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Restructuring-COVID-19

The latest staff shakeup at the US Food and Drug Administration to fight COVID-19 will likely make better use of senior career staffers in tackling the pandemic than a plan laid out just a week earlier, experts say.

Center for Drug Evaluation and Research Director Janet Woodcock is moving temporarily to the commissioner’s office so she can be solely focused on Operation Warp Speed, the US effort to facilitate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics. (Also see "Trump’s ‘Warp Speed’ Initiative Could Fund 3 to 5 Large-Scale COVID Vaccine Trials" - Pink Sheet, 17 May, 2020.)

Woodcock’s deputy, Patrizia Cavazzoni will serve as acting CDER director in her absence. 

Meanwhile, Center for Biologics Evaluation and Research Director Peter Marks is moving back to his CBER position full time, no longer leading up the vaccine efforts of Warp Speed, Commissioner Stephen Hahn announced late Friday.

FDA said no one at the agency will be replacing Marks as head of vaccine efforts for Warp Speed, but did not reply to a question about whether someone outside the agency will step into that role.

The complex structure of Warp Speed likely means the program can sustain its efforts even if no one replaces Marks at all, and the move could even help eliminate complexities, even as it reduces the available expertise.  (Also see "Too Many Generals? The Potential Downside Of ‘Operation Warp Speed’" - Pink Sheet, 19 May, 2020.) 

Marks' return to CBER full time will leave just one – but an exceptionally capable – FDA career official on Warp Speed, while giving that official more ability to focus on that role. At the same time, it reverses an earlier decision that would have left CBER short of needed leadership to review COVID vaccines, former senior FDA officials told thePink Sheet. The announcement comes just a week after both Woodcock and Marks were given leadership roles on Operation Warp Speed. 

Former FDA associate commissioner Marc Scheineson said the quick change is likely a result of the White House’s often chaotic response to the virus.

“Lots of decisions seem to be made on the fly and then more experienced minds get together and refine those policy announcements,” said Scheineson, co-chair of Alston & Bird’s food and drug law practice. “I think that’s a little of what’s happened here. I think they’ve decided based on personalities and skill sets, what they need at this immediate time and who can best perform those services.”

Marks Needed At CBER

Marks move means that he will no longer have to recuse from regulatory matters “that have a nexus to COIVD-19,” FDA told thePink Sheet.  The agency said it conducted a legal review and concluded that Mark’s involvement in setting up Warp Speed, which Hahn noted has occurred “over the past few months,” does not necessitate him having to stay out of CBER product review decisions as the commissioner had previously said in a 17 May staff memo. (Also see "Woodcock, Marks Recusals From COVID-19 Product Reviews 'Protect FDA's Reputation'" - Pink Sheet, 19 May, 2020.)

“They need him back at the fort to process these vaccine applications once they are completed and submitted,” said Scheineson.

Peter Lurie, former Associate Commissioner for Public Health Strategy and Analysis at FDA, said it would have been "a pity," if Marks could not have been involved in "what could be one of the most momentous decisions" that CBER will make. Lurie, who is currently president of the Center for Science in the Public Interest, said he believes a more junior CBER staffer should be on Warp Speed. He also believes Woodcock should still be involved in CDER reviews during COVID-19.

But CDER "has a lot more depth in application review," than CBER, said Scheineson, who felt Woodcock has set up that center in a manner that can function well without her. In comparison, Marks recusing himself might have left CBER without "the bench strength that they need," particularly when working on an expedited timeline, Scheineson added.

Woodcock Is 'Switch Hitter'

For Woodcock, the move to the commissioner's office will mean fewer distractions, so she can focus on COVID-19, Scheineson said. And it will put her "a lot closer to Hahn and the White House."

Woodcock is no stranger to the commissioner's office, having spent two years there between her stints leading CDER. (Also see "Woodcock Stays At CDER: Drug Center’s Gain Is FDA Science Program’s Loss" - Pink Sheet, 17 Mar, 2008.)

She also spent time at CBER earlier in her career and has vaccine experience, making her well-suited for the wide array of work of Warp Speed, said Howard Sklamberg, former FDA deputy commissioner for global regulatory operations and policy, and now a partner at Arnold & Porter Kaye Scholer LLP.  

“She is the quintessential switch hitter in that she obviously has deep technical background in drugs, she also has background in vaccines, and she has a lot of experience on the operational side at FDA, and interacting with all kinds of stakeholders,” Sklamberg said.

It would be very hard for her to have a large role in Operation Warp Speed while simultaneously leading CDER, he added.

Woodcock brings with her the ability to communicate to a wide array of audiences, including the general public in a way that people understand. “She has credibility on Capitol Hill from both parties," Skalmberg said. "She has credibility within the medical community. And even some people who criticize her from time to time recognize her expertise."

But the move will mean CDER will be without Woodcock as FDA kicks off the next iteration of user fee discussions with a public meeting on 23 July.

Lurie argued Woodcock might have been able to stay in CDER and be just as involved in Operation Warp Speed. “It’s not my experience that Janet Woodcock has a difficult time getting commissioners’ attention,” he said.

But her move may be a way of signifying “to the rest of the world or to the White House,” that they are taking COVID-19 seriously. “It might be way of saying ‘look, we elevated this,'" Lurie said.

Notably, Hahn publicly announced the changes first on Twitter. (Also see "COVID-19, The US FDA – And Twitter" - Pink Sheet, 21 May, 2020.)

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