Biden confirms Califf choice as FDA commissioner

President Joe Biden ended months of speculation by formally nominating Robert Califf as the new commissioner of the FDA, a position he previously held during the Obama administration.

In a statement, Biden said Califf "has the experience and expertise to lead the FDA during a critical time in our nation's fight to put an end to the coronavirus pandemic."

After his 11-month stint heading the agency, Califf returned to his role as a cardiologist whilst also serving as a health policy and strategy advisor to Google's unit life sciences unit Verily and running Duke University's Clinical Research Institute, which he founded in 1996.

The Senate now has to confirm the appointment, but most commentators in the US seem to think that will come through without major opposition, with a number of lawmakers already coming out in favour of his nomination.

Senator Patty Murray (D-Wash), chair of the influential Committee on Health, Education, Labour and Pensions (HELP), has backed Califf, saying he "has led the agency before, and was confirmed last time around in a strong, bipartisan vote."

She added: "I look forward to working with him to see our nation through this pandemic and to tackle other critical challenges like the ongoing opioid crisis, rising youth tobacco use, high drug prices, health inequities, and more."

If confirmed, Califf will lead an agency facing criticism over a lack of permanent leadership, controversial regulatory approvals such as Biogen's Alzheimer's drug Aduhelm (aducanumab), and not standing up to Biden's predecessor Donald Trump who sometimes promoted unsafe COVID-19 treatments.

He would also take the helm as the regulator prepares to make key decisions on COVID-19 and the future role of vaccines and drug treatments.

Some dissenting voices are concerned about Califf's links to the pharmaceutical industry, which stem from his work as a consultant to drugmakers and the funding some companies provide to the Duke centre. He is also on the board of US biotech Cytokinetics.

Others want to see brand new leadership, seeing the many of the current candidates as tainted by past failures. Acting commissioner Janet Woodcock for example has been undermined by criticisms about her handling of the opioid painkiller crisis in the US whilst in charge of the Centre for Drug Evaluation and Research (CDER).

Senator Joe Manchin (Democrat, West Virginia) issued a statement saying that Califf's appointment "makes no sense" in the context of the ongoing efforts by the US to tackle the opioid crisis.

"I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic." he said in a statement. "Dr Califf's nomination and his significant ties to the pharmaceutical industry take us backwards, not forward."

That is a view also shared by Michael Carome, the director of the health research group at consumer advocacy group Public Citizen, which is concerned about "consulting fees totalling tens of thousands of dollars" from list of pharma companies.

"Califf must not be allowed to again pass through the revolving door between the FDA and regulated industries," he said.

"The Senate therefore must reject Califf's nomination and demand that Biden nominate an individual who has been dedicated to advancing public health – one who unquestionably will place the public interest ahead of the interests of FDA-regulated industries."