The White House has decided to nominate Robert Califf to take the reins of the regulatory agency once again.
The White House finally decided to nominate Robert Califf to once again take the reins of this complex and vital regulatory agency, acknowledging the difficulty of finding an experienced and capable administrator without visible industry ties. Califf’s appointment has been discussed and analyzed for months and now moves forward at the last moment. Under federal rules, acting commissioner Janet Woodcock has to leave that position by Nov. 15. Now, however, she can remain in place during the Senate confirmation process for Califf, which could take some time in the face of a very packed year-end schedule for Congress. Although many policy makers and medical leaders backed Woodcock for the top job, she ran into opposition from some legislators and consumer groups that considered her too close to industry and blamed her for authorizing market approval of opioid pain killers, later found to fuel addiction and deaths. Califf had a brief stint as FDA commissioner in the waning months of the Obama administration, taking the helm following the departure of Margaret Hamburg from the top spot in 2015. His confirmation at that time met only minor opposition in the Senate and was supported by then majority leader Mitch McConnell. Most research advocates consider Califf’s long experience in overseeing clinical trials a plus, while public health groups applaud his strong opposition to tobacco use. Califf has extensive academic credentials, as well valuable experience as a consultant to drug developers and most recently as top official at health tech firms, Verily Life Sciences. His appointment by President Biden ends months of uncertainty about the future path for the high-profile agency. FDA has played a central role in orchestrating the development of vital anti-COVID vaccines and therapies, along with facilitating supplies of critical diagnostics and medical equipment, and the new commissioner may face the early challenge of vetting and approving important new therapeutics to combat the virus.