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WASHINGTON, D.C. – Congressman Brett Guthrie (KY-02) and Congresswoman Anna Eshoo (CA-16), who serve as the Chair and Ranking Member, respectively, of the House Energy and Commerce Committee Subcommittee on Health, sent a letter to Dr. Peter Marks, the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA), on the backlog of cell and gene therapy applications.

Specifically, the Members raise concerns on the increase in the number of clinical holds of biologics license applications (BLAs) for cell and gene therapies and inquire about the FDA’s process for addressing these holds.

“We write to you today to inquire about the Center for Biologics Evaluation and Research’s (CBER) recent efforts to address the growing number of biologics license applications for cell and gene therapies and to raise concerns about the increase of clinical holds the Food and Drug Administration (FDA) has recently issued delaying a proposed clinical investigation or suspending an ongoing investigation for such products,” wrote Guthrie and Eshoo.

“We hope CBER continues building off past accomplishments in the cell and gene therapy space to advance the number of approvals even higher. Furthermore, we encourage the FDA to use its regulatory discretion where necessary to make these innovative products available to patients in need, particularly those with ultra-rare or fatal diseases or for whom there are limited or no treatment options,” the members continued.

The Members ask FDA questions to better understand how CBER is working to address the challenges to get more novel therapies to patients. Click HERE to read the questions and the full letter.

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