Brigid Bondoc spoke to Genomeweb about the head of the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research expressing a desire to shepherd more gene therapies for rare diseases to market through the accelerated approval pathway.
"Understanding [the FDA's] long-term safety monitoring expectations is something that the field has always struggled with," Brigid said. But this is precisely the promise of gene therapies, which are expected to have long-term, durable, and curative benefits. These therapies could, theoretically, be on the market for many years before confirmatory data are available, which Brigid noted is a common criticism of the accelerated approval pathway.
Brigid added: "[The FDA] will be under a lot of pressure to approve the therapies, but public trust is also on the line. I don't envy the position that they're in."
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