Biden’s nominee to lead FDA encounters pushback from some Democrats

Joe Biden’s long-awaited nominee to lead the US Food and Drug Administration encountered immediate pushback from some Democratic senators on Friday.

In a statement, the president hailed Robert Califf as “one of the most experienced clinical trialists in the country”, adding that he had “the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic”.

“I am confident Dr Califf will ensure that the FDA continues its science and data drive decision-making,” Biden added.

The nomination of Califf, a cardiologist who previously served as an FDA commissioner during Barack Obama’s presidency, is already proving controversial among critics of large US drug companies on Capitol Hill, particularly those who are outraged by how the actions of the country’s top drugs regulator helped fuel the opioid crisis.

He is considered to have nurtured close ties with the pharmaceutical industry during his previous tenure in Washington. Califf is currently a professor of medicine at Duke University and head of clinical policy at Verily Life Sciences, formerly known as Google Life Sciences.

His nomination was immediately opposed by Joe Manchin, the conservative Democratic senator from West Virginia who holds a crucial swing vote in a Senate that is divided 50-50 between Democrats and Republicans.

Manchin criticised Califf’s ties to the pharmaceutical industry, saying in a statement that the nomination made “no sense” and was “an insult” to families who had battled opioid addiction.

“I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic,” Manchin added. “Instead, Dr Califf’s nomination and his significant ties to the pharmaceutical industry take us backward not forward.”

The FDA has previously come under fire by campaigners who accused the body of exacerbating the opioid epidemic by being too willing to approve new pain medications despite mounting concerns over their safety.

Maggie Hassan, a Democratic senator from New Hampshire, also said she would “thoroughly review” Califf’s record when considering his nomination in the Senate. “I have been deeply troubled by some of the FDA’s past decisions — especially as it relates to the approving and labelling of opioid-based medications — and the FDA has yet to make clear what it is doing to learn from its actions.”

Califf received broad bipartisan support in the Senate when he was nominated by Obama to lead the FDA, and oversaw the approval of some 800 generic drugs by the agency in 2016, the highest annual number at the time. If confirmed, he will take over from Janet Woodcock, who has served as acting FDA chief during the Biden administration.

This summer, the FDA’s approval of a controversial Alzheimer’s drug prompted calls for Woodcock’s removal amid criticism that the medicines regulator is too close to Big Pharma.