Opinion: The next FDA commissioner must be a champion for gene therapies

IGT Chairman Erik Paulsen in BioSpace

The FDA must provide consistent and predictable regulatory frameworks if the U.S. is to maintain its leadership in gene therapy, one of the most consequential therapeutic fields of our generation.

The resignation of FDA Commissioner Marty Makary on May 12 was the latest disruption in what has been a difficult period for the rare disease and gene therapy communities. For families living with devastating genetic conditions, and for innovators working to develop these transformative therapies, it is one more reminder that predictability at the FDA is not a bureaucratic nicety. It is a lifeline...

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