Robert Califf, President Obama’s nominee to lead the Food and Drug Administration, argued before a Senate panel Tuesday that he wasn’t unduly influenced by pharmaceutical companies while participating in trials to test their products.
Califf was facing the Senate Health, Education, Labor and Pensions Committee for a confirmation hearing to replace former FDA Commissioner Margaret Hamburg. The cardiologist and Duke University researcher recieved a warm welcome overall, with several lawmakers voicing their intention to vote to confirm him, but also faced some questions about his close ties to the drug industry.
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Sen. Patty Murray, top Democrat on the panel, asked Califf how he could lead the FDA “without any undue influence.” “In the consulting work you’ve done, how have you ensured industry views haven’t biased your views?” she asked.
Califf said the final papers explaining the results of clinical trials operate under an “ironclad” contract keeping companies from influencing what they say.
“We publish the papers with input from the companies, but they have absolutely no right to what we say, we have the final right of publication,” Califf said.
But Califf also got a warm welcome from lawmakers on both sides of the aisle. Murray said she has decided to support Califf’s nomination and urged her colleagues to do the same. Sen. Barbara Mikulski, D-Md., also said she will support him, and Chairman Lamar Alexander, R-Tenn., praised his credentials.
“Dr. Califf has an impressive history of leadership and experience,” Murray said. “Our review of his record demonstrates a longstanding commitment to transparency.”
Other senators, including Democratic presidential contender Bernie Sanders, are opposing Califf’s nomination, over concern about the work Califf has performed and the compensation he has received from pharmaceutical companies. Sen. Elizabeth Warren, R-Mass., asked Califf to explain whether some of his past criticisms of the FDA would lead him to lower safety standards in the agency.
“In no case would we argue to lower the standards,” Califf replied. “Americans depend on safe drugs and devices. I think I’ve been staunch in that regard.”
Califf’s nomination comes as drug prices top people’s healthcare concerns. The recent skyrocketing cost of commonly used drugs to treat illnesses caused by hepatitis C or HIV/AIDS has raised many fears that it will be increasingly difficult for people to buy lifesaving treatments they need.
Sen. Al Franken, D-Minn., questioned Califf on the mechanisms he would use to try to help lower drug prices. Califf said he would address the agency’s backlog of applications for generic drugs. He would improve the process of approving new biologic drugs, as another way to increase competition. He would take steps to streamline clinical trials. And he said he would help the agency keep better track of drug shortages.
“When it comes to costs, we do have some tools we can use,” Califf said.
