Obama nominates FDA's No. 2 official to lead agency

WASHINGTON - President Obama has nominated the Food and Drug Administration's second-highest ranking official, Robert Califf, to lead the agency, which regulates consumer products ranging from medications to seafood to cigarettes.

The White House made the announcement late Tuesday in a statement naming officials nominated for various federal posts. If confirmed by the Senate, Califf would take the reins at a critical juncture for the agency, which is under pressure from Congress to streamline regulations for medical products.

Califf, 63, joined the FDA as deputy commissioner in March after more than 30 years as a prominent cardiologist and medical researcher at Duke University. He is among the most cited medical authors in academia, with more than 1,200 journal articles.

His nomination to head the agency was widely expected after former Commissioner Margaret Hamburg announced she would step down just days after appointing Califf to the role of deputy commissioner. He currently oversees the FDA's centers for drugs, devices, and tobacco products.

Califf will succeed Stephen Ostroff, who has been acting commissioner since Hamburg resigned. Ostroff - most recently the agency's chief scientist - arrived at the FDA two years ago from the Pennsylvania Department of Health.

The 1981 graduate of the University of Pennsylvania School of Medicine has accumulated interim titles over the years. In Harrisburg, he was acting physician general (in addition to director of the Bureau of Epidemiology). Before that, Ostroff was acting director of the Select Agent Program at the Centers for Disease Control and Prevention (in addition to being deputy director of CDC's National Center for Infectious Diseases).

And while Ostroff didn't get much public attention in Harrisburg, the current (non-acting) chief doctor has attracted plenty: Physician General Rachel Levine is one of the few openly transgender public officials in the United States.

Califf, Obama's nominee, has spent most of his career in academia but is deeply versed in FDA issues, especially the clinical testing of drugs and medical devices. He served on expert committees that advise the FDA and was considered for the commissioner's job at least twice before - once under President George W. Bush and once earlier in the Obama administration.

"Dr. Califf has had a long and distinguished research career, and is internationally known for his expertise in clinical trials," said Aaron Kesselheim of Harvard Medical School. "He's thoughtful and personable, and I'm sure will be a strong advocate on behalf of the FDA during a very critical period."

The FDA's commissioner is subject to pressure from an array of outside interests, including corporations, politicians, consumer advocates and medical professionals. Most modern FDA commissioners have stayed on the job for less than three years.