May 20, 2015
I want a new drug (adverse event reporting system)
The Adverse Event Reporting System used by the U.S. Food and Drug Administration is known to be incomplete. Still, it’s often the best source of information to assess a drug’s safety it is on the market. So, how incomplete is the data?
The last time the GAO did a comprehensive review of the data, in 2000, it estimated fewer than 10% of all incidents are reported to the FDA.
The Slippery Slope: Adverse Events and Runaway Diabetes Train MedPage Today (Dec. 22 2014)