Trump and Makary ultimately could not get past their disagreements over authorisations of fruit-flavoured e-cigarettes and the abortion pill mifepristone.

There has also been instability in other leadership positions at the FDA since Trump’s second term in office. This includes Vinay Prasad, who left his role – for a second time – as head of the Center for Biologics Regulation and Evaluation (CBER) in April 2026.

It remains to be seen, therefore, whether Pazdur will want to re-enter such a volatile environment. The medical doctor previously spent 26 years at the FDA, eventually rising to head of the Center for Drug Evaluation and Research (CDER).  

During his long tenure at the agency, Pazdur implemented several initiatives to expedite oncology drug approvals. For example, Pazdur is a founding director of the Oncology Center of Excellence (OCR) a body that brings together experts to streamline cancer therapy development and reviews. He is also credited with establishing Project Orbis – an international collaborative programme established by the FDA that allows regulatory authorities from international partners to concurrently review and approve promising new cancer treatments.

Pazdur retired from the FDA in December 2025, reportedly unhappy with the direction the agency was headed in under the Trump administration.

At the time, Julie Gralow, chief medical officer at the Association for Clinical Oncology (ASCO), said: “Dr Pazdur will be known as a visionary leader who dedicated his tenure at the FDA to doing everything possible to enhance patient access to safe, effective and improved cancer therapies.”

Ensuring the former-CDER chief puts his name forward or is indeed selected are not the primary aims of the industry-signed letter, however.

It concludes by stating: “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 fulfils the FDA’s mission.”