FDA warning letters rise 78% over six years with increase expected in 2015

The number of warning letters sent by the US Food and Drug Administration increased substantially by 78% from 2007 to 2013, with pharma and biotech companies accounting for one of the highest number of warning letters.

Research from Sparta Systems analyzed FDA warning letter trends since 2007. It found that the average growth rate for warning letters issued between 2007 and 2012 was 15.8% per year. The issuing of FDA warning letters increased 78% from 2007 to 2013, even with a 12.4% decrease from 2012 to 2014.

It speculated that the decrease between 2012 and June 30 this year was due to fewer FDA inspections as a result of reduced funding for the FDA and an industry-wide freeze on manufacturers’ FDA fees.