CDER director Richard Pazdur to retire from FDA

Less than a month after his appointment as director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), Dr Richard Pazdur is exiting the role to retire.

The 26-year FDA veteran is set to finish at the end of December, as first reported by Stat, and the news brings yet another wave of uncertainty to the agency.

John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), said: “Dr Pazdur’s departure raises serious concerns about the repeated turnover in key leadership occurring at the FDA.  We need organisational strength and stability at the agency. This constant turmoil is undermining America’s leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China.

“As BIO has long upheld – it is imperative that we retain and recruit scientific expertise and strong leadership of the highest calibre at our health agencies and that the standards that are the hallmark of these health institutions are upheld and advanced. We are at a tipping point. It is time to right this ship.”

The latest upheaval adds to months of staffing turmoil at the agency that most recently Dr Pazdur replaced Dr George Tidmarsh after the latter’s resignation in November.

August saw another key leader resign. Dr Vinay Prasad exited as head of the Center for Biologics Evaluation and Research (CBER), however he returned to the post two weeks later.

Dr Prasad’s original exit from his then three-month stint in the role occurred the day the FDA lifted the voluntary pause on shipments of Sarepta Therapeutics’  Elevidys (delandistrogene moxeparvovec) in certain patients. The agency however ruled last month for stricter safety labelling requirements on packaging for the gene therapy.