After less than a month in his new role as head of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), top drug regulator Richard Padzur has chosen to retire from the agency.
According to STAT, which first reported the news, Padzur informed colleagues at the FDA of this decision on 2 December. While Padzur could still revoke his decision to retire, the current consensus is that he will leave the agency by the end of December 2025.
This revelation comes just weeks after the FDA appointed Padzur as the new CDER head, which coincides with a tumultuous period for the agency – fraught with leadership changes, mass layoffs, drug review delays and accusations of its politicisation from ex-FDA staff.
If Padzur does decide to hang up his hat, the FDA will have to start the hunt for a replacement candidate to head both CDER and the Oncology Center of Excellence, which Padzur founded in 2017.
In a statement on 2 December, John F. Crowley, president and CEO of the Biotechnology Innovation Organization (BIO), said Padzur’s FDA exit raised “serious concerns” about leadership turnover within the agency.
“We need organisational strength and stability at the FDA. This constant turmoil is undermining America's leadership in biotechnology, creating unprecedented regulatory instability and unpredictability,” said Crowley.
He warned that ongoing insecurity at the FDA could risk “ceding the pharmaceutical sector to China,” which is increasingly influential as major pharma drug licensing deals involving Chinese companies reaches a record high.
“It is imperative that we [the US] retain and recruit scientific expertise and strong leadership at our health agencies. We are at a tipping point, and it is time to right this ship,” Crowley added.
During his time at the FDA, which begun in 1999, Padzur has had an influential span – working on everything from streamlining oncology approvals to ensuring supportive evidence on cancer therapies was available to patients.
Padzur was originally designated as the CDER lead following the resignation of the department’s previous director, George Tidmarsh, after an investigation into his personal conduct raised “serious concerns” within the agency.
Tidmarsh’s departure was one of the many leadership changes endured by the FDA in 2025. In July, Center for Biologics Evaluation and Research (CBER) boss, Vinay Prasad, made a shock exit from the agency – only to reassume his position heading CBER upon the FDA’s request less than two weeks later.
Before Prasad took the helm at CBER, Peter Marks was forced to resign from his top position at the division due to ongoing disagreements with US health secretary Robert F Kennedy Jr (RFK Jr).
In a resignation letter, the former CBER lead alleged that RFK Jr wished to seek “subservient confirmation of his misinformation and lies,” primarily related to vaccine policy.
