FDA chief says he’s open to rethinking incentives on orphan drugs

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 this 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.”

Gottlieb said it’s time to ask the question: “Do we have the right incentives in place?”

The nearly 35-year-old law created incentives for companies to develop “orphan because they treat rare diseases affecting fewer than 200,000 people. Those incentives include a waive on millions of dollars in fees, seven years of market exclusivity and a tax break for research and development expenses.