December 3, 2021

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Biden to Select Robert Califf to Lead F.D.A., Regardless of Drug Trade Ties

Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties

Dr. Califf was confirmed for the job in a vote of 89 to 4; along with Mr. Manchin, Senators Edward J. Markey, Democrat of Massachusetts; Richard Blumenthal, Democrat of Connecticut; and Kelly Ayotte, Republican of New Hampshire, voted in opposition to him. However different Republicans, led by Senator Mitch McConnell of Kentucky, then the bulk chief, voted in favor.

That help could also be one purpose Mr. Biden picked Mr. Califf: His choice drew combined response.

“It’s shocking that the White Home has appeared actually tone-deaf on conflicts of curiosity and really shut ties to the trade,” stated Diana Zuckerman, the president of the Nationwide Heart for Well being Analysis, a nonprofit advocacy group.

However others stated they believed that Dr. Califf’s trade expertise shouldn’t bar him from the job, noting that he has disclosed his ties in publishing the outcomes of medical trials.

“The reality of the matter is trade develops medication — it’s important to work with trade. The difficulty is disclosure in publication,” stated Ellen V. Sigal, the founder and chairwoman of the nonprofit Mates of Most cancers Analysis, which accepts trade funding. “Rob has carried out many, many medical trials with trade, however he has not been a pawn of trade. He’s utterly dedicated to transparency, integrity and science.”

Dr. Aaron S. Kesselheim, who served on the F.D.A. advisory panel that thought of the Alzheimer’s drug and resigned from the committee after it was permitted, stated Dr. Califf’s background operating medical trials could be worthwhile for main the company.

“I don’t assume it’s essentially disqualifying,” stated Dr. Kesselheim, a professor of medication at Harvard Medical Faculty and Brigham and Ladies’s Hospital. “I feel the truth that he labored for such a very long time in medical trials demonstrates that he has experience in understanding what goes into a great medical trial. Hopefully, he can carry that into his function as an F.D.A. commissioner.”

However Dr. Kesselheim objected to Dr. Califf’s efforts, when he was the commissioner, to permit drug corporations to promote off-label makes use of for his or her merchandise, noting that sufferers might be endangered by medication which are prescribed for makes use of that the F.D.A. has not permitted. “That to me is a crimson flag,” Dr. Kesselheim stated. “Hopefully, he’s moved previous that as an concept, as a result of it could be a horrible concept.”

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