More than 20 years ago President Bill Clinton left David Kessler, an appointee of the first President Bush, to run the FDA when Clinton took office. The question now is whether history will repeat as the future of FDA Commissioner Dr. Robert Califf is in play.
Some fans hope so, reports Reuters, which talked with top cardiologists at the American Heart Association (AHA) meeting in New Orleans.
“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."
Califf, who only took over the FDA in February after President Obama’s pick Margaret Hamburg resigned, is expected to soon turn in his letter of resignation. That is standard procedure of top appointees with a change in administration.
President elect Donald Trump doesn’t have to accept the resignation, but with the exception of Kessler, every FDA Commissioner has been replaced by a new president.
Califf has his critics, including Sen. Bernie Sanders who accused him of being too close to the industry, but there are also concerns about what could happen at the FDA with another new commissioner.
Trump’s pick to head Health and Human Services, to which the FDA director ostensibly answers, is Rep. Tom Price, a Republican from Georgia. Price's main healthcare focus in recent years has been on ways to dismantle the Affordable Healthcare Act.
Any change would come at an uncertain time for the agency. The 21st Century Cures Act—passed by the House of Representatives this week—has some people concerned, inside the FDA and out, that it will lead to lower drug approval standards by the agency to be more responsive to public pressure.
That worry already was raised with the FDA’s controversial approval of Sarepta's Duchenne muscular dystrophy medicine Exondys 51 (eteplirsen) against the advice of its own advisory committee, although there was strong public support from families of patients. CDER head Janet Woodcock “overruled” concerns about the drug’s approval. The internal FDA review staff reportedly appealed that decision to Robert Califf, MD, who upheld Woodcock’s decision.
Califf did have strong bipartisan support when he was named to replace Hamburg, being approved on a vote of 89-4.
Dr. Mary Walsh, a heart failure specialist from St. Vincent Heart Center in Indianapolis, tells Reuters she hopes he is retained. She will be the next American College of Cardiology (ACC) president.
"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," she said.