Rick Pazdur: FDA Turmoil Creates Opportunity to Rebuild Agency with Industry and Academic Talent

Rick Pazdur, the former top oncology regulator at the Food and Drug Administration, said the damage done under recent political appointees opens a chance for new leadership to restructure the FDA, particularly as China’s drug industry grows more competitive.

Pazdur spoke Friday night at a STAT event during the annual meeting of the American Society of Clinical Oncology in Chicago. The panel also included Matthew Herper, Nicole Gormley, and Harpreet Singh.

Under leaders appointed by the Trump administration, “we’ve had a lot of destruction here, and it doesn’t mean that we have to just go back and say, well, let’s rebuild it as it was,” Pazdur said. “This gives us a great opportunity of — how we want to build it, what staff we want to have, how we want the administrative structure to be,” he added.

Pazdur said the FDA has lost many valuable experts.

He said one way to bolster the workforce is to “think creatively,” such as bringing in academics and people in the drug industry for one- or two-year terms. Elaine Chen, a national biotech reporter who co-authors The Readout newsletter and co-hosts STAT’s weekly biotech podcast The Readout Loud, moderated the discussion.