Source: Bloomberg
by Anna Edney, Justin Sink, Angela Greiling Keane
September 15, 2015
The Obama administration made the announcement Tuesday in a statement listing nominees for several key administration posts. Since January, Califf has been deputy FDA commissioner for medical products and tobacco. Before that, he was founding director of Duke’s Clinical Research Institute, the world’s largest academic research organization, the FDA said. He also led the university’s efforts on translational research, or turning basic scientific discoveries into new treatments for patients.
Califf’s nomination is subject to Senate confirmation.
Califf inherits an agency that is in the middle of overhauling how it handles food safety to help companies and consumers avoid foodborne illnesses and is expected soon to extend its oversight of tobacco to electronic cigarettes. The agency also is figuring out the details of regulating a new type of drug called biosimilars, which are less expensive copies of biologic drugs.
“His transformative leadership at Duke, and real-world experience with patients make him a remarkable choice that will bring important new perspectives to an already strong agency,” Ellen Sigal, chairwoman of Friends of Cancer Research, said in a statement. The advocacy organization works closely with the FDA and other health agencies to help shape policy.
When Califf was appointed deputy commissioner, it was widely assumed he would be the nominee to permanently replace Hamburg. Califf’s job as a researcher and professor at Duke has been on hold since he joined the FDA.
Califf is held in high esteem in the medical world — he has more than 1,200 publications in peer-reviewed literature, according to the FDA — and also has worked closely with the drug
industry. He led the key clinical trial evaluating Johnson & Johnson’s blood-thinner Xarelto, which the FDA approved in 2011 to prevent strokes in people with an irregular heartbeat. Xarelto generated $1.52 billion in sales last year, according to data compiled by Bloomberg.
Former FDA Commissioner Margaret Hamburg stepped down at the end of March and Stephen Ostroff, the agency’s former chief scientist, has served as acting commissioner since.
