Sunday, July 4, 2021

Biden expands his list of potential nominees to lead FDA as pressure mounts to make a pick: WSJ

Despite facing mounting pressure to pick a permanent FDA commissioner amid the ongoing COVID-19 pandemic, it appears President Joe Biden’s pool of potential candidates is only growing larger. 

The Biden administration has expanded its shortlist of candidates to lead the FDA, which now includes several women of color, The Wall Street Journal reported Wednesday, citing a person familiar with the process. 

While Janet Woodcock, the interim commissioner since Biden took office in January, remains in the running for the permanent job, some politicians and advocacy groups have pushed back on her potential nomination over concerns about past opioid approvals under her watch.

Challengers for the job now include Katherine Luzuriaga, a Filipina-American who is the director of the University of Massachusetts Center for Clinical and Translational Science; Florence Houn, a Chinese-American who has served in leadership positions with the FDA and Celgene Corporation; and Michelle McMurry-Heath, a Black doctor and former Johnson & Johnson executive, according to the Journal’s report. 

The latest batch of names comes after Democratic Sens. Tammy Duckworth of Illinois and Mazie Hirono of Hawaii said they would block Biden’s nominees if he didn’t appoint more Asian-Americans into leadership roles. The senators have since backed down on that threat. 

RELATED: Former FDA chiefs pressure Biden to nominate a new commissioner—and quickly

Gayatri Rao, an Indian-American who previously worked for the FDA and is currently an executive at Rocket Pharmaceuticals, was also named as a potential nominee in the report. Joshua Sharfstein and Luciana Borio, two former FDA officials, are also said to be in the running.

A White House spokesperson declined to comment to FiercePharma’s inquiry regarding the Journal’s report or the status of Biden’s decision. 

Some prominent voices on social media previously speculated that Biden would announce his FDA nominee once his pick for Health and Human Services Secretary, Xavier Becerra, was confirmed. However, it’s been nearly a month since Becerra passed through his Senate confirmation. 

RELATED: Woodcock to step up to interim FDA chief as she and Sharfstein are vetted for permanent job: reports

The wait has frustrated a handful of former FDA leaders, who penned a March letter to the White House urging the president to make his pick. Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, Mark McClellan and Andrew von Eschenbach signed the letter, The Washington Post reported at the time. 

Amid the pandemic, the FDA commissioner post is even more important than normal times, the former commissioners wrote. Vaccine, drug and testing issues are playing out in real time, and the agency still needs to issue tobacco regulations, they added.

While the former commissioners didn’t support a specific candidate, they did praise acting chief Woodcock. Her future at the agency, however, was thrown into question on Monday when Patrizia Cavazzoni was named the permanent director of the FDA’s Center for Drug Evaluation and Research (CDER). Woodcock previously held that position before moving under the Trump administration’s Operation Warp Speed and then into her post as interim commissioner. 

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