After five months of delay, the U.S. Senate finally confirmed President Obama's bet, Robert Califf, to head the U.S. Food and Drug Administration, an agency that regulates everything from food and drugs to tobacco, cosmetics and dietary supplements.
Dr. Califf is a cardiologist, clinical trials expert and clinical researcher from Duke University and has been a consultant to drug companies.
He said one of his first priorities is to strengthen the workforce by reaching out to academic and other centers to attract new talent and create professional "homes" for scientists who work at the FDA.
In an interview, "We have been working to create a coordinated effort to have all our statisticians have an identity and support services that they need."
Another priority for Califf is improving surveillance systems to monitor for safety.
"We're not proposing to do away with the adverse event reporting system that currently exists," he said, "but we are acutely aware that it is not enough."
He also said that tools to monitor the safety of medical devices also need to be modernized and though it will not happen overnight, he will do the hard work of making it happen. Moreover, medical professions also need to "step up" and be part of the process.
Also, he said getting the authority to regulate e-cigarettes is also a priority.
The FDA is also attempting to implement sweeping new regulations to improve food safety and has begun to tackle the approval process for biosimilars, which are cheaper versions of biologic drugs.
Physician and healthcare groups reacted positively to the Senate vote. "Dr. Califf is an acclaimed leader in the cardiovascular community who brings impressive medical knowledge, clinical research experience and leadership capabilities to the FDA," said American College of Cardiology President, Kim Allan Williams Sr., MD, in a statement. "He has made important contributions to the field of medicine and has the vision required to lead the FDA in its efforts to promote and protect public health. Dr. Califf is the right person to lead the FDA."
The vote came after weeks of opposition from a handful of lawmakers who had blocked his nomination over what they said was the agency's poor record on prescription painkillers.
Some senators used the opportunity presented by Califf's nomination to question the FDA, the agency in charge of approving the drugs. In speeches on the Senate floor over several days, they appealed to their colleagues to vote against Califf, arguing the agency he had been tapped to run had approved too many of the opioid drugs and had ignored the advice of its own expert panels, which have occasionally recommended against approval.
An article from New England Journal of Medicine said that Califf listed over a dozen pharmaceutical companies in his conflict-of-interest disclosure. No previous FDA commissioner has been so closely tied to the pharmaceutical industry.
Michael Carome, director of the health research group at Public Citizen, a consumer activist group in Washington DC said, "It would be dangerously naïve to think he has not developed deeply ingrained attitudes that tilt in favor of the medical device and drug industries."
But Califf's supporters argued that he has maintained his independence. They told that they have never experienced a situation where he was not reporting the results of the studies in a fair, open, and honest way.
The Senate health committee held a hearing on November 17, 2015, to consider Dr. Califf's nomination. The Senate health committee later approved Dr. Califf's nomination on January 12, 2016.
