The FDA is trying to make gene therapy companies compete
The rise of gene therapy promises one-time treatments for devastating diseases. It also threatens payer budgets with seven-figure price tags. Now the FDA, powerless to actually regulate drug prices, is trying to clear the way for competition that might make gene therapy more affordable.
As STAT’s Nicholas Florko reports, the agency finalized a slew of new policies yesterday with the goal of streamlining the process of getting a gene therapy approved. That means standardizing the rules on manufacturing and, perhaps most important, determining whether competing gene therapies qualify for FDA special treatment.
“We’re very acutely aware that if we want to see [gene therapies] come to benefit more patients were going to have to see the price come down,” Peter Marks, the director of FDA’s biologics center, told STAT. “And towards that end, that’s why we want to do we can to float all boats.”
Read more.
As STAT’s Nicholas Florko reports, the agency finalized a slew of new policies yesterday with the goal of streamlining the process of getting a gene therapy approved. That means standardizing the rules on manufacturing and, perhaps most important, determining whether competing gene therapies qualify for FDA special treatment.
“We’re very acutely aware that if we want to see [gene therapies] come to benefit more patients were going to have to see the price come down,” Peter Marks, the director of FDA’s biologics center, told STAT. “And towards that end, that’s why we want to do we can to float all boats.”
Read more.
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