This is the second of two stories on monitoring the safety of new drugs — read the first here


ASHINGTON — In 2007, after a number of dangerous medicines were pulled off the market, Congress ordered the Food and Drug Administration to set up an early warning system to detect other harmful drugs before more people died.

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.

  • Perhaps if drug labels and information sheets were required to include a link to the Medwatcher app, more patients would self-report concerning side effects. This easy to use app was developed to report adverse events to FDA for drugs and for medical devices, and can be found at

  • Perhaps it is time to go back to scientific data testing of “new” or “improved” drugs BEFORE they go on the market.

Sign up for our Biotech newsletter — The Readout

Your daily guide to what’s new in biotech.