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www.fdanews.com/articles/175304-senators-to-maintain-holds-on-califf-despite-opioid-announcement

Senators to Maintain Holds on Califf Despite Opioid Announcement

February 11, 2016

Sens. Joe Manchin (D-W.Va.) and Edward Markey (D-Mass.) will maintain their holds on the nomination of Robert Califf for the top job at the FDA, despite the agency’s announcement that it would overhaul its opioid policies.

Specifically, the FDA said it would reexamine its approval, REMS and postmarket policies for opioids in response to a growing abuse epidemic and calls to action from lawmakers.

The senators — along with Sen. Bernie Sanders (I-Vt.) — in January placed holds on Califf’s nomination, with all three citing the FDA’s handling of approving prescription opioids.

A spokeswoman for Manchin saidthat the senator’s plans have not changed, and he still plans to filibuster and hold Califf’s nomination. Manchin said the FDA’s announcement that it would re-evaluate its risk-benefit framework for the drugs will only “slightly improve” the agency’s response to the opioid epidemic, and that “sweeping changes” are still necessary.