Obama Taps FDA Deputy Commissioner To Lead Agency

Dr. Robert Califf, former vice chancellor for clinical and translational research, was appointed deputy commissioner for Medical Products and Tobacco at the FDA in January and will now await Senate approval for the commissioner position after being nominated.

In 2006, Califf founded the Duke University Clinical Research Institute, a contract research group that has conducted studies for virtually all of the world’s largest drugmakers.

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

The designation stays subject to acknowledgment by the US Senate, however industry spectators suspect that there won’t be an excessive amount of imperviousness to the move.

Former FDA Commissioner Margaret Hamburg stepped down at the end of March following a six-year stint at the helm, and Stephen Ostroff has served as acting commissioner since.

Francis Collins, director of the National Institutes of Health and a scientist who has worked with Dr. Califf for years, called this “a fantastic nomination”.

President Obama announced he has chosen a new Food and Drug Administration commissioner with deep industry ties.

In addition to his academic background, Califf’s ties to industry have always been close.

As head of the FDA, Califf would inherit a raft of projects and potential challenges, including unfinished tobacco regulations, food safety and labeling reforms and proposals from Republican lawmakers focused on streamlining drug reviews. Senior officials of the FDA said they’re uncertain what direction he may take the agency, but said one issue important to him is an effort to create more openness regarding data from clinical trials. The 21st Century Cures Act, approved by the House, calls for other ways to speed drug approvals.