Senators Place Holds On FDA Commissioner Appointment
Senators Bernie Sanders (I-Vt.) and Edward Markey (D-Mass.) have placed a hold on President Barack Obama’s nominee for FDA commissioner, Dr. Robert Califf. Sanders has voiced concerns about Califf’s ties to the pharmaceutical industry, and Markey is asking the FDA to reform the agency’s approval process for opiate drugs.
Califf — a cardiologist and clinical research expert from Duke University — has served as deputy FDA commissioner since February 2015 and has been the presumed nominee for commissioner since Margaret Hamburg stepped down last March.
“Dr. Califf’s deep knowledge and experience in the areas of medicine and clinical research will enable the agency to capitalize on, and improve on, the significant advances we’ve made in medical product development and regulation over the last few years,” said Hamburg, in a statement following Calliff’s appointment as deputy last year.
During a November confirmation hearing with the Senate Committee on Health, Education, Labor and Pensions, Sanders and Elizabeth Warren (D-Mass.) questioned Califf’s industry ties, principally his work running the Duke Clinical Research Institute (DCRI), which manages clinical trials in 65 countries and receives 63 percent of its funding from the private sector.
According to the New York Times, Califf maintained that the DCRI requires unfettered access to clinical trial databases and walks away from dealings with any company who refuses to grant that access. He also stated that contracts between the DCRI and industry would be made public, upon request. Furthermore, he stated he had donated all of his industry consulting fees to nonprofits.
Sanders released a statement in October saying he had reservations about Califf and his ability to serve America’s best interests, adding that he would block attempts to appoint Califf as FDA commissioner, reported the Washington Post. Despite objections, the committee voted to appoint Califf earlier this month, said Reuters.
Though Sanders has been the most outspoken opponent of Califf’s confirmation, Sen. Markey was the first to place a hold, which informally states the senator’s objections to the majority leader. While a hold is not binding, it does indicate a prolonged process, which Majority Leader Mitch McConnell may want to avoid.
Unlike Sanders, Markey’s principal concerns lie with the FDA itself, which recently approved Oxycotin for pediatric use. In a letter to the Department of Health and Human Services Secretary Sylvia Matthews Burwell, Markey stated he did not believe Califf would “confront the highly problematic manner in which the agency is approaching” opiate drugs, reported Bloomberg.
Hours later, Sanders also placed a hold, agreeing with Markey’s sentiments about the FDA’s approach to addiction while reiterating his concerns about the price of drugs in the U.S.
“I strongly believe that at a time when millions of Americans cannot afford to purchase the prescription drugs they require, we need a leader at the FDA who is prepared to stand up to drug companies,” stated Sanders.
While the FDA did not comment on the senators’ remarks, the Washington Post cited Califf’s statement at his confirmation hearing last November.
“I think if you look at my record, I’ve never been a proponent of lowering standards. If anything I’ve argued for raising them. I think I’ve been staunch in that regard,” said Califf.
Aside from objections from Sanders and Markey, Califf has broad bipartisan support and most expect him to eventually be confirmed as FDA commissioner.