Biden chooses Robert Califf to head the FDA despite ties to the drug industry

Biden chooses Robert Califf to head the FDA despite ties to the drug industry


“The truth is, industry is developing drugs – you have to work with industry. It’s about disclosure in the publication, ”said Ellen V. Sigal, founder and chair of the nonprofit Friends of Cancer Research, which accepts industry funding. “Rob has done many, many clinical studies with the industry, but he wasn’t an industry pawn. He is fully committed to transparency, integrity and science. “

Dr. Aaron S. Kesselheim, who was a member of the FDA advisory panel that studied the Alzheimer’s drug and stepped down from the committee after it was approved, said Dr. Califf’s background in conducting clinical trials would be of value to running the agency.

“I don’t think this necessarily means disqualification,” said Dr. Kesselheim, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital. “I think the fact that he’s worked in clinical trials for so long shows that he has the expertise to understand what makes a good clinical trial. Hopefully he can bring that into his role as FDA commissioner. “

But dr. Kesselheim contradicted the efforts of Dr. Califf, when he was the commissioner to allow drug companies to advertise their products off-label, noted that patients can be at risk from drugs prescribed for uses the FDA has not approved. “This is a warning sign for me,” said Dr. Kesselheim. “Hopefully he’s left that behind as an idea because it would be a terrible idea.”

During his first tenure at the agency, Dr. Califf is committed to modernizing the way in which electronic health data is collected and used to answer questions about drugs and medical devices that could not be derived from clinical trials.

He also tried to increase the use of “real world evidence” – case studies and individual patient experiences – to make regulatory decisions. Some public health experts fear that reliance on data outside of randomized clinical trials puts patients at risk; Dr. Califf believes there is room for both approaches.

His willingness to consider such data sparked controversy in 2016 when the Food and Drug Administration overruled its experts to approve a new drug to treat a rare, deadly muscle disease, despite no evidence that it worked.



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Rachel Meadows

Rachel Meadows

Trending topics news writer who enjoys cooking, walking her dog and travel.

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