Life Sciences

FDA sending out fewer warning letters

Pharma Compliance Alert, June 11, 2008

The number of warning letters sent by the FDA dropped by more than half in the past seven years, according to a Dow Jones Newswire article.
 
In 2001, the FDA sent 1,032 warning letters, but in 2007, that number dropped to 471. The agency said the decline in warning letters was due to a policy change requiring all warning letters to go through the agency’s chief counsel’s office, according the article.
 
FDA commissioner Andrew von Eschenbach said the number of warning letters decreased because the agency now only sends them out for serious violations, according to the article.
 
While the number of warning letters decreased, the number of recalls increased. From 1996 to 2000, the agency recalled an average of 3,500 products annually. From 2001 to 2006, that average rose to 4,700 a year.

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