Senate

Manchin opposes Biden FDA nominee

Sen. Joe Manchin (D-W.Va.) said Friday that he opposes President Biden’s nominee for Food and Drug Administration (FDA) commissioner, Robert Califf, arguing he is not strong enough in fighting the opioid epidemic given his ties to the pharmaceutical industry. 

“Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward,” Manchin said in a statement. “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 added.

Manchin was one of four senators to oppose Califf when President Obama nominated him in 2016 as well.

That vote ended up being 89 to 4, so Republican support could help Califf this time as well.

Califf, a cardiologist, has received pharmaceutical industry funding for his research at Duke University and has also consulted for pharmaceutical companies.

While it is possible Manchin’s vote would not be needed to confirm Califf, it is still a sharp rebuke of the Biden administration from Senate Democrats’ main swing vote on a range of issues.

Sen. Maggie Hassan (D-N.H.), who faces reelection next year in a state also hit hard by the opioid epidemic, stopped short of opposing Califf’s nomination but expressed concerns about the FDA’s handling of opioids and said the next commissioner must act “independently from the pharmaceutical industry.”

“I have been deeply troubled by some of the FDA’s past decisions — especially as it relates to the approving and labeling of opioid-based medications — and the FDA has yet to make clear what it is doing to learn from its actions,” she said in a statement. “I will thoroughly review Dr. Califf’s record as we consider his nomination in the Senate.”

Still, as evidenced by the overwhelming vote in 2016, many other Democrats might not have the same level of concern.

House Energy and Commerce Committee Chairman Frank Pallone (D-N.J.) praised Califf on Friday.

“Dr. Califf is a proven leader who will bring a wealth of knowledge and expertise upon his return to the agency,” Pallone said.

“During his first tenure as Commissioner, Dr. Califf led FDA with distinction and played a key role in helping Congress shape and pass the 21st Century Cures Act,” he added, referring to legislation to increase medical research funding and streamline certain FDA approvals of new drugs.

Biden noted in a statement on Friday making the announcement that Califf “had strong bipartisan support in the Senate in 2016.”

“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,” Biden said. “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.”

Updated at 12:19 p.m.