(Updated on January 26 and January 27)
US Senator Edward Markey, a Democrat from Massachusetts, is seeking to block Rob Califf’s nomination to head the FDA, according to a report in the Boston Globe. Markey will use Senate rules to place a hold on the nomination.
In September President Obama nominated Califf, a well-known Duke University cardiologist and clinical researcher, to head the FDA. After a generally positive reception at a hearing of the Senate’s Health, Education, Labor and Pension Committee in November, the committee voted earlier this month to move the nomination to the entire senate for a vote.
Markey is using the hold to punish the FDA for its approval last year of the use of OxyContin in children. Markey is particularly concerned that the approval came without an FDA advisory committee meeting. He wants the FDA to rescind the approval and to promise to hold advisory committee meetings before new approvals of any prescription opiods.
Two other senators have voiced strong opposition to Califf’s nomination. Senator Lisa Murkowski, a Republican from Alaska, wants the FDA to require labeling of genetically modified fish. Presidential candidate Bernie Sanders (Vermont independent) said Califf’s deep ties to industry disqualify him for the job.
In a letter to Health and Human Services (HHS) secretary Sylvia Mathews Burwell, Markey wrote that Califf “did not give me confidence that under his stewardship the FDA would confront the highly problematic manner in which the agency is approaching these issues.” In a statement to the Globe HHS said that it “will be in touch directly with the senator regarding his concern.”
Any US senator can place a hold on a nomination. A supermajority of 60 senators can override the hold.
Update, January 26:
On Tuesday Sanders officially announced that he had placed a hold on Califf’s nomination “because of his close ties to the pharmaceutical industry and lack of commitment to lowering drug prices.” Sanders also said that he shares “Sen. Markey’s concerns that the FDA must change the way it approaches addiction.”
Update, January 27:
On Wednesday a fourth senator, Joe Manchin, a Democrat from West Virginia, announced that he was also opposed to Califf’s nomination. He said he would filibuster the nomination because of Califf’s “strong ties to the pharmaceutical industry.” Manchin said that Califf “is not the champion the FDA needs to tackle” the prescription opioid epidemic.
Califf’s nomination may be in jeopardy but the key stumbling block isn’t the four senators who have announced their opposition. The key figure is Senate Majority Leader Mitch McConnell. According to a report in Morning Consult, McConnell has the power to move the nomination to the senate floor for a vote, but he may not want to displease his fellow Republican Lisa Murkowski. If McConnell does allow the vote Califf will likely prevail, the story states.