A new reorganization at the FDA’s Center for Drug Evaluation and Research will assign multidisciplinary teams to work on new drug applications from the beginning of the regulatory process, will centralize project management under the Office of New Drugs, and increase the number of offices overseeing review divisions from five to nine and increasing the overall number of review divisions from 19 to 30, the agency announced June 4.
“These changes are intended to free up resources so that our scientists and physicians have more time to focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly, with appropriate input from external scientists, expert physicians and patient communities,” said Janet Woodcock, CDER director, in a blog posted to the agency’s web site.
“As always, our goals are to expand access to safe and effective new drug therapies, conduct efficient and comprehensive safety surveillance and ensure that accurate information about those drugs is available,” Woodcock said.
The reorganization adds even more to Woodcock’s portfolio. In addition to running CDER, Woodcock is also director of the Office of New Drugs. Her reorganizational proposals come as the agency struggles to meet the deadlines laid out in the 21st Century Cures Act.
“It could be that they see it as a way to help address the rollout and implementation in a more effective way,” said Julie Tibbets, a partner at Goodwin, Procter who focuses her law practice on drug regulation and policy. “That said, I think that’s a tall order that they’ve laid out for themselves.”
According to the FDA’s own web site, the Cures Act lays out some 30 “deliverables” for CDER; CDER has completed three of them.
“They keep a chart of the deliverables for the Cures Act,” Tibbets added. “They’re not tracking very well on this.”
Woodcock’s blog post was followed directly by a statement of enthusiastic support from FDA Commissioner Scott Gottlieb.
“One principal aim of these proposed changes is to elevate the role of our scientists and medical officers to take on even more thought leadership in their fields,” Gottlieb said. “We want to give our clinicians and scientists more time, better tools and greater support to advance the clinical and regulatory principles that the FDA uses to evaluate new drugs for safety and efficacy.”
In 2017, the FDA approved 46 novel drugs “100 percent of which were reviewed on time,” Woodcock’s blog says.
“Our new plan is designed to help us generate efficiencies so we can build stronger external collaboration capabilities and enhanced support for the scientific, clinical and technological innovation necessary for new drug therapies,” Woodcock said.
Tibbets said she remains skeptical. “I mean guidance documents take time. I think that this is un-realistic,” she said.