A

mid rising complaints that drug makers are exploiting loopholes to win approval of so-called orphan drugs, the Food and Drug Administration plans to close at least one of them.

In a blog post, FDA Commissioner Scott Gottlieb acknowledged concerns that the Orphan Drug Act, which allows the agency to approve medicines for treating rare diseases affecting fewer than 200,000 people, needs fixing. As he put it, some drug makers are using orphan designations “as a way to sidestep other important public health goals set out by Congress.”

This is a STAT Plus article and you can unlock it by subscribing to STAT Plus today. It's easy! Your first 30 days are free and if you don't enjoy your subscription you can cancel any time.
Already a subscriber? Log in here.

Leave a Comment

Please enter your name.
Please enter a comment.

Sign up for our Morning Rounds newsletter

Your daily dose of news in health and medicine.