Former FDA Commissioner Califf is finalist to repeat role
Back to the Future
It appears that the Biden administration is closing in on former Food and Drug Administration (FDA) commissioner Robert M. Califf, M.D., to serve again as agency chief, according to five undisclosed sources, reported Tyler Pager, Dan Diamond and Yasmeen Abutaleb of the Washington Post. Dr. Califf, a cardiologist, currently serves as a professor of cardiology at Duke University School of Medicine.
The FDA, which has been run by acting commissioner Janet Woodcock, has not had a permanent leader for more than eight months. During that time, the agency has faced great scrutiny because of the COVID-19 pandemic. Federal law requires President Joseph Biden to either nominate Woodcock or pick an alternate leader for the FDA -- which plays a central role in regulating vaccines, therapies and other medical products – by mid-November.
This is a critical time for the FDA, which is deciding whether to authorize coronavirus vaccines for young children, more booster shots for adults and additional treatments to fight the pandemic. It is also reviewing possible bans on Juul and other e-cigarette manufacturers and facing a probe into its approval of a controversial Alzheimer’s drug.
Dr. Califf served as FDA commissioner for less than a year at the end of Barack Obama’s administration, after being confirmed in an 89-4 vote in February 2016. Sens. Joe Manchin III (D-W.Va.), Bernie Sanders (I-Vt.) and other senators who criticized the longtime Duke University researcher’s ties to pharmaceutical companies that helped fund his work and paid him significant consulting fees. He had also served as deputy commissioner of the FDA’s Office of Medical Products and Tobacco.
Dr. Califf has advised Google and its spinoff, Verily Life Sciences, since leaving the Obama administration, and has focused on fighting chronic disease. He urged the Biden administration to take more action on the global vaccine response this summer, saying that the long-lasting effects of coronavirus will likely plague the U.S. health system for years to come. As he wrote in the journal of the American Heart Association in April 2021, “[O]nce the acute phase of this crisis has passed, we will face an enormous wave of death and disability as a result of common chronic diseases.”
Although Pres. Biden had appointed other senior health care officials quickly, bipartisan lawmakers and public health experts have been unhappy about the delays in selecting a full-time FDA commissioner. Some agency officials are happy with Woodcock’s leadership and hoped she would continue. They praised her “steady hand at a tumultuous time,” but Manchin criticized Woodcock’s handling of opioids and other regulatory decisions. Some FDA staff members disagreed with Woodcock for signing onto a statement supporting coronavirus booster shots before FDA’s own vaccine specialists had vetted the plan. The White House has thought about retaining Woodcock in a senior role.
Administration officials had hoped to find a candidate who reflected Biden’s pledge of a diverse leadership team. They looked into several women and people of color but decided that Dr. Califf is “a government veteran who knows and understands the FDA.” Numerous health eperts around the country have weighed in on a positive note about Dr. Califf.