New FDA Commissioner Confirmed

3 min

On Wednesday, February 24, 2016, the U.S. Senate voted 89-4 to confirm President Obama's nominee for the U.S. Food and Drug Administration (FDA) Commissioner, Robert M. Califf, M.D. Dr. Califf was nominated by President Obama in September to succeed Margaret Hamburg. The four Senators voting against were Sen. Kelly Ayotte (R-NH), Sen. Richard Blumenthal (D-CT), Sen. Ed Markey (D-MA), and Sen. Joe Manchin (D-WV).

About Dr. Califf

Dr. Califf attended Duke University for both his undergraduate degree and medical school. After graduating from medical school, Dr. Califf completed an internship and residency in internal medicine at University of California, San Francisco, followed by a cardiology fellowship at Duke. He subsequently served as the Donald F. Fortin, M.D., Professor of Cardiology, Vice Chancellor for Clinical and Translational Research, and founding director of the Duke Clinical Research Institute. In his time at Duke, Dr. Califf engaged in extensive clinical investigations, and he has been cited as an author in more than 1,200 peer-reviewed publications. Dr. Califf also co-chaired the Clinical Trials Transformation Initiative, which is a public-private partnership co-founded by Duke and the FDA to develop strategies for improving the quality and efficiency of clinical trials.

In February 2015, he was appointed to the position of Deputy Commissioner for Medical Products and Tobacco for the FDA. As Deputy Commissioner for Medical Products and Tobacco, Dr. Califf provided executive leadership for the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Tobacco Products. In addition, he also oversaw the Office of Special Medical Programs, providing direction for cross-cutting clinical, scientific, and regulatory initiatives, including precision medicine, combination products, orphan drugs, pediatric therapeutics, and the advisory committee system.

More information about Dr. Califf can now be found on the FDA's website, Commissioner's Page.

Reaction to the Appointment and Confirmation

Despite the overwhelming vote in favor of confirmation, Dr. Califf's confirmation is not without controversy. Minority Leader Sen. Harry Reid (D-NV) expressed support for Dr. Califf on the Senate floor, stating: "[Dr. Califf]'s a fine man. He'll do a good job as head of the Food and Drug Administration." However, Sen. Bernie Sanders (D-VT) has publicly opposed Dr. Califf's nomination on the grounds that he does not believe that Dr. Califf would be able to stand up to the pharmaceutical industry. Others criticizing Dr. Califf's appointment cited his ties to the pharmaceutical industry, both his co-writing scientific papers with pharmaceutical company researchers and financial ties to drug companies, including consulting fees and support of his university salary. Supporters dismiss industry financial ties as not unusual in academic medicine.

Please feel free to contact us with any questions you have about the new Commissioner.