Robert Califf confirmed as FDA commissioner in tight vote

by Stephen Riddle

It’s official – President Joe Biden’s choice for FDA commissioner, Robert Califf, has been confirmed to the role after a narrow 50 to 46 vote in the Senate that relied on crossover Republican votes.

That bipartisan support proved to be essential, with six Republican senators casting their lot for Califf to outweigh the five Democrats who voted against him.

Opponents focused on his ties to the pharma industry and concerns that he would not take a sufficiently tough stance on the opioid crisis, while some pro-life senators also said they were concerned about the FDA’s recent move to make it easier to access the abortion pill mifepristone.

The vote means that Califf will take the top job at the FDA for the second time – having previously served for 11 months in that role under former President Barack Obama – after months of wrangling among lawmakers about his suitability to return to the role.

It also ends a protracted period without a permanent commissioner at the regulator, which has been led on an interim basis for more than a year by long-time FDA staffer Janet Woodcock.

Today, Califf’s confirmation was opposed by a familiar roll-call of Democrat or Democrat-leaning senators, including Vermont independent Bernie Sanders and West Virginia’s Joe Manchin, who spoke against him ahead of the vote.

The slim margin in the vote is a marked contrast to the previous vote in the Senate in 2016, which was passed by a robust 89 votes to four, and came despite Califf being viewed as pretty much a shoo-in for the role when his nomination was first announced.

He secured the backing of the influential Senate Committee on Health, Education, Labour and Pensions (HELP) in December by a 13 to eight vote that made it clear his confirmation was by no means assured.

Faced with the opposition, Califf made a public pledge earlier this month not take up any employment or payment from pharma or medical device companies he interacts with whilst at the regulator for four years after he leaves, twice the usual period for an FDA commissioner.

Califf acknowledged $8 million in stocks of drug companies in his financial disclosure form after being nominated to return to the post by President Joe Biden, and he has had a close relationship with Alphabet-owned Verily Life Sciences that is reported to have brought him $2.7 million in fees.

North Carolina Republican Richard Burr urged his colleagues to back Califf before the vote, saying the FDA had gone too long without a permanent leader.

Califf “will provide the leadership needed to promote today’s biomedical advancements and help to pave the way for tomorrow’s innovation,” he said.

The news was also welcomed by the Friends of Cancer Research patient organisation, which said Calif’s “in-depth work in clinical research and health outcomes research brings lived experience to the agency.”

The next commissioner will have to balance many priorities, including the reauthorisation of the user fee programmes, reform of tobacco and diagnostic test regulations and the development of post-market data to monitor use of medical products. But Califf is up the job, added the group.

“The FDA needs a strong commissioner with broad support at such a crucial time and we believe that Dr Califf is the right person to ensure the FDA keeps pace with science and innovation without sacrificing the safety and efficacy gold standard established by the agency.”

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