Opinion: Biden needs to step up and nominate an FDA commissioner
Enough with the waiting. President Joe Biden needs to embrace the FDA during this pandemic and kickstart the Senate confirmation process for the next permanent commissioner.
And this needs to happen quickly. There are plenty of qualified candidates for the role outside of acting commissioner Janet Woodcock and Josh Sharfstein. Biden needs to move fast not because the biopharma world struggles with even the perception of FDA uncertainty (it does), but because thousands of FDA employees have been dealing with four years of political smears while putting in overtime to review thousands of Covid-19 drug and vaccine trials, and to authorize three safe vaccines in record time.
Their hard work should be repaid with some good news and longer-term direction, and it’s time the public saw statements and comments from the FDA commissioner, not the acting commissioner.
The political pressure and name calling (Trump once referred to the FDA as a “big, old, slow turtle,”) have come and gone. Now, the FDA must wait (coming up on three months, plus at least another couple for the confirmation process) before they get an official leader and political staff they can look to for encouragement rather than embarrassment from former FDA commissioner Stephen Hahn’s exaggeration of the benefits of convalescent plasma and subsequent apology tour, and the firing of a former Washington Times editor turned communications leader just 11 days into the job.
As many at the agency have explained in public and private, it doesn’t really matter who’s at the very top (unless it’s Scott Gottlieb, everyone at FDA adores Dr. Gottlieb) because the commissioner’s job is mostly about serving as the public face of the agency, and less about driving the daily agenda, most of which is set months and years in advance.
But it does matter that there’s someone in that top slot who’s a champion for public safety, competent and who understands how the agency works, and what that role can and cannot do. No one wants an FDA commissioner who needs to learn the ropes over the first 3-6 months, only to leave after a year.
So what’s the hold up for Biden?
For a president who has made clear his intention to remove his predecessor’s political traps around public health, and to resurrect the battered CDC, Biden remained mum on FDA and his failure to name FDA’s permanent commissioner seems to be very much about politics.
At least four Senate Democrats – Maggie Hassan of New Hampshire, Ed Markey of Massachusetts, Joe Manchin of West Virginia and Catherine Cortez Masto of Nevada – have pre-empted Biden’s nomination and voiced their opposition to the leading contender for the job, Woodcock.
The opioid epidemic remains at the forefront of some of the senators’ minds, and rightly so, considering the devastation across the country. Others have raised concerns on industry influence, but Gottlieb did a solid job of showing how prior industry experience does not necessarily reflect on life as a commissioner.
What those senators fail to account for in their opposition to Woodcock is that the FDA is well past the days when a commissioner is making unilateral decisions for the entire agency, or when industry influence might tip the scale. The biopharma industry owns the scale. Almost 70% of the FDA’s budget for drugs is from industry user fees. Working with industry isn’t just in the job description, it’s a large part of the reason FDA exists now. But it’s the other, much more important part of FDA’s role, the part where the FDA protects the American public and Americans can trust the voice of the commissioner. That should push Biden to move forward with a permanent commissioner.