What Life Sci Attys Think Of Biden's Pace Choosing FDA Boss

By Jeff Overley
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Law360 (February 12, 2021, 8:59 PM EST) -- President Joe Biden has stoked unease by going several weeks in office amid a devastating pandemic without nominating a permanent leader for the U.S. Food and Drug Administration. But many FDA practice chairs aren't worried yet, telling Law360 that the lack of a Senate-confirmed commissioner has little short-term significance.

The apprehension has appeared in a number of news articles, often in the context of debates over whom the president should name as FDA commissioner. Those debates have centered recently on two apparent finalists: Janet Woodcock, an FDA veteran who has served as acting commissioner since Biden's inauguration, and Joshua Sharfstein, a former principal deputy commissioner of the FDA. 

The anxiety makes sense because Biden has called the pandemic his most urgent priority, and the FDA is responsible for reviewing and authorizing vaccines, therapeutics and diagnostic tests that are essential to ending the coronavirus crisis. But in conversations on Friday, four attorneys serving as chairpersons of FDA practice groups at major law firms told Law360 that the situation isn't alarming right now.

"Is it a problem? I'd say no," James C. Shehan, FDA practice chair at Lowenstein Sandler LLP, said in an interview. "The core of the agency continues to function well, so there's no immediate concern."

Compared to his predecessors, Biden actually isn't behind schedule. Former President Barack Obama officially announced his selection of Margaret Hamburg as FDA boss on March 14, 2009, while former President Donald Trump revealed his choice of Scott Gottlieb to helm the FDA on March 10, 2017.

Current circumstances are different because of COVID-19, which has killed nearly 500,000 Americans and is claiming an average of 2,750 lives in the U.S. each day, according to the Centers for Disease Control and Prevention.

But observers say that Biden has bought himself time to carefully weigh his FDA options by making other high-profile picks for the nation's public health leadership. They include the appointment of Rochelle Walensky, an infectious disease specialist, as director of the CDC and the nomination of California Attorney General Xavier Becerra for secretary of the U.S. Department of Health and Human Services.

Edward John Allera, co-chair of the FDA group at Buchanan Ingersoll & Rooney PC, also singled out former FDA Commissioner David Kessler, who has been named the White House's chief science officer for COVID-19, and Woodcock, who oversaw development of coronavirus treatments during the Trump administration and has served at the FDA since the mid-1980s.

"A lot of COVID-19 issues still exist, and the administration is moving through them methodically," Allera said.

A White House spokesperson had no immediate comment Friday on Biden's timeline for nominating an FDA commissioner.

Attorneys stressed that for the vast majority of companies that deal with the FDA — primarily drug and device makers — the formal nomination and confirmation of a commissioner usually only makes a difference over a substantial period of time. In the short term, most of the impact comes from the rank-and-file staff who process approval applications based on existing statutory criteria.

"The commissioner provides direction and guidance and things of that sort," David L. Rosen, co-chair of the life sciences team at Foley & Lardner LLP, said Friday. "But the good thing is that the agency continues to work hard ... in this very difficult time."

And the broad, strategic duties of a confirmed commissioner might in some ways make a bigger difference after the pandemic. Without the burden of a public health emergency, a political appointee would have a freer hand to change intricate policies, such as how the agency utilizes informal guidance, said Venable LLP partner Claudia A. Lewis.

"On the product approval and policy development front, I predict that the existing infrastructure on these issues will largely operate as is without a nominated commissioner," Lewis, who co-chairs Venable's FDA group, said Friday. "But as we move further away from the COVID crisis, these areas are ripe for the commissioner to implement a new agenda."

Lowenstein's Shehan made a similar point, saying that the primary effect of confirmed leadership is setting in motion long-term policy endeavors.

"That only happens when you have someone who is officially in charge and is going to be there for a while and says, 'This is something new we should do,'" Shehan said.

That reality could be a factor in however long Biden ends up taking to choose his FDA captain. Since the agency's leader will oversee wide-ranging policies for years to come, it might be prudent for the president to spend extra time making his choice, given that there aren't big complaints about the FDA's current performance.

"I would expect that the FDA commissioner is probably a pretty high priority, and they want to make sure that they get the right person in there," Rosen said. "But in the interim, they have good people there that are really doing a nice job."

--Editing by Emily Kokoll and Alanna Weissman.

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