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Former FDA commissioners endorse Califf as head of agency, citing urgency of addressing omicron

The nominee will appear Tuesday at the Senate Health Committee’s confirmation hearing.

Robert M. Califf speaks at a news conference in 2016 while serving as FDA commissioner during the Obama administration. President Biden has nominated Califf to lead the agency again. (Andrew Harnik/AP)

Six former Food and Drug Administration commissioners on Monday endorsed Robert M. Califf to lead the agency, saying the emergence of the omicron coronavirus variant is another reminder of “just how critical it is to have a confirmed commissioner” right now.

Califf, a well-known cardiologist and researcher who served as FDA commissioner during the last year of the Obama administration, was nominated for a second stint last month by President Biden. That ended a search that took almost a year, during which an overextended FDA scrambled to review and regulate coronavirus vaccines, tests and treatments — and to navigate other hot-button issues involving Alzheimer’s treatments, opioids and tobacco products.

The former commissioners endorsed Califf in a letter to the Senate Health, Education, Labor and Pensions Committee, which is scheduled Tuesday to conduct a hearing on Califf’s nomination. The panel is not expected to vote until later.

In the letter, the former commissioners, who served in Democratic and Republican administrations, said Califf has “the experience to be effective from day one.” It was signed by Andrew C. von Eschenbach, Scott Gottlieb, Stephen Hahn, Margaret A. Hamburg, Jane E. Henney and Mark McClellan.

Califf, 70, is senior adviser for Verily, a research organization devoted to the life sciences, and Google Health. He spent most of his career at Duke University School of Medicine, where he founded the Duke Clinical Research Institute, one of the largest academic clinical trial operations in the world.

Califf’s nomination is supported by Sen. Patty Murray (D. Wash.), chairwoman of the Health Committee, but opposed by some Democrats who have cited his ties to the pharmaceutical industry and are angry about the FDA’s handling of opioids.

“I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic,” Sen. Joe Manchin III (D-W.Va.) said in a statement in November. “Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards, not forward.”

At Duke, Califf worked closely with drug companies, who footed part of the bill for the research center. He also has consulted for several pharmaceutical firms, including Eli Lilly and Merck.

If confirmed, Califf, who has long argued for better evidence on potential medical products, will almost certainly push for clinical trial improvements and for the increased use of “real-world evidence,” which taps into insurance records, clinical practice and electronic health data to assess how drugs, devices and other interventions work.

The former FDA commissioners praised Janet Woodcock, a veteran drug regulator who has been acting commissioner since January. But they said “the absence of a confirmed commissioner complicates the agency’s ability to undertake and sustain the leadership needed now to protect and promote the health of all Americans.”

Coronavirus: What you need to know

The latest: The CDC has loosened many of its recommendations for battling the coronavirus, a strategic shift that puts more of the onus on individuals, rather than on schools, businesses and other institutions, to limit viral spread.

Variants: BA.5 is the most recent omicron subvariant, and it’s quickly become the dominant strain in the U.S. Here’s what to know about it, and why vaccines may only offer limited protection.

Vaccines: Vaccines: The Centers for Disease Control and Prevention recommends that everyone age 12 and older get an updated coronavirus booster shot designed to target both the original virus and the omicron variant circulating now. You’re eligible for the shot if it has been at least two months since your initial vaccine or your last booster. An initial vaccine series for children under 5, meanwhile, became available this summer. Here’s what to know about how vaccine efficacy could be affected by your prior infections and booster history.

Guidance: CDC guidelines have been confusing — if you get covid, here’s how to tell when you’re no longer contagious. We’ve also created a guide to help you decide when to keep wearing face coverings.

Where do things stand? See the latest coronavirus numbers in the U.S. and across the world. The omicron variant is behind much of the recent spread.

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