Robert M. Califf, M.D., won confirmation by the U.S. Senate this morning to become the FDA commissioner, a decision that set aside objections raised by some senators over the agency’s response to the opioid epidemic and his ties to biopharmaceutical companies.
Dr. Califf, now deputy FDA commissioner for medical products and tobacco, won approval by an 89-to-4 vote. Voting against his confirmation were Sens. Kelly Ayotte (R-NH), Richard Blumenthal (D-CT), Joe Manchin (D-WV), and Ed Markey (D-MA).
Sens. Bill Nelson (D-FL) and Rob Portman (R-OH) voted to confirm Dr. Califf—two days after they sided against advancing the nomination to the full senate in a procedural vote.
Dr. Califf was nominated in September by President Obama to succeed Margaret A. Hamburg, M.D., as head of the agency. Dr. Califf joined the FDA after 33 years with Duke University School of Medicine and the Duke University Medical Center, most notably as its vice chancellor of clinical and translational research and, in 2006, founder of the Duke University Clinical Research Institute.
In recent months, Dr. Califf has identified priorities for the FDA that include:
- Advancing translational medicine while balancing its desire to promote innovation with its need to protect public health.
- Advancing greater use of data by helping professionals generate more and better evidence to base sounder decisions, while retaining the agency’s role as an independent evaluator of treatments and technologies.
- Carrying out the agency’s portion of President Obama’s precision medicine initiative by working with the NIH and the research community to develop a new approach to evaluating next-generation sequencing tests.
Soon after Dr. Califf was nominated, Sen. Bernie Sanders (D-VT)—now seeking the Democratic party’s presidential nomination—criticized the nomination, arguing that Dr. Califf would not do enough to contain drug prices. Sanders’ stance emerged two weeks after his rival Hillary Rodham Clinton unveiled a series of proposals aimed at cutting drug prices.
Sanders and some other senators also criticized Dr. Califf for what they termed an inadequate agency response to the rapid rise in opioid abuse, as well as for accepting consulting fees from biopharma giants that funded research carried out at Duke.
The FDA earlier this month began a reassessment of its approach to opioid medications, saying it will develop an action plan with policies aimed at reversing the epidemic of abuse while still providing patients in pain access to effective relief.
As for industry funding, Dr. Califf told Time last year that he estimated such fees accounted for less than half his annual income, and that collaboration among industry, academia, and government was essential to drug discovery. Sanders missed this morning’s vote, but later issued a statement expressing disappointment with Dr. Califf’s confirmation.
At Duke, Dr. Califf led several key clinical trials, including the pivotal ROCKET AF study that led to FDA approval of Jansen Pharmaceuticals’ Xarelto® (rivaroxaban) in 2011. With more than 1,200 publications in peer-reviewed journals to his credit, he has been recognized by the Institute for Scientific Information as one of the 10 most-cited medical authors.
“We are confident Dr. Califf will serve in the public’s best interest as the FDA moves forward to address opioid abuse, harness new and innovative technologies to inform its decision making, monitor the safety of products developed both in and outside our borders, and strengthen the agency’s workforce and infrastructure,” Mary Woolley, president and CEO of the research advocacy group Research!America, said in a statement.
Sara Radcliffe, president and CEO of the California Life Sciences Association, added: “We believe Dr. Califf will be an exemplary steward of the FDA’s public health and safety mission, and will continue to improve the agency’s drug and device approval processes to ensure that patients receive the safest and most effective treatments as quickly as possible.”