On Friday, May 4, 2018, United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, discussed plans to modernize the Office of New Drugs (OND) with participants at the Reagan-Udall Foundation’s annual public event.
According to Gottlieb, up to half of the senior staff currently at the Center for Drug Evaluation and Research (CDER) could be retiring in the next five years. While we have recently seen quite a few public-sector employees making the switch to the private sector, he referred to the steep number of employees that could be retiring “a little bit of a cliff.” This will likely result in a wave of new employees, and with that, a possible wave of modernization.
In anticipation, FDA officials are planning to restructure OND to “flatten the organization,” with more reviewers authorized to make decisions on review findings. This change may result in fewer bottlenecks in the review process, as noted by CDER Director Janet Woodcock at a recent annual meeting of the Food and Drug Law Institute (FDLI).
Commissioner Gottlieb explained that the aim of modernization and reorganization would be to better align new drug development and review with new types of medicines designed to target molecular changes that initiate disease, and “not just the symptoms of illness.”
This shift will require new approaches to documenting and evaluating applications, including a team-based review process that brings together staff with expertise in areas such as statistics, modeling, simulation, and advanced manufacturing to assess novel trial designs and drug development approaches.
“We want it to be easier to innovate the way drugs are developed,” Gottlieb stated during a speech at the FDLI meeting. Our professional staff members are “thought leaders in their disciplines,” he observed, “and we want to give them more time to collaborate with academic medical scientists and patients, to analyze scientific and commercial developments, and to strategically foster drug development.”
At the Reagan-Udall meeting, Gottlieb estimated that the OND changes will begin to be unveiled by the end of summer. Woodcock cautioned that such a broad and complex reorganization of such an important CDER operation will take time to move throughout the formal federal government review process, but since she and her staff have recently restructured other important efforts, she anticipates a fairly smooth and successful modernization effort in this realm.
Former Commissioners Sound Off
During the Q&A portion of the discussion at the Reagan-Udall event, three former FDA commissioners joined Commissioner Gottlieb.
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.”