Dr. Robert Califf will face questions about his ties to the pharmaceutical industry in a Tuesday Senate hearing on his nomination to head the federal government’s oversight agency ensuring food and drugs are safe.
A cardiologist and longtime researcher at Duke University, Califf is President Obama’s nominee to replace Margaret Hamburg as the top official at the Food and Drug Administration. In a confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, he is expected to tout his work with developers of new lifesaving drugs and technologies for patients with heart attacks, including defibrillators, stents and medications that break up blood clots.
While it’s feasible the Senate could confirm him before Obama leaves office, with many members so far mum on whether they will support him, Califf will have to answer some tough questions, particularly from Democrats, about his close work with drugmakers on testing their products.
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Califf is the founder of Duke Clinical Research Institute, which conducts studies for companies trying to get new medications and devices approved by the FDA. And that experience, while giving him useful insight into how the FDA works and what reforms are needed, also means he has worked for companies often at odds with the agency.
And then there’s Califf’s compensation. Last year, six drugmakers contributed to his salary, and he received payments from several others for consulting work.
He likely will try to dispel some of the questions by emphasizing his ability to guide the agency in negotiations with pharmaceutical companies while ensuring the agency makes independent determinations of whether their products are safe.
Senators from both sides of the aisle are sure to drill Califf, including committee Chairman Lamar Alexander, who is shepherding legislation to reform the way new medications are tested, approved and brought to market.
An aide to the Tennessee Republican told the Washington Examiner the senator is particularly interested in how Califf would speed up the FDA’s approval process for generic drugs, a reform that could help lower the skyrocketing prices of some drugs by introducing more competition.
“Sen. Alexander will be interested in discussing Dr. Califf’s qualifications to run the agency as well as the FDA’s backlog of applications for generic drugs, especially in light of the agency’s collection of nearly $1 billion in user fees from generic drugmakers over the last three years,” the aide said.
“He would also like to hear how he will help the agency bring safe drugs and devices into patients’ medicine cabinets and doctors’ offices more quickly,” the aide added.
Sen. Patty Murray, top Democrat on the committee, hasn’t said whether she will support Califf, but her office has said the two met earlier in the fall.
Other members of the committee have been more vocal about his nomination. Democratic presidential contender Sen. Bernie Sanders is opposing Califf, raising questions about his ability to reduce drug prices. Republican Sen. Richard Burr, who is from Califf’s home state of North Carolina, will voice his support for the doctor while introducing him at the Tuesday hearing.
Califf has received some crucial support from the medical community for the nomination, including a strong endorsement from the New England Journal of Medicine.
Editor-in-chief Jeffrey Drazen defended Califf from accusations of being too closely tied to pharmaceutical companies, noting that he has reported negative outcomes from industry-sponsored clinical trials more times than he has reported positive outcomes.
“Given this performance, it is impossible to argue that Califf has a pro-industry bias,” Drazen wrote. “Califf’s experience, his proven leadership abilities, his record of robust research to guide clinics practice and his unwavering dedication to improving patient outcomes are unsurpassed qualifications for the post of commissioner of the FDA.”
