FDA Workload Likely to Increase Post-Pandemic: Officials
Officials from CDER and CBER told a Biotechnology Innovation Organization digital conference that they anticipate a busier agency workload after the emphasis on the Covid-19 pandemic eases. An online report on the meeting posted by the Regulatory Affairs Professionals Society says that while drug companies and FDA officials are working with unprecedented speed and creativity during the pandemic, “there’s little reason to think the workload will abate, or the problems become easier, in the post-pandemic lives of sponsors and regulators.”
CDER Office of New Drugs director Peter Stein said the Center has remained “pretty effective” at meeting PDUFA goals. He said there had been concerns about moving to a virtual environment early in the process because getting to a review requires a lot of meetings.
Stein said CDER has internal guidelines that prioritize coronavirus-related work and serious diseases with unmet needs. “So we do have an organized approach if we do have to delay work,” he said, “but I will say so far that we haven’t really had to delay that work.”
CBER director Peter Marks said PDUFA goal dates are largely being met in his Center as well, although some elective but still important programs have necessarily fallen by the wayside during the pandemic.
Marks said he worries about the backlog of clinical trials and how data accrual has been affected by the public health emergency. “I see us having this big bolus in the coming months of vaccines that are going to need approval, and as we clear over Covid-19 I see this pent-up demand for cell and gene therapies, products that have kind of had what I’d almost call stalled development, not the typical stalled development, but stalled because of a pandemic development.”
Marks also said that sponsors and FDA will have to work together to salvage what is possible from Phase 3 trials. He said evaluating the scenario for each trial will be labor-intensive and likely will have to be done on a trial-by-trial basis. “The post-Covid world is going to be very busy,” Marks said, “and it may be as or more busy than the pre-Covid world for a while.”
Stein said CDER also is thinking about issues as trial data come in. “We’re working now on thinking about providing input and guidance on how to manage these impacts,” he said. “And all I can say is at the end of the day we certainly recognize the impacts, and we can’t change our substantial evidence standard. But we can be sensible and flexible about how it’s applied and the kind of information that we’re looking at, and try to be, again, as sensible as possible.”