Tuesday, February 2, 2010

Pharmalot Notes That FDA Warning Letters Doubled In 2009 v. 2008


More importantly, FDA is presently on a pace to issue 48 letters in 2010. This is surely a sign that government is finally-returning to its role -- as a responsible arbiter of regulatory matters, courtesy Ed, at Pharmalot:

. . . .The number of FDA warnings issued for questionable promotions has nearly doubled since President Obama took office. The agency sent 41 enforcement letters in 2009, up from 21 in 2008, according to Tom Abrams, who heads the agency’s Division of Drug Marketing, Advertising and Communications. Meanwhile, nine letters were sent just last month. . . .

Indeed. And while some commenters see April 2009's 14 letters in one day as an "anomaly", I do not. That was serving notice to paid search companies, and there will be more like it in 2010. This -- 40 to 60 per year -- is probably the "new normal".

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