President Biden nominated Dr. Robert Califf to head the Food and Drug Administration Friday, returning him to the role he held during the final 11 months of the Obama administration.
In a statement, the president said Califf “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.
“As the FDA considers many consequential decisions around vaccine approvals and more, it is mission-critical that we have a steady, independent hand to guide the FDA,” Biden added. “I am confident Dr. Califf will ensure that the FDA continues its science and data drive [sic] decision-making.”
Biden announced Califf’s nomination three days ahead of the deadline to pick a replacement for Acting FDA Commissioner Janet Woodcock, who has run the agency since the president took office.
Califf, a longtime cardiology professor at Duke University, has drawn scrutiny over his past ties to the pharmaceutical industry.
Sen. Joe Manchin (D-WV) blasted Califf’s nomination as an “insult to the many families and individuals who have had their lives changed forever” by opioid addiction.
“I could not support Dr. Califf’s nomination in 2016 and I cannot support it now,” Manchin said.
“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 added. “Championing the needs of your nation’s public health must be their number one priority.”
Califf was appointed deputy commissioner of the FDA’s medical products and tobacco office in 2015. The following year, he was nominated to replace Margaret Hamburg as FDA commissioner and was confirmed by the Senate 89-4.
White House press secretary Jen Psaki expressed confidence Friday that Califf would be confirmed by the Senate despite Manchin’s opposition.
“He was confirmed by a vote of 89 to 4,” she said. “One of those four is the individual you mentioned [Manchin] and every senator can vote for [or] against members or people who are nominated. That’s their role, but we feel he’s a qualified person who has the exact experience for this moment.”
The FDA has been criticized for not acting fast enough to approve potentially life-saving vaccines and treatments for COVID-19, which has caused the deaths of more than 759,000 Americans since March 2020.
The FDA has overseen the approval process for several vaccines, but only one — Pfizer — has received the official OK. In October, the FDA also approved the COVID-19 vaccine for children ages 5 to 11.