Posted 24 February 2016
By Michael Mezher
The US Senate on Tuesday voted 89 to 4 to confirm Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA).
Califf's path to confirmation was made clear after a procedural vote Monday evening, when senators voted 80 to 6 to move the nomination to a vote.
In September, President Barack Obama nominated Califf to replace Margaret Hamburg, who resigned in March after leading FDA for six years and was replaced in the interim by Stephen Ostroff.
Califf, a cardiologist, joined the agency as deputy commissioner for medical products and tobacco in February 2015 after heading the clinical and translational research program at Duke University and helping to found the Duke Clinical Research Institute.
Department of Health and Human Services Secretary Sylvia Burwell congratulated Califf, saying he is "the right person with the right experience to build on the FDA's unsurpassed record of protecting public health while encouraging innovation and the introduction of new life-saving therapies to the market."
Other organizations, including the Pharmaceutical Research and Manufacturers of America, Biotechnology Innovation Organization, the American Health Association, the National Organization for Rare Disorders, National Health Council and California Life Sciences Association have also issued statements in support of Califf's nomination.
Just one day before the HELP committee voted unanimously to move Califf's nomination to the full Senate last month, Califf responded to questions raised by Sen. Alexander about his ability to lead the agency.
In a letter to the senator, Califf vowed to uphold FDA's standards and spelled out his top three priorities for reforming the agency, which include clinical trial reform, improving communication between FDA and the scientific community and increasing collaboration with other federal agencies such as the National Institutes of Health.
Controversies Ahead of Confirmation
While Califf was widely supported to head the FDA, several controversies threatened to block or stall his confirmation.
In January, Focus reported that the European Medicines Agency (EMA) was investigating a Phase III trial led and designed by Califf for the atrial fibrillation drug Xarelto. The trial, known as ROCKET-AF, relied on an International Normalized Ratio (IRN) device which was later found to give falsely low results.
However, after reexamining the study data, EMA announced that the faulty device did not impact the "overall safety or benefit-risk balance of Xarelto."
On Monday, the New York Times reported that FDA is also looking into ROCKET-AF, but so far has not made any recommendations based on its investigation.
Sens. Bernie Sanders (D-VT), Ed Markey (D-MA), Joe Mancin (D-WV) and Lisa Murkowski (R-AK), placed holds on Califf's nomination citing his ties to the pharmaceutical industry, FDA's handling of the opioid crisis and the agency's approval of a genetically engineered salmon for human consumption last November.
On 11 February, Murkowski lifted her hold after FDA issued an import alert banning the import of the genetically engineered fish.
During Monday's vote, both Markey and Manchin were joined in opposition to Califf by Sens. Kelly Ayotte (R-NH), Bill Nelson (D-FL), Rob Portman (R-OH) and Richard Blumenthal (D-CT). Markey, Manchin and Blumenthal each took to the floor prior to the vote to criticize FDA's response to the opioid crisis.
"FDA is not using the proper safeguards to make sure the problem doesn't get worse," Markey said.
In early February, Califf and others announced a new plan to address the opioid epidemic in response to mounting political pressure that would include re-examining the risk-benefit equation for opioids, requiring advisory committee meetings for any new opioid that does not have abuse-deterrent properties, labelling changes and new risk evaluation and mitigation strategy requirements (REMS) for the drugs.
Last week, FDA also announced the first batch of new advisory committee meetings on opioids. Next week, the agency's Science Board will meet to discuss the role of opioids in medicine, challenges facing FDA and postmarket surveillance issues relating to opioids. In April and September, the agency will convene its Pediatric Advisory Committee to discuss FDA's plan for pediatric use of opioids and hear from experts on treatment guidelines, pediatric labeling and addiction deterrence.