Former FDA commissioner defends agency in Life Science event keynote

The U.S. Food and Drug Administration is a “Mysterious organization that is poorly understood,” said Robert M. Califf, M.D., former FDA Commissioner and medical professor at Duke University.

In a keynote address at the CED Life Sciences Conference in Raleigh, Califf outlined the FDA’s mission and what it needs to do to adapt to a “rapidly changing world.”

The bottom line is that the regulatory system works because it is tested and refined every day, he said, but acknowledged that it is far from perfect. Works pretty well now but needs to adapt to a rapidly changing world.

Every element of the FDA is supported by law, regulation, guidance and precedent, he said. In fact, the U.S. legal system privileges FDA precedent because it is science based – something that could be threatened if it become politicized, he warned.

He noted that the FDA is a referee and operates by a rule book, but it does not interpret rules.

Most helpful changes to the system come from people with actual experience with product development trying to make the system better, he said, suggesting the industry professionals present be part of that.

“People inside the FDA are looking for interaction independent of evaluation of individual products,” he said.

“The FDA affects us all. Appreciate it and work with it,” Califf said. “There is a read desire among the 22,000 people at the FDA to interact with people from the real world.”

Califf said the organization certainly faces challenges just as society does. The use of electronic nicotine delivery products is worrisome because nicotine is one of the most addictive substances on Earth, equivalent to opioid addiction and they’re being heavily used by young people.

“The opportunities for medical technology are unbounded,” he said. New genetic tools, regenerative medicine and digital data collection all offer significant advances in medicine and could help streamline the approval process, but we still have to ask “When should we allow a product to go to market?”

“We not only need to create great technology, but also have to think about how it is going to be deployed,” he said.

Califf, who stepped down from the FDA in January, said we should expect events such as the Ebola crisis and Zika virus every few years now because of the global nature of the world. “We are all bound together biologically,” he said.