The Senate narrowly approved President Joe Biden's nomination to head the Food and Drug Administration. This was despite a tangle of political controversies that threatened what was initially thought to be an easy confirmation.
Dr. Robert Califf is a prominent medical researcher and cardiologist who will once again head the agency. He was briefly the director of the agency during President Barack Obama's tenure.
Despite playing a key role in the Covid-19 response effort and reviewing vaccines, drugs, and tests, the FDA has not had a permanent leader for more than a decade.
This narrow vote demonstrates the political polarization surrounding the health care issues FDA monitors. It contrasts with the overwhelming support Califf received six years ago. The Senate had previously confirmed him to the position by a vote 89-4.
Califf inherits a series of reviews and decisions at the agency that regulates multibillion-dollar industries like prescription and over-the counter drugs, medical devices, and tobacco products.
To-do lists of Califf include specific promises he made to Senate legislators in order to secure the job. He has pledged to launch a thorough review of opioid painkillers such as OxyContin that will be completed quickly. This was after they were approved by the FDA in the 1990s.
Senator Joe Manchin (D-W.Va.) urged senators Monday to oppose Califf, saying that he is responsible for many of the drug deaths that occurred since his tenure as FDA commissioner. Califf issued new warning labels for opioids during his 11-month tenure and received outside recommendations about how to tighten drug regulation. However, he was fired by President Donald Trump prior to implementing any significant changes.
"Nothing Dr. Califf said or done has led to me to believe that he will operate FDA any different than he did during the previous tenure," stated Manchin, whose state has been devastated by opioid addiction for decades and overdoses.
Given his strong support by pharmaceutical companies and patient groups, the White House assumed that enough Republicans would support Califf in order to overcome any Democratic defections.
Anti-abortion activists launched a campaign against his Senate vote. They were outraged at a recent FDA decision which made it easier to access abortion pills. Several groups, including the Susan B. Anthony List, threatened to withdraw support from Republican senators who support Califf.
The FDA faces several key decisions more than a year after it approved the first Covid-19 vaccines. These include whether to allow their expansion to children under 5. The FDA delayed reviewing Pfizer’s vaccine last week.
FDA commissioners don't usually participate in scientific reviews but they act as a liaison between the White House and scientists. This relationship has been strained in the last year, as Biden's coronavirus Covid-19 taskforce has repeatedly outperformed the FDA's scientific reviews.
Califf will also have to replace the FDA's tobacco centre head, who is currently weighing whether to ban Juul, Reynolds American, and other vaping companies based on teens' use. Mitch Zeller is the long-serving director of FDA tobacco. He will be retiring this spring.
The FDA is also drafting new regulations to ban menthol cigarettes . This has been a long-cherished goal for many Democratic legislators and public health advocates.
Califf has publicly defended the potential to save hundreds and thousands of lives by accepting FDA's authority ban certain tobacco products. Although the FDA has these powers for over a decade, industry lawsuits have hampered its attempts to regulate traditional and e-cigarettes.
After more than 35 years of service at Duke University, Califf came to the FDA for the first time. He founded a contract research agency that conducted studies for some of the largest drugmakers in the world.
He has been a Google health policy advisor and a board director for more than half a dozen biotech and drug companies since he left government. According to his ethics disclosures form, Califf agreed that he would resign from all positions and invest several million dollars in FDA-regulated businesses.