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Pink Sheet – The End Of ‘Regulatory Science’ At US FDA – The Term, Not The Idea

Pink Sheet – The End Of ‘Regulatory Science’ At US FDA – The Term, Not The Idea

Executive Summary

Former Commissioner Margaret Hamburg made advancing regulatory science a centerpiece of her tenure, but it sounds like the term ‘regulatory science’ has outlived its usefulness.


The directors of the US FDA’s drug and biologic centers really don’t like the term “regulatory science.”


Center for Drug Evaluation & Research Director Janet Woodcock and Center for Biologics Evaluation & Research Director Peter Marks made their feelings known during a panel discussion as part of the Prevision Policy/Friends of Cancer Research Biopharma Congress Nov. 14.


During a discussion of the current regulatory climate at FDA and ideas to build on the strong performance of new drug review teams, session moderator Jeff Allen (CEO of Friends of Cancer Research) mentioned “regulatory science” during a question about efforts like the Critical Path Initiative and their impact on FDA’s performance.


Woodcock took the opportunity to make clear that she does not consider the term helpful in advancing the goals she has long championed for advancing translational research via collaboration. Marks followed up by agreeing that that term is too broad and vague to be useful.


“Advancing Regulatory Science,” of course, was a signature initiative of the tenure of former FDA Commissioner Margaret Hamburg, who launched a formal initiative by that name shortly after joining the agency in 2010. (Also see “Hamburg Outlines The Potential Of Regulatory Science Investment” – Pink Sheet, 11 Oct, 2010.) Nearly three years after Hamburg left FDA, it still lives on, at least in the form of a dedicated landing page within FDA’s website.

‘A Lot Of Progress Has Happened’

So it was somewhat surprising for Woodcock to react to the term like it was fingernails on a chalkboard. “As you know, I don’t like the term ‘Regulatory Science,’” she began. “The intent [of the Critical Path Initiative] was to make the community wake up and realize there is a big gap. You have to do translational science. You can’t just do basic science. … This takes a long time.”


“In the early 2000s … the only people who understood that other than the FDA was the companies, and they were so secretive with everything, there was no sharing of information,” Woodcock said. So the idea was “to get a body of knowledgeable people and researchers going who understood what needs to get done.”


“A lot of progress has happened,” she added, citing specifically the C-PATH safety biomarkers initiative, which involves two dozen companies pooling preclinical safety markers. So “it has been successful, whatever they call it.”


“If they want to call it ‘Regulatory Science’ that’s – well, it’s not alright with me, but that’s what they are going to call it,” she said.

‘A Wastebasket Term’

“Janet, we are in unison here,” Marks added. “Regulatory Science” has “become a wastebasket term.” He particularly objected to the confusion between “science” and “policy” that he thinks the term engenders.


“I went to a meeting and this guy handed me his card and said, ‘I’m the head of the Institute of Regulatory Science,’” Marks said. “I started to talk to him and he looked at me like I had three heads. Because he was a policy wonk. He didn’t do anything that I considered regulatory science.”


“We should speak about what we are talking about. We do applied scientific research at our center. We might do a touch of basic science because you just wander into it sometimes, but the goal is to do applied scientific research that actually makes a difference directly to the products that we regulate.”


“Then there is the statistical and epidemiological research that we do which is very important. Statistical methods to come up with ways to streamline small trials and draw a statistical inference from them or to use real world evidence,” he said, as well as “epidemiologic data to make sure that the products we regulate are actually safe in large populations.”


“Naming them makes more sense than this wastebasket term,” Marks said. “Policy is really important, don’t get me wrong, it really is. But we do a disservice to policy when we just lump it in this mess.”…