Gene Therapy Explosion Has FDA’s Tiniest Office Plotting Growth

A small office within the Food and Drug Administration is bracing to keep up with a rapidly growing demand for approval of new gene therapies. The Center for Biologics Evaluation and Research must double in size in the next few years so applications don’t pile up, its director says.

Booming Business: Applications for approvals of new cell and gene therapies doubled between 2017 and 2018, and the market is expected to grow to $35.4 billion by 2026. Inadequate staffing at the FDA will delay consumers from getting cutting-edge treatments, Director Peter Marks said.

Fee Hikes Expected: The center gets part ...