STAT+: Differences in countries’ regulations keep some cell and gene therapies from reaching patients

CARLSBAD, Calif. — Biotech companies developing cutting-edge cell and gene therapies often are tripped up by how much regulations around these drugs vary from country to country. On Wednesday, regulators from the United States, the European Union, and Japan came together to discuss the scale of the problem — and possible solutions.

It’s a wonky-sounding issue with real-world consequences. In some cases, companies developing therapies they hoped to market globally have shut down entire programs once they realized that meeting U.S. standards wouldn’t be enough for other regions, according to Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research. He added that the FDA has seen this happen multiple times — though he didn’t provide names.

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