Amy Comstock Rick joined the FDA last November, and she not only survived the widespread staff cuts last week, she’s one of only a handful of FDA officials to speak at a live conference since the Trump administration took over.
Rick told a crowd of mostly pharma industry employees and analysts at the Biopharma Congress on Monday in Washington that the CDER-CBER joint rare disease hub that she directs is continuing on despite the recent reduction in force.
While her team lost only one member to the sweeping job cuts that happened last week, she also noted, “There’s no doubt that the staffing changes that occurred both in February and last week will impact the work of the staff.” She added that the hub’s goals are non-partisan.
Rick explained that the goals of the hub are the same as they were when it was first created in July: to centralize and better coordinate the 18 rare disease programs that FDA oversees and to improve internal coordination between CDER and CBER, making their communications more regular and to dispel “seeming inconsistencies” between the two centers. The agency has previously struggled to standardize what evidence and trial designs can help it best evaluate therapies for rare conditions, particularly when there are very small numbers of patients who could participate in a trial.
She said there’s a need for the patient voice to be heard earlier in the drug development process. An upcoming workshop in June that’s still on the schedule for now, she said, will focus on designing clinical trials for small rare disease populations. She also said to be on the look out for a Federal Register notice on a request for comment for future, higher-level scientific workshops.
Rick told Endpoints News after her talk that the other members of her team are on loan from CDER and CBER, and that it remains to be seen what the full impact of the staff cuts will mean for the hub.
She was the only official from the FDA to speak at the annual Biopharma Congress this year, which has seen dozens of FDA speakers in the past. Initially, the conference planned to include newly departed CBER chief Peter Marks and Oncology Center of Excellence director Rick Pazdur, both of whom fell off the schedule in recent months.
‘Like flat-earthers taking over NASA’
Former FDA leaders, however, spoke out against the staff cuts at the meeting. Janet Woodcock, former CDER director and acting FDA commissioner, was the most critical among several other high-profile ex-FDA officials who spoke at the meeting.
“This is a slow-moving catastrophe,” Woodcock said, comparing Robert F. Kennedy Jr.’s team taking over HHS to “like flat-earthers taking over NASA.”
Former deputy director of policy Frank Sasinowski noted that he had two meetings with CDER and CBER last week and he’s impressed by their dedication, but he said the building looks like “a zombie movie set.”
Former principal deputy commissioner Josh Sharfstein, meanwhile, noted that when Kennedy said 20% of the layoffs might be a mistake, “that blew my mind.” The Johns Hopkins vice dean added that the first order of business for the FDA needs to be: Who can we bring back?
https://endpts.com/rare-disease-hub-at-cder-and-cber-faces-new-reality-with-staff-crunch/
