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No one individual is responsible for all aspects of an organization as large and diverse as the Center for Drug Evaluation and Research in the US Food and Drug Administration.

But there is also no one person who has had as much impact on shaping what is the model modern drug review organization as Janet Woodcock, who first took over the center a quarter century ago. So the announcement that Woodcock is moving out of CDER to take the lead on FDA’s response to COVID-19 from a post in the commissioner’s office is a very big deal. (Also see "COVID-19 Staff Shakeup: Woodcock Moves to Commissioner's Office As Marks Drops Out Of 'Warp'" - Pink Sheet, 22 May, 2020.)

It is also, in fact, the third time Woodcock has moved up into the commissioner’s office since she first became CDER director in 1994. In 2001, Woodcock temporarily moved into a role overseeing bioterror preparedness after the September 11 and anthrax attacks. Her then-deputy Steven Galson took over as acting CDER director at that point; Galson had just joined FDA earlier in the year from a position at the Environmental Protection Agency. That was a short-term arrangement and Woodcock resumed her CDER duties in 2002.

The next time Woodcock moved up was supposed to be for good. She moved up to oversee FDA’s strategic plan in 2003 and was named deputy commissioner and chief medical officer in 2005, and Galson was named her permanent replacement as CDER director. However, when Galson left FDA in 2007 to become acting Surgeon General, Woodcock moved back into the CDER role – first on an acting basis and the resuming the formal title she has held ever since. (Also see "PDUFA’s Fairy Godmother: Woodcock Steps Into Breach As Acting CDER Chief" - Pink Sheet, 1 Oct, 2007.)

Remarkably, Woodcock oversaw transformative change in CDER during both of her tenures. Woodcock’s appointment in 1994 coincided with the implementation of the new post-user fee review structures at the agency, and under her leadership the drug center adopted review goals as a key management tool, which at the time was almost unthinkable.

When she resumed the CDER role full time in 2008, the drug review center had slipped to a nadir point amid the overwhelming outside focus on drug safety. The return of Woodcock was, in part, intended to restore confidence in the agency with Congress. That has been an extraordinary success.

Woodcock first helped oversee new structures and policies to respond to legislation (and the broader tone of oversight) to emphasize “safety first.” She then helped rebuild the review culture around the ideas of patient input and targeted treatments. She also helped move forward the concept of “breakthrough” designations – embracing the idea that FDA can and should do more to help speed development (not just reviews) of significant therapeutic advances.

The current transition is being triggered under circumstances that are like the 2001 temporary crisis assignment. FDA commissioner Stephen Hahn described the action in temporary terms: Woodcock is “on detail” to the commissioner’s office. “While she focuses on this work,” Hahn said, “CDER deputy director Dr. Patrizia Cavazzoni will serve as acting director.”

However, while the stresses facing FDA are unexpected, the timing for a transition is not unusual or unexpected. Cavazzoni joined FDA in 2018 after 15 years in industry, most recently as a senior VP at Pfizer. She has been viewed as Woodcock’s heir apparent, coming to CDER while Woodcock was in the midst of an overhaul of the Office of New Drugs structure that many saw as a potential capstone project. (Also see "US FDA Taps Pfizer Executive For CDER Deputy Director Slot" - Pink Sheet, 1 Feb, 2018.)

Two years later, the new OND structure has been finalized – with the fourth and final phase of leadership formally announced just as FDA was switching to remote telework amid the COVID outbreak. The outbreak response effort on Capitol Hill also helped complete a key component of the overhaul: FDA finally received new authorizing legislation and user fees to support the OTC monograph review process – a critical step in helping address a low-profile but chronic strain on CDER’s resources. 
( (Also see "OTC Monograph Reform Emerges In Senate Proposal For Covid-19 Economic Relief" - HBW Insight, 25 Mar, 2020.))

In the meantime, Cavazzoni has been able to shape aspects of the OND overhaul (in particular, the new approach to integrating drug safety oversight with pre-market teams at FDA). She also had an opportunity for exposure higher up in the agency during a short period as acting deputy commissioner during the transition from Rachel Sherman to Amy Abernethy at the start of 2019.

In other words, but for the pandemic, a retirement announcement from Woodcock would not be an extraordinary surprise. However, there is no underplaying the challenge ahead if and when the transition from Woodcock to a new CDER director is made official.

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