Dr. Robert M. Califf, President Obama’s nominee to direct the Food and Drug Administration, “coasted through” a Senate committee confirmation hearing Nov. 17, according to Sabrina Tavernise’s account in the New York Times. Senators Elizabeth Warren and Bernie Sanders remained skeptical. Some excerpts follow:
“It’s no secret that during your time at Duke, you received significant compensation” from the drug industry, Ms. Warren said. “It naturally raises questions about your relationships with the drug industry.” Dr. Califf responded that the central repository of data for any given trial “is the really critical factor here.”
… For years, Dr. Califf ran the Duke Clinical Research Institute, a $200 million center that manages clinical trials in more than 65 countries involving more than 1.2 million patients. The budget is 37 percent government grants and 63 percent from the private sector.
… Most senators praised Dr. Califf. “I’m very impressed with what you do,” said Orrin G. Hatch, Republican of Utah, who told Dr. Califf he was concerned that drug companies were not getting enough time with exclusive rights to the drugs they develop. “You’d add a great deal to the F.D.A.”
…Thomas Marciniak, a former cardiovascular drug reviewer for the F.D.A., said he believed drug companies had too much discretion over what data they submit, a power that gives them what he said was inappropriate sway over the drug approval process. “The clinical trial system run by drug companies in this world is really broken,” said Mr. Marciniak, who left the agency last year. “I think Rob Califf is one of the architects of that. I think he should be held accountable, not appointed to run the F.D.A.”
