While Gottlieb can change agency guidelines, any change to the Orphan Drug Act’s incentives would require congressional action. (Photo: Shutterstock)

The commissioner of the Food and Drug Administration questions whether the right financial incentives are in place for drugmakers who develop orphan drugs for rare diseases.

In an interview last week, the FDA’s Scott Gottlieb said the Orphan Drug Act of 1983 has provided “an enormous amount of public health value” over the years, but the “market has changed.”

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