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WASHINGTON — Six former FDA commissioners are urging President Biden to quickly nominate an FDA commissioner.

The FDA, which plays a central role in the coronavirus pandemic, has been without a permanent commissioner since January and there’s no telling when that will change. Biden is already on track to nominate an FDA commissioner later in his tenure as president than his two most immediate predecessors.

In the new letter, signed by a bipartisan cadre of former FDA commissioners, including Scott Gottlieb, Robert Califf, Mark McClellan, Margaret Hamburg, Jane Henney, and Andrew von Eschenbach, the commissioners emphasize the central role that the FDA will continue to play in responding to the coronavirus pandemic, and the need to have a confirmed commissioner to guide that work.

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“We urge you to prioritize securing its leadership team, including through seeking the formal nomination and confirmation of an FDA Commissioner. The agency’s experienced staff and its science-based regulatory processes will play a critical role in helping the nation confront the evolving pandemic,” the letter states.

The letter does not explicitly endorse a candidate for commissioner, though it praises Janet Woodcock, the FDA’s acting commissioner and a candidate for the permanent commissioner post.

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“Across Democratic and Republican administrations, we have worked closely with Dr. Woodcock across a range of critical issues. Dr. Woodcock is a highly effective advocate for advancing the FDA’s mission — a role she has continued from her first day as Acting Commissioner,” the letter continues.

Woodcock, a 36-year veteran of the agency and the director of its largest center, has already received endorsements from a large swath of advocacy organizations and some of the nation’s top cancer doctors. However, there are other advocacy organizations and a group of Democratic lawmakers that have opposed her nomination due to her role in the opioid crisis.

  • Accordi g to the HHS stats, about 790,000 death due to drug overdose since 1999. That is more thsn 20 years and of course not ll of these were caused by opioids. The curated nt o as ndemuc claimed now 520,000 so far in one short year and the number is inching upwards.
    Another huge difference is people who died of overdose chose to overdose themselves while those ftom pandemic did not exactly have a choice! Do what is such a big deal about yet to be proven Janet’s opioid fiasco?
    Absolutely nothing wrong at all with a new FDA chief serving the industry for its innovation. Exirbitant drug price ahoy lx be the domain of the legislative branch and not the executive branch. Did we all already forget what Bernie and Elizabeth wanted (Medicare for all)? If Biden gives up on it, who’s fault is it?

  • Personally, I think former HHS official Jim O’Niel should be FDA commissioner. We need someone to shake up the agency and implement much needed reforms like better expanded access, faster vaccine EUAs during pandemics, tiered approval, free-to-choose medicine tracks with a tradeoff evaluation databases, reciprocity with other leading agencies, clearer guidence on how to get medical devices approved, greater transparency into the FDA’s decision making and risk-benefit analyses, and recognition of aging as a disease that can be targeted with drugs and interventions.

  • Just dropping a bomb, Nicholas? No factual info about “her role in the opioid crisis” ? This piece qualifies for the “gossip” label – it is cheap quick hap-hazard shooting-off-the-hip, not real / good journalism.

  • She is not suited to be the Commissioner of the FDA after the Opioid fiasco. There has been extensive discussion on this.

    She would serve innovation (mainly industry) rather than public health.

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