FDA’s Bad Rap: Pazdur Steps Up as Agency Faces Leadership Turmoil and Regulatory Scrutiny

Richard Pazdur, a long-standing FDA oncology leader, was appointed as the new director of the Center for Drug Evaluation and Research (CDER) following the controversial resignation of George Tidmarsh earlier this month.1345

Pazdur is known for his regulatory innovation, notably expediting oncology drug approvals through initiatives like Project Orbis and modernizing the drug review process.135

He will continue his role as director of the Oncology Center of Excellence (OCE) until a successor is named, and is regarded as a steady, data-driven leader welcomed by industry, patients, and colleagues.1245

Pazdur’s appointment comes during a period of instability at the FDA, marked by multiple leadership departures and public controversies at both FDA and CDC, contributing to an unpredictable regulatory environment.15

Despite his history of streamlining approvals, Pazdur has been willing to withdraw cancer drugs that later proved to lack efficacy or safety, demonstrating both rigor and flexibility in oversight.35

CDER’s previous head, George Tidmarsh, resigned amid internal controversy regarding his conduct and public statements about drug safety, adding to the agency's leadership challenges.145

The FDA has recently introduced a new Commissioner’s National Priority Voucher (CNPV) program under Pazdur's leadership to further speed up drug approvals, aiming to reduce review time for certain drugs from up to a year to as little as two months.1

Analysts and industry voices expect Pazdur’s leadership to restore much needed stability and predictability at CDER, potentially reducing regulatory uncertainties after a period of notable review delays and public criticism of the agency’s decision-making.5

Sources:

1. https://www.pharmaceutical-technology.com/news/fdas-revolving-door-reveals-pazdur-as-new-cder-head/

2. https://www.chron.com/business/article/fda-names-longtime-cancer-scientist-pazdur-to-21165419.php

3. https://www.statnews.com/2025/11/11/richard-pazdur-cder-head-win-for-patients-drug-companies/

4. https://www.biospace.com/fda/fda-stalwart-pazdur-named-tidmarshs-replacement-as-cder-director

5. https://www.biopharmadive.com/news/fda-richard-pazdur-cder-director-appoint-cancer/805242/