The FINANCIAL — President Barack Obama plans to nominate the prominent cardiologist and medical researcher Robert Califf as the next commissioner of the Food and Drug Administration, the White House said on September 15, according to Nasdaq.
Dr. Califf had been named the FDA’s deputy commissioner for medical products and tobacco—effectively the No. 2 post—in February. He joined the FDA from Duke University, where he had served as a professor of medicine, a leading pharmaceutical researcher and the vice chancellor for clinical and translational research.
He is a well-known figure in medicine, distinguished by a leadership role in a wide range of clinical studies. He has been expected to be nominated for the top job ever since he joined the agency.
His nomination isn’t expected to be controversial in the Senate, which must vote to confirm him to the post. “Unless they’re looking for a reason to slow this down to score points, he should get relatively quick approval,” said one federal official who deals frequently with Congress.
His predecessor, Margaret Hamburg, served six years as FDA commissioner in the Obama administration, until her resignation in March. Dr. Califf had been considered by the White House for the top job at the time President Obama selected Dr. Hamburg, according to FDA officials. Since her departure, Stephen Ostroff has served as acting commissioner.
Francis Collins, director of the National Institutes of Health and a scientist who has worked with Dr. Califf for years, called this “a fantastic nomination.”
“I hope that Congress will respond quickly,” Dr. Collins said. “He has such a wealth of experience in how to do research.”
Diana Zuckerman, president of the National Center for Health Research, a Washington-based group focusing on medical- product safety, questioned his ties to the drug industry.
“Dr. Califf’s expertise and his close ties to the pharmaceutical industry are both well-known,” she said. “His ties to industry have been a source of great concern to public-health experts when he was previously considered for FDA commissioner, and those ties raise important questions about this nomination.”
The FDA said Dr. Califf, 63 years old, wasn’t immediately available for interviews. Senior officials of the FDA said they’re uncertain what direction he may take the agency, but said one issue important to him is an effort to create more openness regarding data from clinical trials.
Another question facing the FDA now is the degree to which it will speed up clinical studies—something being urged by Republicans in the House of Representatives. The agency already has found multiple ways of expediting approvals of drugs, especially cancer drugs and antibiotics. The 21st Century Cures Act, approved by the House, calls for other ways to speed drug approvals.
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