Califf’s Road to FDA Gets Rockier as Senators Place Holds on Process

For the first time along an otherwise smooth path to the post of FDA Commissioner, Robert Califf, MD, is facing some road blocks. 

Earlier this month, members of the US Senate Committee on Health, Education, Labor, and Pensions (HELP) voted unanimously to confirm the cardiologist and renowned clinical trialist for the post, a vote that cleared the way for a full Senate vote.

Over the past few days, however, 2 senators have announced they are placing holds on that vote, joining a third voice of dissent, Sen. Lisa Murkowski (R-AK). Murkowski earlier voted in favor of the nomination during the HELP committee deliberations but warned she would consider blocking the process in its next phase.

Sen. Edward Markey (D-MA) announced Monday that he will be blocking Califf’s nomination in the hopes of convincing the agency to rethink its stance on the approval of prescription opioids and, in particular, its 2015 decision to approve OxyContin for pediatric use.

On Tuesday, Sen. Bernie Sanders (I-VT), who was not present during the HELP committee vote, said he was formally placing a hold on Califf’s nomination, saying he shares Markey’s concerns. He also reiterated concerns he has raised in the past that Califf is not committed to making prescription drugs affordable, saying that the former Duke Clinical Research Institute director’s “extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans.”

Murkowski, meanwhile, is pushing for mandatory labeling of genetically engineered salmon and, said during the HELP committee meeting that she was disappointed with an FDA decision to approve the marketing of a genetically modified fish with voluntary labelling requirements. That decision, she said, came just 2 days after she had raised this subject with Califf directly, while he was serving as FDA deputy commissioner.

Placing a hold on a confirmation vote effectively blocks the process from moving on to a full Senate vote, although holds can ultimately be defeated if at least 60 senators vote to lift a hold and move forward.

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