The US Senate has confirmed Dr Robert Califf's appointment to be the new FDA commissioner, replacing Margaret Hamburg who resigned last March.
A cardiologist and medical researcher, Dr Califf joined the FDA in January 2015 as deputy commissioner for medical products and tobacco and was nominated for the commissioner role by President Barack Obama shortly after Hamburg announced her departure.
The FDA's acting commissioner of food and drugs Stephen Ostroff said: “Dr Califf has demonstrated a long and deep commitment to advancing the public health throughout his distinguished career as a physician, researcher and leader in the fields of science and medicine.
“He understands well the critical role that the FDA plays in responding to the changes in our society while protecting and promoting the health of the public.”
But Dr Califf faced a harder than expected confirmation hearing, which politicians used as an opportunity to quiz the FDA on its record on opioid painkillers.
Fatal overdoses from prescription opioid painkillers have quadrupled since the late 1990s, with some arguing the regulator had approved too many of the drugs, with too few safeguards on their use.
Prior to joining the FDA in January 2015 Dr Califf was vice chancellor of clinical and translational research at Duke University in North Carolina in the US. His previous roles at Duke include director of the Duke Translational Medicine Institute (DTMI) and professor of medicine in the Division of Cardiology. He was also founding director of the Duke Clinical Research Institute.
His time at the Institute, a contract research organisation, also brought criticism of Dr Califf from some quarters due the links it has with the pharmaceutical industry.