Today, a Senate committee will consider whether or not President Obama’s nominee, Dr. Robert M. Califf, is the one to lead the Food and Drug Administration.
Califf, who is a cardiologist, clinical trial expert from Duke University and has served as deputy commissioner of the F.D.A. since February, has received some criticism regarding whether or not he can be impartial considering his ties to the pharmaceutical industry.
One clear critic is Senator and presidential candidate Bernie Sanders, who is sharply focused on lowering drug prices.
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“At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the F.D.A. who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices,” Senator Sanders said, according to The New York Times. “Unfortunately, I have come to the conclusion that Dr. Califf is not that person.”
Others believe Califf is entirely credible and would be an asset to the administration.
Dr. Robert Harrington, the chairman of the Department of Medicine at Stanford University, used to work with Dr. Califf at Duke and says he was known among scientists as a strong advocate for transparency in drug trials. “He has been a leading voice in academic circles for strict contractual relationships that guarantee independent access to research data and the full, unfettered right to publish regardless of findings,” Harrington said.
Again, on the other side, Thomas Marciniak, a former cardiovascular drug reviewer for the FDA isn’t sold. He told The Times that he reviewed several trials that Califf conducted at the Duke Clinical Research Institute, and he believes bias was in place in order to make drugs look better than they actually were.
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“The clinical trial system run by drug companies in this world is really broken,” said Mr. Marciniak. “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.”
A final decision will not be made today, but if Califf is confirmed, he will be head of the agency that regulates about a quarter of every dollar spent in the United States.
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