2014 Was Another Record Year for FDA: Fewest Number of Untitled/Warning Letters Ever!

In 2014, the FDA approved 41 new drugs -- the most since 1996 (see here). That's quite a "record" even if 37% of the approvals were made in December alone.

But FDA wasn't as anxious to set any advertising enforcement records in 2014. The Agency sent out only a meager 9 Untitled Letters and 1 Warning Letter last year (see chart on left).

Could the reason for this be that pharmaceutical marketers are getting better at complying with FDA regulations?

Or is the FDA afraid of being sued by the pharmaceutical industry in the wake of the 2012 Caronia decision in the U.S. Second Circuit that found off-label promotion was protected by free speech?

Or perhaps FDA depends more and more on "user fees" paid by the drug industry and does not want to "bite the hand that feeds it"?

I think the latter is the most likely explanation. Read on to learn why.

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