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Califf Confirmed

In an 89-to-4 vote, the US Senate has confirmed Robert Califf as commissioner of the Food and Drug Administration, the Wall Street Journal reports.

Califf tells the Journal that, as commissioner, he will focus on using databases and electronic medical records to catch when drugs and medical devices might not be working properly.

This, he says, should provide "pretty good information about how a product is performing." That way, he adds, FDA would be more actively looking for issues rather than waiting to be informed about them.

The Journal notes that Califf also supports the use of identification numbers on medical devices so that the agency can better determine whether an issue that crops up is isolated or widespread. "It is going to get done," Califf tells the Journal. "The question is when. It's a very high priority for the FDA."

The WSJ further adds that Califf garnered the support of both Republicans and Democrats. The votes against his confirmation came from Kelly Ayotte (R-NH), Richard Blumenthal (D-Conn.), Joe Manchin (D-WV), and Edward Markey (D-Mass.) Manchin and Markey opposed his nomination due to FDA's lenient approval of painkillers that they say have fueled opioid addiction. Califf tells the Journal that the agency will try to respond to the issue.

Manchin and other senators also objected to what they saw as a close relationship between Califf and the pharmaceutical companies FDA oversees, Stat News notes. While at Duke, Califf ran its $200 million clinical research institute, which was financed by both government grants and private sector funds.

"I believe the FDA must break its cozy relationship with the pharmaceutical industry," Manchin tells Stat News, adding that Califf is "just not that person with the passion to change the culture in this important agency. We've let the sleeping giant go far too long."

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