The agency has approved just four gene therapy drugs since 2017 and each has been very expensive. Novartis’ gene therapy, Zolgensma, is priced at $2.1 million and is the world’s most expensive drug.
The FDA can’t regulate drug prices, but an agency official told STAT he hopes the new policies will stimulate price competition among drugmakers.
“We’re very acutely aware that if we want to see [gene therapies] come to benefit more patients we’re going to have to see the price come down,” Peter Marks, MD, director of the FDA’s biologics center, told STAT.
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