The US Food and Drug Administration (FDA) has confirmed the appointment of Robert Califf as its 22nd commissioner, following a US Senate vote of 88 to 4 in his favour.
Califf was nominated to replace previous commissioner, Margeret A Hamburg, by US President Barack Obama in September 2015. This appointment follows his role as Deputy Commissioner of the FDA Office of Medical Products and Tobacco, a position he has held since January 2015.
Stephen Ostroff, acting FDA commissioner, says, “Today the US Senate voted in support of the confirmation of Robert Califf to be Commissioner of US Food and Drug Administration. 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, across the many areas we regulate—and I am confident that our public health and scientific contributions will further grow under his exceptional leadership.”
The American College of Cardiology (ACC) issued support for the appointment of the cardiologist and clinical researcher. Kim Allan Williams, ACC president, says that Califf is “the right person to lead the FDA”.
Califf’s appointment has also been endorsed by the New England Journal of Medicine as well as by the American Heart Association. US senator Patty Murray, a ranking member of the Health, Education, Labor & Pensions (HELP) committee, praised a leadership approach which “puts patients and families first and upholds the highest standards of patient and consumer safety.”
However, concerns surrounding Califf’s percieved industry ties have been expressed by senator and US presidential candidate Bernie Sanders.
Edward Markey, a US senator who was one of eight to sign a letter protesting the FDA’s recent approval of oxycodone for paediatric use without the prior consultation of an advisory expert panel, has expressed concerns that Califf will not appropriately act on growing opioid abuse in the USA. After speaking with Califf about these concerns, Markey reported in a December 2015 letter to Sylvia Mathews Burwell, secretary of Health and Human Services, that Califf, “did not give me confidence that under his stewardship the FDA would confront the highly problematic manner in which the agency is approaching these issues.” In a post-cloture debate prior to the senates’ vote, Markey claimed that Califf will likely not become an advocate for the changes required to tackle these issues.