Leadership Change at CDER Spotlights Imperative to Name New FDA Commissioner

FDA Acting Commissioner Janet Woodcock announced this week that Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research (CDER), shifting from her role as acting director since spring 2020. While not a surprise, the move makes clear that Woodcock will not return to that position at CDER, which she had held for much of the past 30 years (1).

Instead, Woodcock remains in limbo as the temporary head of FDA, a situation that has been lamented on all sides. Several months ago, she was expected to get the top job until that move drew opposition from certain consumer activists who regard her as too cozy with industry and responsible for permitting deadly long-acting opioids on the market. The situation has led to inaction at the White House, leaving the leadership of FDA as one of the few unfilled top administration positions, a notable concern in this time of public health emergency. Woodcock’s long experience and strong leadership at FDA makes her a prime choice to lead the agency after a year of indecision and errors under Stephen Hahn, who came to the job with little knowledge of FDA or federal government operations. With the COVID-19 pandemic still raging across the United States and the world despite effective vaccines and therapeutics, FDA continues to face difficult decisions as it strives to shepherd new therapies to patients.

In only three years at FDA, Cavazzoni has impressed colleagues and FDA stakeholders for being a capable administrator and creative problem-solver. Woodcock brought her to CDER in 2018 as deputy center director for operations, and she briefly served in 2019 as acting principal deputy commissioner. Before coming to FDA, she held executive positions involving pharmacovigilance and drug safety at Pfizer, Sanofi, and Eli Lilly. In the past year, Cavazzoni kept the drug regulatory process running smoothly, as the pandemic placed added pressures on drug development and approvals, particularly with the halt to field inspections needed to vet product quality.

A main challenge for Cavazzoni will be to explain and reassure Congressional leaders of the strength of various CDER programs and decisions, as the agency continues to face sharp scrutiny for its handling of drug testing and product approvals during the pandemic. CDER will be in the spotlight as it seeks approval of new drug user fee agreements and sufficient resources in the coming months. And with a number of long-term FDA officials poised to retire, Cavazzoni will face the challenging task of recruiting and retaining capable staff under difficult circumstances.

Woodcock was named FDA acting commissioner in January 2021 when the Biden administration took office. In closing her announcement about Cavazzoni, Woodcock acknowledged that, in addition to serving temporarily as the agency head, her official FDA position now is principal medical advisor to the commissioner, the role she assumed when detailed last May 2020 to head therapeutics development at Operation Warp Speed. Under current law, she can serve as acting commissioner only until mid-August, unless she or another person is named to the commissioner’s job. Woodcock could remain at FDA in her medical advisory role under a new commissioner, but it won’t surprise anyone if the chooses to retire from the agency at that time.

Reference

1. J. Woodcock, A Message From the Acting Commissioner, Personnel Update–CDER Director, April 12, 2021.