DDMAC enforcement letters skyrocket

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As new resources come into FDA's Division of Drug Marketing, Advertising and Commissions, it reports that it has exceeded last year's totals for issuing warning and untitled letters sent to pharmaceutical marketers for violating agency advertising and promotion regulations.

Through August 30, according to division director Thomas Abrams, it had sent 45 such letters, four more than the total for 2009 and comfortably more than double the 21 sent the year before.

The increase is a continuation of FDA commissioner Margaret Hamburg's enforcement escalation initiative that she ordered a year ago, Abrams said.

The most common violations cited by the agency are: omission and minimization of risk information, unsubstantiated claims of efficacy or safety, unsubstantiated comparative claims, promotion of unapproved uses of drugs. The number of promotional pieces submitted to DDMAC last year spiked 8% to 76,631, according to DDMAC staff. The percentage increase was twice as high from 2008 when there was a 4% increase.
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