FDA
(IN PHOTO)The headquarters of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly. REUTERS

The Biden administration has announced its nomination of Robert Califf to lead the Food and Drug Administration (FDA) after almost a year under an acting administrator.

A former FDA head himself under the Obama administration, Califf brings both experience at the agency and concern for his post-government work in the private sector. But his nomination already faces opposition from within the Democratic Party.

"Dr. Robert Califf is one of the most experienced clinical trialists in the country, anddd has the experience and expertise and to lead the Food and Drug Administration during a critical time in our nation's fight to put an end to the coronavirus pandemic," read a statement from President Joe Biden, endorsing his pick.

Califf previously worked at the agency as a deputy administrator deputy commissioner of the FDA's medical products and tobacco office under former President Barack Obama. In this role, he gained direct experience working together with then-Vice President Joe Biden on the Cancer Moonshot Initiative.

Califf’s confirmation would put a permanent leader at the FDA at a time when the fight against COVID-19 continues. Outgoing acting administrator Janet Woodcock has shepherded the FDA since January and under her tenure, the agency fully authorized three COVID-19 vaccines, the launch of a nationwide booster shot campaign, and a constant campaign of reassuring the public of the benefits of vaccinations.

However, by serving only in an acting capacity, Woodcock lacked the weight to set FDA priorities or the influence in interagency or internal disagreements compared to confirmed counterparts like CDC Director Rochelle Walensky.

For all the experience Califf brings back to the FDA, his nomination is already promising to challenge the Biden administration. Shortly after his nomination was reported, Sen. Joe Manchin, D-W.Va., released a statement opposing his candidacy over his ties to the pharmaceutical industry. He described Califf’s nomination as an “insult” to the families of those who lost a loved one to opioid abuse.

“I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic. Instead, Dr. Califf's nomination and his significant ties to the pharmaceutical industry take us backwards not forward," said Manchin.

Manchin’s opposition is not new. In 2016, he opposed Califf when President Obama nominated him to the FDA and he was joined by Sen. Bernie Sanders, I-Vt., within the Democratic caucus in opposition.

Manchin was joined in his opposition by Sen. Richard Blumenthal, D-Conn., who told Politico that he too had "grave reservations" about Califf but did not say he would vote against him.

After leaving government service, Califf worked with Google's parent company Alphabet. Before joining the FDA in 2015, ProPublica reported that Califf served as a consultant for a number of drug makers, including Johnson & Johnson, Merck, and AstraZeneca.

Given Democrats’ razor thin margin in the Senate, Manchin's opposition together with possible other dissenters in the party would necessitate support from Republican senators. This may not be an issue for Califf, who secured an 89-4 confirmation when he was first nominated in 2016.