Senate confirms Dr. Robert Califf to lead FDA

[February 25, 2016]  By Toni Clarke

WASHINGTON (Reuters) - The Senate voted overwhelmingly on Wednesday to confirm Dr. Robert Califf as head of the Food and Drug Administration, an agency that regulates everything from food and drugs to tobacco, cosmetics and dietary supplements.

Califf, 64, a well-regarded cardiologist and researcher, takes the helm at the FDA when lawmakers are pressuring it to speed the approval process for drugs and medical devices and to finalize a proposed rule giving it authority to regulate e-cigarettes.

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.

For example, he said in an interview, "we've been working to create a coordinated effort to have all our statisticians have an identity and support services that they need."

"For docs like me," he added, that might mean help with administrative matters such as keeping medical licenses up to date.

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."

Tools to monitor the safety of medical devices also need to be modernized, he said, and though it will not happen overnight, "we have to do the hard work of making it happen." He said he thinks medical professions also need to "step up" and be part of the process.

And 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.

The U.S. House of Representatives recently passed the 21st Century Cures Act, which would require the FDA to consider more flexible forms of clinical trials. The Senate is considering similar legislation.

The rate of new drug approvals at the FDA is higher than it has been in decades. Last year it approved 45 new drugs, the most since 1996. From 2006 through 2014 it has averaged about 28 new drug approvals per year.

Lawmakers and patient groups want the agency to move even faster. Califf has worked on many high-profile clinical studies, and has said he is eager to make the clinical trial process more efficient.

Four senators, including Democrat Edward Markey of Massachusetts and Joe Manchin of West Virginia, opposed Califf's nomination. They took the opportunity leading up to the vote to lambaste the FDA for what they said was a lax approach to approving potentially addictive opioid painkillers.

Democratic presidential candidate Bernie Sanders was also among the senators who opposed the nomination, saying Califf's ties to the pharmaceutical industry made him unfit to regulate it impartially.

Califf joined the FDA as a deputy commissioner a year ago. Previously he held senior positions at Duke University, where he founded a large academic research center that received more than half its funding from the drug industry. He has said the funding never compromised his research.

Califf's confirmation was widely expected. He fills the position left by Dr. Margaret Hamburg, who stepped down after six years as commissioner. Dr. Stephen Ostroff has filled the post on an interim basis.

(Reporting by Toni Clarke; Editing by Eric Walsh, Lisa Von Ahn and Jonathan Oatis)

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