WASHINGTON — Somewhere in the depths of the Food and Drug Administration, applications for 4,300 generic drugs are awaiting approval.
With growing dissatisfaction over the price of prescription drugs, that backlog has become more than a bureaucratic curiosity. Congress is furious. Hillary Clinton has raised the issue on the campaign trail. And drug makers are threatening to abandon the generics business altogether if the FDA doesn’t speed things up.
The FDA, for its part, blames drug makers for sloppy and incomplete applications that slow the process.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
To submit a correction request, please visit our Contact Us page.