Richard Pazdur will retire from the Food and Drug Administration only weeks after being named the head of its main drug review office.
A spokesperson for the FDA confirmed that Pazdur, the director of the Center for Drug Evaluation and Research, has submitted paperwork to retire at the end of December. The news was first reported by Stat News.
“We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” the spokesperson wrote in an email to BioPharma Dive. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients. His leadership, vision, and dedication will continue to shape the FDA for years to come.”
Published reports have indicated Pazdur could still reverse his decision. If not, however, his departure would add to what’s already been significant turnover among the leadership ranks of the nation’s top drug regulator.
Since the beginning of the second Trump administration, multiple key officials have resigned amid mass layoffs and reports of a toxic environment. Vinay Prasad, a longtime critic of the agency, was named the leader of the FDA office that evaluates vaccines and gene therapies in May, quit two months later and quickly took the job again. George Tidmarsh was hired to run CDER in July but resigned in November amid a probe into his conduct.
The agency has, along the way, become more unpredictable to industry watchers in terms of regulatory reviews. Though the FDA has announced multiple initiatives designed to speed drug development, it’s also shifted its stance and surprised certain companies that believed their applications to be on track. Some Wall Street analysts have detected an uptick in delayed drug reviews. And the regulator has also drawn criticism for certain drug rejections as well as a new type of voucher program some lawmakers have likened to a tool of “political favoritism.”
Pazdur’s appointment, though, was seen as a potentially stabilizing force. He’s worked at the FDA since 1999 and was the founding director of the Oncology Center of Excellence in 2017. At the agency, he led a series of initiatives to streamline the approval of new cancer medicines, but also held firm on supportive evidence and pushed for treatments to be withdrawn when necessary.
Pazdur is “arguably the most qualified candidate in the entire healthcare ecosystem for this role,” wrote RBC Capital Markets analyst Brian Abrahams, when he was hired. “We also see a low likelihood of controversies or negative headlines that in recent months may have spooked some healthcare investors.”
Since then, biotech stocks have continued an extended rally. But according to The Washington Post, Pazdur has also expressed concerns about that same voucher program as well as other moves the FDA has been making to accelerate drug development.
That he’s now decided to possibly retire is a “significant, sudden and surprising turn” that “raises concerns over the future direction” of CDER as well as the FDA’s “ability to maintain its current pace of progress,” RBC’s Abrahams wrote, in a new note on Tuesday. Should Pazdur ultimately leave, the main question for biotech is whether his successor will be someone with significant regulatory or industry experience, or an “out-of-the-box selection from the MAHA sphere.”
Overall, “the departure of this well-respected leader adds uncertainty and is a net negative for most of the sector,” Abrahams wrote, adding that “it would not be unreasonable” for Commissioner Martin Makary’s tenure to be “on shaky ground.”
