President Obama’s nominee to lead the Food and Drug Administration has a long history of close ties to industries the agency regulates. At Dr. Robert Califf’s confirmation hearing on Tuesday, senators will need to ask whether those connections will influence his judgment about the safety or effectiveness of prescription drugs.
In recent years, the F.D.A. has approved two diet drugs that European regulators have deemed too risky, leaving the impression that it gives in to industry demands over safety. A new commissioner must be strong enough to protect the agency against such pressure from industry and from members of Congress who believe the approval process for drugs and devices should allow faster approvals with less scientific evidence.
Dr. Califf had a distinguished career as a cardiologist and clinical researcher at the Duke University Medical Center from 1982 to 2015 before he joined the F.D.A. early this year as a deputy commissioner. His nomination has been supported by medical organizations, including the American Academy of Pediatrics and the American Association for Cancer Research, which believe that he will find ways to make drugs more effective, safer and cheaper.
On Thursday, the Project on Government Oversight, an advocacy group, reminded the public that Dr. Califf helped design and oversee a clinical trial of a blood thinner, Xarelto, made by Johnson & Johnson, and argued for its approval. The F.D.A. approved the drug in 2011, even though its primary reviewers had objected, saying design and execution flaws biased the trial in favor of the drug. In 2012, Johnson & Johnson paid Dr. Califf $87,500. Twenty percent of it was a management fee; the rest was for his consulting, and he donated that to charity.
In 2014, Dr. Califf gave a speech to researchers, lawyers and industry experts in which he described regulation as a “barrier” to biomedical innovation. The senators need to press him on whether he plans to modify or even weaken regulations to make them less of a barrier.
“Senator Bernie Sanders of Vermont, a member of the committee, has opposed the nomination because he considers Dr. Califf’s ties to industry too broad and deep. He is concerned that Dr. Califf would do little to help reduce the high prices of some drugs by, for example, allowing cheaper versions of the drugs to be imported from other advanced nations.”
Dr. Califf’s task is to show that he will be able to guard the public interest and resist industry pressures.