He founded the Duke University Clinical Research Institute in 2006 and served as its director.
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Califf-a Duke University researcher, professor and cardiologist-joined the FDA as deputy commissioner for medical products and tobacco in January. He also led the university’s efforts on translational research, or turning basic scientific discoveries into new treatments for patients. Its authority extends from drugs and food to medical devices and tobacco.
If approved, he will take up his post as the FDA prepares to implement what could be a slew of changes sparked by a U.S. House of Representatives bill designed to speed new drugs to the market.
While aspirants to the post must receive a confirmation from the U.S. Senate, experts believe that Califf will not face any serious opposition because of his distinguished career in the academe, with most of his achievements coinciding with his tenure in Duke.
“The Administration’s commitment to stable leadership at FDA will help the Agency keep pace with the rapidly evolving science of drug development, and recruit and retain world-class scientists and medical reviewers”.
Califf is “a soft-spoken Southerner with a passion for improving clinical trials”, and extensive knowledge of industry, Nature’s Heidi Ledford reported earlier this year.
The FDA said Dr. Califf, 63 years old, wasn’t immediately available for interviews.
As commissioner, Dr. Califf would have to deal with a number of hard questions on some of the biggest public health issues of the day, including the opioid painkiller abuse epidemic, obesity and the rise of electronic cigarettes. Xarelto generated $1.52 billion in sales a year ago , according to data compiled by Bloomberg.
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If confirmed, Califf will replace Stephen Ostroff, who has served as acting commissioner since former commissioner Margaret Hamburg left the position in March.
