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Work Together, But Not Too Together

Robert Califf, the new US Food and Drug Administration commissioner, says that the agency needs to work with industry groups so that it keeps up with what's going on in the field, Stat News reports.

Prior to his confirmation, some Democratic senators raised concerns that Califf was too close to the industry that FDA regulates. When he was at Duke University, Califf oversaw its $200 million clinical research institute, which was financed by government grants and private sector funds. This led lawmakers like Senator Elizabeth Warren (D-Mass.) to question his ties. She later said he'd addressed many of her concerns and concluded Califf "conducted himself with integrity."

According to Stat News, Califf said in a talk to the Alliance for a Stronger FDA this week that FDA has to work with those who are developing new approaches so that the agency stays current. He noted that that FDA has hired people from industry and academia fluent in next-generation sequencing approaches, but since the field moves so fast, what they know is nearly out of date.

"We have to be able to interface effectively with people that we regulate, which is extraordinarily touchy territory," Califf said. "Getting this right is not something I can do; it needs to be a consensus of the community we work in."

"We have to keep our sanctity of regulation, but we have to be fluent with the outside industry, as the knowledge changes so rapidly," he added.