FDA Gets New Leader as Senate Confirms Nominee Califf

  • Senate votes 89-4 in favor of Obama's pick to head agency
  • Califf was director of Duke's Clinical Research Institute

The U.S. Senate confirmed President Barack Obama’s nominee Robert Califf to lead the Food and Drug Administration, promoting the former Duke University researcher from serving as a deputy at the agency to the top spot.

The Senate voted 89-4 on Wednesday in favor of Califf, who was appointed deputy FDA commissioner for medical products and tobacco in January 2015. Before that, he was the founding director of Duke’s Clinical Research Institute, the world’s largest academic research organization.

Califf takes over at a time when the FDA has been criticized by some members of Congress for being too slow to approve needed therapies. Califf disagrees, and said approvals may have gotten as fast as they can.

“We’re faster than Europe, and first-to-market is dominantly a U.S. phenomenon,” he said in a telephone interview. “I don’t think timing is the place to focus right now.”

Instead, the science and quality of new-product submissions to the agency could be improved to speed up the development process, he said.

E-Cigarette Regulation

The agency also has some high-profile regulatory actions coming up, including extending its current oversight of tobacco to include electronic cigarettes. More than six years after Congress gave the FDA authority over tobacco, the regulation on e-cigarettes is overdue, and Califf said it could come out any day.

“I’m a cardiologist,” he said. “I’ve seen a lot of people die. I’m highly motivated to reduce the harm from tobacco.”

He acknowledged that the issue is complicated. “There’s a lot at stake. Things like the e-cigarette industry didn’t exist when the tobacco act was passed.”

Califf also will lead the agency as it works to modernize safety rules meant to curtail food-borne illnesses.

On the pharmaceutical side, the FDA is working to approve generic drugs more quickly, as well as figuring out the details of regulating a new class of drugs called biosimilars, which are less expensive versions of biologic drugs.

Obama nominated Califf for the position in September after Margaret Hamburg stepped down in March 2015. Stephen Ostroff, the agency’s chief scientist, has served as acting commissioner in the interim.

Opioid Abuse

Some senators opposed Califf’s nomination, saying the FDA hasn’t done enough to curb the opioid abuse epidemic in the U.S. Close to 20,000 Americans died in 2014 from overdoses on opioid prescription painkillers, which include drugs like OxyContin, according to the National Institutes of Health. 

The opioid issue is one of his top priorities, Califf said. The FDA has said it will work to address the concerns and has set up meetings to discuss pain management and abuse potential. It will also convene outside experts to advise staff every time it’s considering an application for an opioid not made with abuse deterrent technology.

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