Who Will Be the Next F.D.A. Chief?

Two leading contenders generate wider debate about the leadership needed to restore morale and scientific integrity to an agency battered by the politicized Trump administration.

By Sheila Kaplan

One month into his presidency, President Biden still has not named a candidate to head the Food and Drug Administration, a critical position at a time when new vaccines and coronavirus treatments are under the agency’s review.

The glaring vacancy lags behind the president’s selections of most other top government health posts, and has spurred a public lobbying campaign by supporters of the two apparent front-runners, Dr. Joshua Sharfstein, a former high-ranking F.D.A. official and Dr. Janet Woodcock, the acting commissioner.

It has also exposed rifts among Congressional lawmakers, within the public health and medical communities as well as the health and drug industries that depend on the F.D.A. for approval of their products. In particular, some public health officials have used the open position to debate the leadership qualifications needed to restore the agency’s morale and credibility after a year fighting both a pandemic and a president who often belittled the F.D.A.’s process for approving treatments and vaccines.

Administration officials say that Dr. Sharfstein and Dr. Woodcock have gone through at least partial vetting for the job. They attributed the delay to their focus on solving Covid vaccine shortages and distribution problems. They also noted that Xavier Becerra, the attorney general of California and who Mr. Biden has nominated for secretary of the Health and Human Services Department, faces Republican opposition that could jeopardize his confirmation.

Traditionally the incoming health secretary has input on the selection of the F.D.A. chief. This week, however, Mr. Biden nominated Chiquita Brooks-LaSure to run the Centers for Medicare and Medicaid Services, another position that would be part of Mr. Becerra’s portfolio if he is confirmed. A Senate panel is scheduled to hold a hearing on Mr. Becerra’s nomination Tuesday.

Former President Donald J. Trump spent nearly a year using the agency as a punching bag, regularly accusing it, without evidence, of regulatory mischief. He partly blamed the agency for his re-election loss, claiming it intentionally delayed approval of the first coronavirus vaccine. The most recent commissioner, Dr. Stephen Hahn, was widely considered a weak leader, criticized for not protecting the agency’s scientists against President Trump’s withering meddling.

“You’ve got an unprecedented amount of attention on F.D.A. because of the politicization of public health,” said Coleen Klasmeier, a former lawyer at the agency who is the global leader of the food, drug and medical device regulatory group at Sidley Austin. “There’s a real need for someone who can quickly and emphatically restore faith in the F.D.A. as an institution.”

Although the F.D.A.’s top priority is ending the pandemic, the agency has a very expansive reach. Its staff of nearly 17,000 people oversees products that amount to almost 25 percent of U.S. spending on consumer goods including food, prescription and over-the-counter drugs, medical devices, veterinary products, cigarettes, e-cigarettes and other tobacco products. The F.D.A.’s budget for fiscal year 2020 was $5.9 billion, some of which is paid by industry user fees.

It will continue to play a crucial role in the nation’s pandemic response; vetting more vaccines that are in development and under review as well as treatments, protective gear and devices. The agency also monitors the safety of the new vaccines and therapies as they are distributed and administered to the public.

Coronavirus Vaccine Tracker

A look at all the vaccines that have reached trials in humans.

Scott Becker, president of the Association of Public Health Laboratories, has grown impatient about the vacancy, which he hoped would have followed the choice in December of Dr. Rochelle Walensky to head the Centers for Disease Control and Prevention.

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