Big plans and big problems for new FDA Chief

On February 24, the U.S. Senate voted to confirm Robert Califf, MD, as the new Food and Drug Administration (FDA) commissioner. The Senate vote in Califf’s favor was 89-4, ending a yearlong debate over his suitability.

Califf, a former medical researcher at Duke University, was nominated for the position by President Obama in January 2015. Despite having widespread support from many patient advocacy groups, academics, and medical societies, Califf’s confirmation had been delayed by a small group of senators, including presidential candidate Bernie Sanders. The senators said they were concerned about how Califf’s links to the pharmaceutical industry would affect his response to the prescription opioid epidemic.

The FDA is facing many challenges, including the rapid rise in opioid addictions, changing the medical device review process, and a backlog of 4,300 generic drugs still waiting approval. Now confirmed, Califf says his priorities are to:

•    Adopt a two-tier system of limited, focused clinical drug trials to streamline the process. Califf says he hopes to get new medicines to Americans quicker and cheaper while still maintaining high safety standards.
•    Improve surveillance systems to monitor medical device safety.
•    Attract and retain more leading scientists to the FDA.
•    Gain the authority to regulate e-cigarettes.