Richard Padzur to depart FDA following current CDER management shift
After lower than a month in his new function as head of the US Meals and Drug Administration’s (FDA) Middle for Drug Analysis and Analysis (CDER), prime drug regulator Richard Padzur has chosen to retire from the company.
In response to STAT, which first reported the information, Padzur knowledgeable colleagues on the FDA of this determination on 2 December. Whereas Padzur might nonetheless revoke his determination to retire, the present consensus is that he’ll depart the company by the tip of December 2025.
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This revelation comes simply weeks after the FDA appointed Padzur as the brand new CDER head, which coincides with a tumultuous interval for the company – fraught with management adjustments, mass layoffs, drug overview delays and accusations of its politicisation from ex-FDA employees.
If Padzur does determine to hold up his hat, the FDA should begin the hunt for a substitute candidate to move each CDER and the Oncology Middle of Excellence, which Padzur based in 2017.
In a press release on 2 December, John F. Crowley, president and CEO of the Biotechnology Innovation Group (BIO), mentioned Padzur’s FDA exit raised “critical considerations” about management turnover throughout the company.
“We’d like organisational energy and stability on the FDA. This fixed turmoil is undermining America’s management in biotechnology, creating unprecedented regulatory instability and unpredictability,” mentioned Crowley.
He warned that ongoing insecurity on the FDA might threat “ceding the pharmaceutical sector to China,” which is more and more influential as main pharma drug licensing offers involving Chinese language corporations reaches a file excessive.
“It’s crucial that we [the US] retain and recruit scientific experience and powerful management at our well being companies. We’re at a tipping level, and it’s time to proper this ship,” Crowley added.
Throughout his time on the FDA, which begun in 1999, Padzur has had an influential span – engaged on all the things from streamlining oncology approvals to making sure supportive proof on most cancers therapies was obtainable to sufferers.
Padzur was initially designated because the CDER lead following the resignation of the division’s earlier director, George Tidmarsh, after an investigation into his private conduct raised “critical considerations” throughout the company.
Tidmarsh’s departure was one of many many management adjustments endured by the FDA in 2025. In July, Middle for Biologics Analysis and Analysis (CBER) boss, Vinay Prasad, made a shock exit from the company – solely to reassume his place heading CBER upon the FDA’s request lower than two weeks later.
Earlier than Prasad took the helm at CBER, Peter Marks was compelled to resign from his prime place on the division because of ongoing disagreements with US well being secretary Robert F Kennedy Jr (RFK Jr).
In a resignation letter, the previous CBER lead alleged that RFK Jr wished to hunt “subservient affirmation of his misinformation and lies,” primarily associated to vaccine coverage.
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