Biden to Select Robert Califf as FDA Leader Despite Pharmaceutical Industry


Dr. Califf was approved by 4 votes to 89; In addition to Mr. Manchin, Massachusetts Democratic Senators Edward J. Markey; Richard Blumenthal, Connecticut Democrat; and New Hampshire Republican Kelly Ayotte voted against him. But other Republicans, led by Kentucky Senator Mitch McConnell, who was the majority leader at the time, voted in favor.

This support may be one reason why Mr. Biden chose Mr. Califf: His election drew mixed reactions.

“It’s surprising that the White House seems really deaf about conflicts of interest and so close ties to industry,” said Diana Zuckerman, head of the National Center for Health Research, a nonprofit advocacy group.

But others, Dr. He stated that they believed Califf’s industry experience should not deter him from work, revealing his ties to publish the results of clinical trials.

“The truth of the matter is that the industry is drug development – ​​you have to work with the industry. The problem is public disclosure,” says Ellen V. Sigal, founder and president of the nonprofit Friends of Cancer Research, accepting industry funding. “Rob has done a lot of clinical trials with the industry, but he did not become a pawn of the industry. It totally depends on transparency, honesty and science.”

Serving on the FDA advisory panel that evaluated the Alzheimer’s drug and resigned from the committee after it was approved, Dr. Aaron S. Kesselheim, Dr. He said Califf’s background in running clinical trials would be valuable for running the agency.

A professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, Dr. “I don’t think this is necessarily disqualifying,” Kesselheim said. “I think the fact that he’s worked this long in clinical trials shows that he has the expertise to understand what goes into a good clinical trial. I hope he can bring that to his role as an FDA commissioner.”

However, Dr. While on the commission, Kesselheim opposed efforts to allow pharmaceutical companies to advertise off-label uses for their products, noting that patients could be endangered by drugs prescribed for uses not approved by the FDA. . “This is a red flag for me,” said Dr. Kesselheim. “I hope he left that behind as an idea, because that would be a terrible idea.”



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