STAT Plus: With new rules, FDA aims to spark competition, lower prices for expensive gene therapies

WASHINGTON — The Food and Drug Administration released a slew of gene therapy policies Tuesday aimed at encouraging drug makers to bring more of the medicines to market and perhaps forcing them to lower their prices.

The FDA has approved just four gene therapies since 2017, and each has carried a sky-high price tag. The FDA’s most recent approval, AveXis’s Zolgensma, costs $2.1 million, the most expensive drug in history.

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