Warning Letter and NOV Summary – 2nd Quarter 2011

There has been a lot of commentary about the pick up in enforcement actions by FDA and on the whole, it may be true.  But looking at the Division of Drug Advertising, Marketing and Communications (DDMAC), the increase is not as robust as it once appeared.

This is due partially to the 2009 hiccup of 14 regulatory letters issued in a single day regarding a single topic.  That move served as an anomaly, artificially bumping up the number for 2009.  While the numbers overall since 2008 have increased, the level of enforcement is not nearly what it was during the Clinton Administration.  In fact, if the trend of the second half of the year keeps pace with the first half, then DDMAC will have sent only 34 letters this year, below the level of the past two years.

For the 2011 year, during the first quarter there were only 5 letters while in the second quarter there were 12.  Also for the year, there were 39 different violations cited in the letters, 28 of which were in the last 12 letters of the second quarter.

Each letter usually cites more than one violation and the lack of risk information, or the minimization of risk, is consistently the most frequent issue for DDMAC with promotional materials.  The violations for the second quarter were:

• 9 Risk Minimization or Omission of Risk Information
• 2 Superiority Claims
• 3 Overstatement of Efficacy
• 4 Unsubstantiated Claims
• 4 Broadening of Indication
• 8 Other

It was noteworthy that for the “other” category, there were two instances of pre-approval promotion – a relatively rare violation in the past.

The vehicles for the violations were primarily non-digital and none were social media based (the video was on YouTube, but the violation was not connected with that fact) and included:

• Journal Ad
• Professional Sales Aid
• Oral Statements by a Sales Representative
• Brochure
• Video
• A Magnet
• Flash Card (2)
• Leave-Behind Detail Aid
• Website (2)

There were 11 NOV letters and only 1 Warning Letter, totaling for the year 14 NOVs and 3 Warning Letters.