The head of the FDA defends the importance of drug effectiveness

Washington Post

29 December 2016 - First things first: FDA Robert Califf says that he has not had any contact with the Trump transition team. 

That's the latest sign that the cardiologist, confirmed as FDA chief less than a year ago, will be heading back to Durham, N.C., where he's on leave from Duke University. Still, he has no regrets: “Everyone who knows me knows I have just had fun every day on the job,” he said in an interview.

Some days were presumably more fun than others. Take the controversy surrounding a drug for Duchenne muscular dystrophy. Studies did not show a clear benefit to the drug and an FDA advisory committee voted against approving it, but patient advocacy groups pushed for the drug. After much infighting, the drug was granted accelerated approval this fall by the agency's top drug-review official, and Califf allowed the decision to stand.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation