US Senate Clears Way for Vote on Califf FDA Nomination

Deborah Brauser

February 22, 2016

WASHINGTON, DC — Earlier today, the US Senate voted 80-6 to invoke cloture and move forward on the nomination of Dr Robert Califf as commissioner of the US Food and Drug Administration (FDA). Easily surpassing the 60 votes needed to invoke the procedure, this will remove the holds that had been put on the proceedings by some of the senators and will shut down a threatened filibuster announced previously by Sen Joe Manchin (D-WV).

As reported by heartwire from Medscape, Manchin had announced concerns about Califf's "strong pharmaceutical ties" and that the FDA wasn't taking a strong enough stance against opioid painkiller abuse. Last month, Sen Edward Markey (D-MA) called for a hold because he too was concerned about opioid medications. Both senators were among the "no's" for cloture.

Presidential hopeful Sen Bernie Sanders (D-VT) had also placed an earlier hold, citing Califf's relationships with the pharmaceutical industry, his not being committed to lowering high medication prices, and, again, opioid concerns. However, Sanders did not leave the campaign trail to register his vote.

"I don't think Dr Califf should be approved until the FDA changes business as usual," said Markey before today's vote. "It needs to recognize its responsibility to not allow this flood of drugs into society."

On the other hand, Sen Patty Murray (D-WA) said she was grateful for Califf's acceptance of the nomination "and his continuing to offer his expertise in service of families and communities nationwide."

"We need a leader who can manage a large and complex organization, not just on big policies that make headlines but on day-to-day matters," added Sen Lamar Alexander (R-TN). "Dr Califf is the right person for the job."

In essence, today's activity clears the path for a confirmation vote, which could come as early as tomorrow. However, it also allows up to 30 hours for debate prior to the official vote. And this is something Manchin and Markey say they plan to take advantage of.

Earlier Press Conference

Earlier in the day, the two senators held a joint press conference to call attention to the nationwide opioid epidemic and to reiterate their concerns with Califf's nomination.

"Joe and I are committed to having these things aired on the Senate floor. We are calling for reforms at the FDA," said Markey during the briefing. He noted that his and Manchin's states have been among the hardest hit when it comes to the drugs.

As for taking up the entire 30 hours allotted for debate, Markey said, "We're going to give it everything we've got. There's just too much ignorance on this issue" of opioid abuse.

Manchin noted that the hope, no matter what happens with Califf's confirmation, is that they've underlined the importance of the opioid threat "so that the next administration will understand that there needs to be a change," he said.

"Dr Califf is a good man. I haven't found anything at a level where he has done anything wrong," said Manchin. "But when you're in a culture where your clinical research depends on funding from pharma, I don't believe we're going to find a slowdown on those relationships whatsoever."

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