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Posted 04 May 2018 | By Zachary Brennan 

FDA Preps for OND Modernization

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Friday told participants at the Reagan Udall Foundation’s annual public event about plans to modernize the Office of New Drugs (OND) by as soon as the end of summer.

Gottlieb said as many as half of the Center for Drug Evaluation and Research (CDER) staff in senior roles could be retiring in the next five years.

Despite recent departures from FDA to industry, Gottlieb called the number who could be retiring “a little bit of a cliff,” but also said he did not think the number has been increasing inordinately. He said that new funds from 21st Century Cures Act will help with hiring, as the agency has altered how quickly new staff can be brought on board.

And with OND reforms, Gottlieb said CDER will look to move toward a common template for reviews as there have been a lot of redundancies with review memos.

Three former FDA commissioners also joined Gottlieb in a Q&A.

Andrew Von Aschenbach, FDA commissioner under President George W. Bush, noted that in his time, “FDA was walled off … but in terms of being embedded in a larger ecosystem, the most critical asset is its people, for growth and development.”

Former commissioner under President Barack Obama, Rob Califf, also explained more behind a push for the greater use of real world evidence (RWE), saying that it’s “a key mistake people make is that we say RWE, that we say not randomized when we mean collecting data in the real world and using randomization – a lot of the sample sizes are small.”

Mark McClellan, also an FDA commissioner under Bush, said long term transformations have to be done “in a way people trust – it’s hard in health care, we’re missing lot of opportunities to learn in the real world data – we have a lot of challenges to get there, a lot are technical issues.”


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