Now that President-elect Donald Trump has named his pick to oversee the nation's massive healthcare operations, attention turns to who will lead the FDA, with several top U.S. heart doctors expressing strong support for Robert Califf to remain commissioner.
Trump on Tuesday tabbed Georgia Congressman Tom Price, a former orthopedic surgeon and fierce Obamacare critic, to head the Department of Health and Human Services.
Califf, a cardiologist and high-profile researcher from Duke University, became the U.S. Food and Drug Administration commissioner in February. He will submit a letter of resignation as part of presidential transition protocol, which may or may not be accepted.
"Rob Califf is a very thoughtful and sensible guy, and I hope they can keep him in the FDA," said Dr. Steven Nissen, chief of cardiology at the Cleveland Clinic.
In conversations about the future of U.S. healthcare with heart doctors and researchers at the recent American Heart Association scientific sessions in New Orleans, Califf remaining at his post was high on many wish lists.
"We need to have a more nimble, more forward-thinking FDA, which was evolving under Dr. Califf's short tenure," said Dr. Clyde Yancy, a former AHA president from Northwestern University Feinberg School of Medicine in Chicago.
"We should allow that experiment to continue because the return on that investment could be enormous," Yancy said, adding that advances in drug discovery science and precision medicine could depend on who leads the National Institutes of Health and FDA.
Doctors want to see increased funding for the NIH, which they view as a critical engine for drug discovery.
Dr. Joshua Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami, said Califf was doing "a spectacular job."
"He's got the absolute right background and he was just getting started," said Hare, calling Califf "a highly respected academic cardiologist."
Califf is not without critics, including former Democratic presidential candidate Senator Bernie Sanders, who believed him too close to the pharmaceutical industry he is charged with regulating. In a distinguished research career, Califf has consulted with, or conducted clinical trials for, some two dozen drugmakers.
Those ties could work in Califf's favor, given Trump's perceived pro-business stance. PhRMA, the leading trade group for the pharmaceutical industry, declined to comment on Califf or FDA leadership.
Dr. Mary Walsh, a heart failure specialist from St. Vincent Heart Center in Indianapolis, was optimistic that bipartisan support for Califf, who was confirmed by an 89-4 U.S. Senate vote, will help him retain the post.
Walsh said Califf has sought input from various medical societies on what they would like to see from the FDA.
"I think he has a fresh approach and I personally am very hopeful that the new administration will be supportive of his continuing on as FDA commissioner," said Walsh, who will be the next American College of Cardiology (ACC) president.
Some doctors were concerned about how the next president's aversion to regulation might affect the FDA's mission.
"I worry that they may have the attitude that there's too much regulation in government in general and the FDA in particular," said former ACC President Dr. Patrick O'Gara from Brigham & Women's Hospital in Boston.
Califf has "a really broad overview of regulatory affairs as well as these issues about safety that affect patient care," O'Gara said. "I think he's terrific for the job."
Dr. Douglas Weaver, another past ACC president from the Henry Ford Health System in Detroit, said Califf should be allowed to continue.
"He's looking for things that help early regulatory approval for conditions for which there's no treatment and expediting approvals over what we've seen in the past," Weaver said. "Those are all good things."
(Reporting by Bill Berkrot; Editing by Jonathan Oatis)