June 7, 2021 — Despite ongoing speculation about who will be the next Commissioner of the Food and Drug Administration (FDA), “the real leadership story is at CDER,” the Center for Drug Evaluation and Research, according to Kate Rawson, senior editor of Prevision Policy.
As Rawson explained during a June 4 webinar on “What’s Ahead for the FDA? New Leadership, Challenges, and Initiatives,” sponsored by the Coalition for Healthcare Communication, Dr. Patrizia Cavazzoni became CDER Director in April, succeeding Dr. Janet Woodcock. CDER regulates both prescription and over-the-counter (OTC) drugs, including biologic therapies and generics.
Cavazzoni, previously an executive at Pfizer, was hired as Deputy Director in February 2018. When Woodcock shifted positions to take a lead role in the Operation Warp Speed effort to expedite development of COVID-19 vaccines, Cavazzoni was named Acting Director of CDER in May 2020. Her appointment to the permanent position was announced April 12.
Although she was known to have been Woodcock’s hand-picked successor, Cavazzoni has been candid in saying her “job one” is to “win the hearts and minds” of CDER’s staff. Woodcock held this role in two stints totaling 27 years, shaping CDER throughout the era of the Prescription Drug User Fee Act (PDUFA), and is widely respected; Cavazzoni “recognizes she has big shoes to fill,” Rawson said.
Rawson outlined five other priorities for the new CDER Director:
- To guide CDER, which played a large role in the FDA’s emergency response to the COVID-19 pandemic, in rebalancing its work back toward its other important responsibilities.
- To bring to a completion ongoing negotiations with industry over the next PDUFA legislation, due to be enacted by Congress in 2022. In addition to updating the prescription drug, generic, and biosimilars user fee acts, there will be sharp focus on a new program for OTC user fees and monographs.
- To promote greater focus on improving health equity. Cavazzoni has spoken in particular of the potential for generics and biosimilars, especially in insulin products, to help reduce health disparities.
- To continue to focus on the approval process for a large number of drugs addressing rare and neurodegenerative diseases.
- To shore up efforts to secure the supply chain for pharmaceuticals and their ingredients, learning from the shortcomings revealed by the COVID-19 pandemic.
Rawson expects no immediate change in policies at CDER under Cavazzoni, but “as she settles in, we’re going to see where her priorities fall and whether she will be as activist a director as Dr. Woodcock has been.”