Obamacare architect offered FDA job

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The administration struggled for months to find a candidate to head the agency despite its central role in tackling the ongoing pandemic. The FDA is set to issue the first full approvals for Covid-19 vaccines, and is also planning to roll out recalls and play a key role in the development of therapies.

He is also under close scrutiny after suffering a series of reputation blows over the past year, most recently over his decision to approve a controversial Alzheimer’s drug despite little success. evidence of its effectiveness.

Although Emanuel had little experience in drug policy making and had never worked at the FDA, he made allies in the administration due to his experience with the FDA. The Obama administration, for its “vision” of health policy and its broader knowledge of government, said a person familiar with the discussions.

In recent months, Emanuel has been one of the most vocal and prominent advocates of the White House response and vaccination campaign against Covid-19. Most recently, he organized a joint statement by more than 60 medical groups urging health workers to get vaccinated – an effort that won praise within the administration and brought private sector support to a government effort. separate to encourage vaccination requirements.

Emanuel’s supporters in the administration include Biden’s chief medical adviser Anthony Fauci, who supported his inclusion as an FDA leadership candidate, according to three people familiar with the deliberations.

In response to a request for comment, the White House said in a statement that “we have in place strong acting leadership that plays an important role in our response to COVID-19 and beyond, and we look forward to sharing a candidate. with the required expertise. and leadership for this work.

But hours after the article was published, the White House denied it was under review. “Dr. Emanuel is not in the running for this position,” spokesman Kevin Munoz said.

Emanuel did not rule out being interested in the job if asked, but said he had not had any discussions about it.

“I don’t know where this rumor is coming from,” he said, adding that no one in the administration had contacted him.

A trained oncologist, Emanuel is the latest in a series of potential candidates launched for the post of FDA commissioner – a post that has gone vacant for months due to difficulties in finding interested and qualified candidates.

Recognizing the disproportionate importance of the FDA during the pandemic, the administration sought a candidate with extensive experience working within or with the agency, in the hopes of limiting that person’s learning curve. Yet with the Senate equally divided, officials also had to weigh whether their choice would be able to garner enough support to secure Senate confirmation.

“They just have a hard time bumping into someone who is not only good but who wants it, and you won’t have a hard time getting confirmed,” said a person familiar with the discussions. “People who are really good are not particularly interested in it.”

The White House had discussed early on its intention to appoint Acting Commissioner Janet Woodcock as permanent commissioner of the FDA. But the longtime regulator faces stiff opposition from a handful of Democratic senators, including decisive vote Joe Manchin of West Virginia, over his role in past drug approvals that then helped fuel the opioid epidemic.

The controversy surrounding Alzheimer’s drug Aduhelm has also tarnished its image inside and outside the administration – officials feared the episode had heightened perceptions among its critics according to which it is too friendly with the industry that the FDA is responsible for regulating.

Michelle McMurry-Heath, former FDA chief during Obama’s time, was also selected for the post. But she is currently chair of the BIO industry lobby, which could make her hard to sell to progressives. His current role would also expose him to tough questions during the confirmation process over the drug pricing practices of his member companies and raise the same pro-industry concerns that eclipse Woodcock.

Woodcock may remain Acting Commissioner for the next few weeks, after which the post of Commissioner may remain vacant until mid-November and Woodcock may remain in the Commissioner’s office in advisory roles. During those months, the agency is expected to approve Covid-19 vaccines and potentially flesh out its lane for booster injections.

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