Two key Democratic senators aren’t budging from their opposition to President Obama’s pick to lead the Food and Drug Administration.
The Senate is expected to hold a procedural vote Monday on Robert Califf’s nomination to lead the FDA, needing 60 votes to clear procedural hurdles. After that vote is done, it will trigger a 30-hour debate and then a final vote will be held in which only a simple majority is needed.
Sens. Joe Manchin, D-W.Va., and Ed Markey, D-Mass., both placed procedural holds on the nomination. While saying during a press conference Monday that Califf is a “good man,” the senators are concerned about his ties to the pharmaceutical industry.
Manchin said he wouldn’t necessarily filibuster Califf’s nomination but will speak about the culture of the FDA and the need for the agency to rein in opioid approvals.
Manchin and Markey have been upset with the FDA’s decision to approve several controversial opioids. Those decisions include a kiddie-sized version of the popular opioid Oxycontin and a 2013 approval of Zohydro, a powerful painkiller that didn’t have abuse-deterrent technology.
The senators said the agency’s failure to listen to experts advising against the Zohydro approval and not seeking advice on the kiddie-version of Oxycontin illustrate a failure to recognize the problem of opioid abuse.
“The agency has failed to consider pubic health in approving opiates,” said Manchin during a press conference at the Capitol.
So far no Republicans have made objections to Califf’s nomination.
Sen. Lisa Murkowski, R-Alaska, was concerned about the agency’s approval of manmade salmon. But those concerns appear to have been allayed as Murkowski, who comes from a state with a robust seafood industry, lifted any opposition to Califf.
Without any Republicans opposing the nomination, Manchin acknowledged that opposition faces an “uphill fight.”
Markey said the two senators are trying to build support against Califf but couldn’t say who may join them in opposing his nomination.
Manchin and Markey are concerned about Califf’s ties to pharmaceutical manufacturers and whether he can change the culture at the agency surrounding opioid approvals. Califf was a researcher at Duke University before becoming the deputy commissioner of medical products at the FDA.
He has conducted clinical trials for pharmaceutical giants such as Merck and Novartis.
“If Califf is confirmed, I do not feel confident this culture change will happen any time soon,’ Manchin said.
Trying to head off the opposition, the FDA recently put Califf in charge of a new review of the agency’s opioid policies. Those include an advisory committee to look at any opioid submitted for approval but does not have any abuse-deterrent technology.
Such technology makes a pill virtually impossible to crush or snort, which are common methods addicts use to get a faster high.
The agency also announced last week new meetings of its science board on opioid use and the agency’s role in the development of painkillers.
Markey wants the FDA to go further, saying the advisory committee also should look at any drugs with abuse-deterrent technology.
“Abuse-deterrent opioid is a contradiction in terms, like jumbo shrimp or congressional expert,” he said.
