Biden nominates Robert Califf to lead the FDA once more

President Biden on Friday nominated Dr. Robert Califf to be the next commissioner of the Food and Drug Administration, a position he held during the Obama administration.

The nomination, however, quickly hit a snag with at least one of Mr. Biden’s Democrats in the Senate.

Dr. Califf, a longtime cardiologist, had been widely viewed as the favorite for the position in which he will lead the administration’s COVID-19 vaccination effort.

“I am honored to be nominated by President Biden for this position at a critical time for our country,” Dr. Califf said in a statement. “There’s a lot of work to do, and if confirmed I look forward to rejoining the great team at the FDA to help in their inspiring mission to serve the public.”

In a statement announcing the nomination, Mr. Biden urged the Senate to swiftly confirm Dr. Califf.

“Dr. Robert Califf is one of the most experienced clinical trialists in the country, and has 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,” Mr. Biden said.

Some on Capitol Hill have already expressed reservations.

Sen. Joe Manchin, West Virginia Democrat, said he opposes Dr. Califf’s nomination, adding that the nominee’s ties to the pharmaceutical industry won’t make him strong enough to tackle the opioid epidemic.

“Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward,” Mr. Manchin said. “His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction.”

“I urge the Administration to nominate an FDA Commissioner that understands the gravity of the prescription drug epidemic and the role of the FDA in fighting back against the greed of the pharmaceutical industry,” he continued.

Mr. Manchin was one of four senators to oppose Dr. Califf’s nomination during the Obama administration. Still, he was confirmed in an 89-4 vote.

In choosing Dr. Califf, the president bypassed acting Commissioner Janet Woodcock. Although she was under consideration for the role, she fell out of contention after it was clear that several senators would not support her nomination because of what they said was the FDA’s lax approval policy toward opioids when she ran the agency’s drug division.

The White House had been criticized for the slow pace of the search for a new FDA director, taking up most of Mr. Biden’s first year.

The FDA had been without a permanent leader for more than eight months during an unprecedented coronavirus pandemic, a lapse that brought increased scrutiny to its decisions.

Mr. Biden was staring down a Monday deadline to either nominate Dr. Woodcock or pick another leader for the agency, which approves and regulates vaccines, medical devices and other therapies.

Dr. Califf served as FDA commissioner for roughly a year in the waning days of the Obama administration. He also spent two years as the deputy commissioner of the FDA’s medical products and tobacco office.

He came under fire as FDA commissioner for his role overseeing the agency’s approval of a drug to treat Duchenne, a rare form of muscular dystrophy. Some questioned the efficacy of the medicine, but Dr. Califf went against the FDA’s independent advisory group that recommended against its approval.