CBER Will Devote More Time To Non-COVID-19 Work Beginning In Six Months
Executive Summary
Center for Biologics and Evaluation and Research is to resume normal operations at the beginning of 2023 and will stop prioritizing resources for COVID-19 regulatory work over non-COVID-19 matters.
The US Food and Drug Administration’s Center for Biologics Evaluation and Research anticipates the frenetic pace of work centered on the COVID-19 pandemic to slow down over the next few months. As a result, it plans to resume normal operations at the beginning of 2023 and pay more attention to non-COVID-19 matters.
In a 9 June letter to sponsors, applicants and regulated entities, Christopher Joneckis, CBER’s associate director for review management, said the center was updating a letter it issued on 30 April 2020 prioritizing work that advances the nation’s response to the COVID-19 public health emergency.
“The impact of COVID-19 on CBER during the public health emergency has been unprecedented and placed extreme burdens on product development, approval, and surveillance functions,” he stated. “Although COVID-19 workload has been reduced in some areas, there remains substantial COVID-19 regulatory work, especially for vaccines. In addition, CBER’s non-COVID-19 review workload continues to remain substantial, especially in non-COVID-19 vaccines and in cellular and gene therapies.”
“For the remainder of this calendar year, CBER will continue to prioritize resources for COVID-19 regulatory work over non-COVID-19 work, as needed, to respond to the ongoing public health emergency. As we enter calendar year 2023, we plan to resume normal operations,” Joneckis said.
Past Stopgap: Reallocating Staff, Triaging Workload
CBER has noted the difficulties keeping up with non-COVID-19 work during the pandemic. It was already understaffed heading into the pandemic due to increased workload with cell and gene therapy. The heavy COVID-19 workload pushed other things to the side, causing delays in sponsor meetings and issuance of new guidance documents. (Also see "US FDA’s Gene Therapy Work Feeling The Effects Of Pandemic Response" - Pink Sheet, 10 Jun, 2020.)
The center adopted an internal “hierarchy” to prioritize the non-COVID-19 workload, reallocated personnel and received help from other parts of the agency at the outset of the pandemic. (Also see "Gene Therapy May Pack US FDA’s Calendar This Fall; CBER Staffs Up" - Pink Sheet, 23 Apr, 2020.)
CBER also developed a triage process for dealing with some cell and gene therapy submissions. (Also see "CBER Designing Triage System For Gene Therapy Submissions In Lieu Of ‘First In, First Out’ System" - Pink Sheet, 11 Nov, 2021.) This is one of the areas that will likely get increased attention when the center normalizes its operations.
While COVID-19 may require less resources, CBER will still have plenty of work dealing with applications for new vaccine candidates and modifications of vaccines to respond to the emergence of new variants. The FDA’s Vaccines and Related Biological Products Advisory Committee is meeting on 28 June to discuss whether the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified.
In-Person Meetings Remain On Hold
In its April 2020 letter, CBER noted that its in-person meetings were being converted to teleconferences. In the updated letter, Joneckis said all external meetings will remain in virtual format and that CBER will continue to assess the feasibility of holding in-person meetings at FDA facilities. He said sponsors and applicants should monitor CBER’s website for updates about in-person meetings.
He said applicants and sponsors should continue to submit documents in standard eCTD format using the Electronic Submission Gateway.
CBER had paused certain lot release activities and stopped receiving biological product samples or protocols in physical form (paper or CD-ROM) beginning on 23 March 2020. Joneckis said this pause will continue until further notice. In a 17 March 2020 letter to manufacturers, CBER said that in order to continue with the release of new lots whose protocols are in paper or CD-ROM, they should convert their lot release protocol to PDF.
FDA would, of course, like to move beyond PDFs for document handling. (Also see "The Last Days Of PDFs: Industry Works To Solve Its US FDA Application Problem" - Pink Sheet, 1 Jul, 2020.)
CBER is also doing away with the extension of response due dates for device marketing applications. In a 7 June Federal Register notice, the agency announced the withdrawal of the guidance, “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices – Questions and Answers," which was issued in June 2020. The guidance automatically extended applicant response due dates to address many device submission deficiencies. The agency said these policies are no longer needed.