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Biden Set To Pick Robert Califf As FDA Commissioner, Bringing Back Obama-Era Chief

Updated Nov 12, 2021, 01:45pm EST

Topline

President Joe Biden nominated Robert Califf, the former Food and Drug Administration commissioner during the Obama administration, to again lead the FDA Friday after the agency near the center of the government’s Covid-19 response has been without a permanent leader for months.

Key Facts

Biden said in a statement Califf has the experience and expertise to lead the agency through the coronavirus pandemic, adding that it is “mission critical that we have a steady, independent hand to guide the FDA.”

Califf, a cardiologist and clinical trial specialist, served as FDA commissioner for the last 11 months of former President Barack Obama’s term.

If confirmed by the Senate, Califf would oversee decisions at the agency including those related to Covid-19 vaccines, electronic cigarettes and prescription drugs.

Califf would be the first FDA commissioner to return for a second tour since the 1940s, according to the Associated Press.

The White House had a legal deadline of mid-November to find a permanent commissioner, which has been filled on an interim basis since January.

Key Background

Califf received broad support during confirmation for his first stint as FDA commissioner, winning by an 89-4 margin. Califf began working at the FDA in 2015, and his 11-month term was highly influenced by revelations about pharmaceutical companies, including the opioid epidemic, the AP reports. He was one of the first FDA officials to acknowledge the agency’s missteps in oversight and regulation of prescription painkillers, calling for a sweeping review in 2016. “If addiction to opioids and misuse of opioids is an enemy then we at the FDA — like every other part of society — underestimated the tenacity of the enemy,” Califf told the AP in 2016. “So we’ve got to adjust.”

Chief Critic

Sen. Joe Manchin (D-W.Va.) opposed Califf’s nomination in 2016, and immediately said he would oppose his new nomination after it was announced Friday. He claimed changing the culture at the FDA is crucial to combating the opioid epidemic, and that Califf’s ties to the pharmaceutical industry “will take us backwards not forward.” “His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction,” Manchin said in a statement, urging the Biden administration to choose a new nominee. Sen. Maggie Hassan (D-N.H.) also said in a statement she will “throughly review” Califf’s record following past decisions by the FDA, specifically on the approval and labeling of opioid medications.

What To Watch For

Califf may face more scrutiny from Democrats this time around during confirmation, Politico notes, as he has served as a policy advisor for Google’s parent company, Alphabet, since 2019, in addition to working for the Duke Clinical Research Institute.

Tangent

Dr. Janet Woodcock, the FDA’s drug director, has served as acting commissioner since January. She was expected to receive the nomination for the permanent position, but Democratic lawmakers took issue with the handling of opioid prescription painkillers during her 30-year tenure with the FDA, as well as the recent decision to approve a controversial Alzheimer’s drug, according to CNN.

Further Reading

Biden poised to nominate Califf as FDA chief (Politico)

FDA Commissioner Calls For Inspector General Probe Into Biogen Alzheimer’s Drug Approval (Forbes)

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