Friday, September 17, 2010

FDA "Deceptive Promotion" Warning Letters To Triple: 2008 to 2010

Back in February 2010, I guessed that FDA would issue between 40 and 60 warning letters concerning allegedly deceptive drug promotions in all of 2010. That number would have either (depending on whether FDA reached the bottom, or top of the range) doubled, or tripled the number issued in 2008 (the last year of the disastrous Bush-Cheney administration).

We can now report that 2010's letter tally will likely be near the top of the range. Given that -- through mid-September 2010 -- FDA has already sent 45 letters, 60 looks to be the likely year-long grand total. So, I've revised the graphic (at right). It is certain there are plenty of questionable promotions underway.

Today's updated figures via Reuters; and Pharmamlot's original February 2010 quote:

. . . .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. . . .

Back in February, some commenters suggested that April 2009's 14 letters in one day was an "anomaly". It clearly was not. The April bolus served as a "wake-up call" to the industry. This -- 40 to 60 per year -- is probably the "new normal". And it is just as surely a sign that government has returned to its role -- as a responsible arbiter of regulatory matters -- not a rubber-stamp for industry.

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