ASHINGTON – The new Food and Drug Administration chief says the agency has to work with industry groups so it can keep up with the latest developments in medical science — because otherwise, even the agency’s best experts will fall behind.
In a wide-ranging talk Tuesday to the Alliance for a Stronger FDA, a group devoted to increasing the agency’s funding, FDA Commissioner Robert Califf revisited the big issue critics raised before his confirmation nearly two months ago: the need for the agency to stay independent of the industry group it regulates.
At the time, some Democratic critics worried that he was too close to the pharmaceutical industry, and Califf eventually convinced most of them that he would stay independent. On Tuesday, however, Califf insisted that in order to stay up to date on breakthroughs in science and technology, the FDA must work with those who are developing the innovations.
“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 said.
Califf was confirmed by an overwhelming Senate majority on February 24, five months after President Obama nominated him. It was a long haul, in part because some opponents did not like research he conducted or oversaw at Duke, much of which was funded by pharmaceutical firms.
But today, in front of 80 people from patient advocacy groups, corporations, and trade groups, Califf insisted that the FDA’s relationship with industry is a practical reality.
He noted, for example, that in “next-generation sequencing” — new technologies that allow fast sequencing of a person’s DNA or entire genome — the FDA is hiring people from industry and academia who have the expertise to handle the science.
“Six months after they are on the job, they are out of date already,” he said.
Califf also said he wanted to boost morale at the agency. He told the group that the “knowledge revolution” in the biological sciences, medicine, and information technology made it crucial to keep FDA employees happy.
“We want a happier, more satisfied group of employees who can progress in their professions,” he said.
For starters, he added, “we’re working on the parking issue.”