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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’ Zolgensma, costs $2.1 million, the most expensive drug in history.


While the FDA is quick to insist it has no role in regulating individual drug prices, a top FDA official told STAT Tuesday that he hopes the new policies, which include detailed guides on topics like how to maintain consistent manufacturing standards, will make it easier for drug makers to bring their gene therapies to market. He hopes that will eventually stimulate price competition among drug makers.

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