Robert Califf has cleared another stage on his return journey to the top job at the FDA, after the influential Senate committee on Health, Education, Labour and Pensions (HELP) voted by 13 to eight to support his nomination by President Joe Biden.
Califf was nominated by Biden as FDA commissioner last November, ending a search for a permanent replacement for current acting commissioner Janet Woodcock after almost a full year of the new administration.
He led the FDA under the Obama administration in 2016, and garnered a reputation for cracking down on manufacturing and safety, and pushing for modernisation of the regulator before Donald Trump’s election win saw his time come to an end just 11 months later.
If he makes it over the line, Califf will lead an agency having to make difficult decisions over the future handling of the pandemic, affected by a lack of permanent leadership, and facing scrutiny over its handling of the opioid epidemic.
The dissenting votes – from Vermont independent Bernie Saunders, Democrats Maggie Hassan and Edward Markey, and a clutch of Republican senators – suggest that the full Senate vote on Califf’s appointment may not be a foregone conclusion.
Sanders reiterated his concerns about Califf’s consultancy work with pharma companies and the “revolving door” between the FDA and industry, while Hassan and Markey are both from US states (New Hampshire and Massachusetts, respectively) that have been hard hit by the opioid crisis.
Hassan said in a statement that she did not believe Califf would take the action needed to address the FDA’s “inaction…to address opioid misuse and the failure to address issues of labelling guidance for prescriptions.”
Califf has said he will review FDA decision-making on opioid drugs, and he will face other challenges as well.
An advocate of reform of the clinical trial framework, Califf will have to tackle the issue of approving drugs based on preliminary data while a confirmatory trial is carried out – brought to the fore last year when the FDA approved Biogen and Eisai’s Alzheimer’s drug Aduhelm (aducanumab). It’s now facing an investigation into that by the Office of the Inspector General (OIG).
There have been concerns that for many years the industry dragged its heels on those follow-up studies, and the DA failed to take a tough stance on tardy companies. There are signs of change with various cancer drugs losing indications last year, but pressure from within and outside the agency to do more.
After so long without a permanent commissioner however market observers think that the odds are in favour of Califf returning to the role.
“As a former FDA commissioner, Dr Califf is an experienced pick to lead this important agency, and today the committee advanced his nomination in a bipartisan manner,” said HELP chair, Washington Democrat Patty Murray.
“As our nation continues to fight the COVID-19 pandemic, the scientists and experts at the Food and Drug Administration who are working diligently to ensure we have safe and effective vaccines, tests, treatments, and more, deserve a strong leader who will make sure science always comes first,” she added.
A date for the full Senate Vote has not yet been set.
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