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# Cell, Gene Therapy Application Backlog Questioned
- URL: https://www.fdaweb.com/cell-gene-therapy-application-backlog-questioned/
- Published: 2023-03-28T12:00:00.000Z
- Updated: 2026-09-14T18:22:19.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154084

Reps. **Brett Guthrie** (R-KY) and **Anna Eshoo** (D-CA), the chair and ranking member of the House Energy and Commerce Committee’s Health Subcommittee, have written to CBER director **Peter Marks** expressing concern about an increase in the number of clinical holds on BLAs for cell and gene therapies. They ask Marks to explain FDA’s process for addressing the holds.

The [letter](https://guthrie.house.gov/news/documentsingle.aspx?DocumentID=387916&ref=fdaweb.com) says that while Guthrie and Eshoo recognize that clinical holds are an important regulatory tool, “they should be used judiciously and appropriately. CBER should not, for example, use clinical holds as a means for FDA to gain additional time to review a clinical protocol…. We are concerned, after hearing from researchers and patients, that CBER seems to be applying holds on some cell and gene therapies for issues that could possibly be resolved through discussions with sponsors without an issuance of a clinical hold.”

The letter asks for responses to seven detailed questions involving the number of clinical holds, the reasons for the holds, the speed with which holds are removed, PDUFA 7 commitments, and new CBER staff to assist with cell and gene therapy review.