Warning and NOV Letter Summary – 4th Quarter 2011

Each quarter Eye on FDA provides a brief recap of the regulatory action letters issued respecting the promotion of prescription drugs. The office that issues the letter underwent a change during 2011, changing its name in the process from the Division of Drug Marketing, Advertising and Communications (DDMAC) to the Office of Prescription Drug Promotion (OPDP).

First let’s look at the enforcement pattern compared to previous years.  The chart below plots out the number of letters issued each year since 1997.  While enforcement began to creep back up slowly in 2009 and 2010, it appears to have fallen off again.

Moving on to the letters of the fourth quarter themselves… During the first three quarters of the year, OPDP had issued only 21 letters. During the final quarter of 2011, they sent 9 more that covered 24 different cited violations;

  • Minimization/omission of risk information – 9
  • Unsubstantiated Superiority Claim – 4
  • Overstatement of Efficacy -4
  • Unsubstantiated Claims – 2
  • Omission of Material Facts – 1
  • Misleading Claim – 1
  • Inadequate Presentation of Established Name – 1
  • Inadequate Statement of Indication -1
  • Promotion of Unapproved Use -1

The communications vehicles involved included 2 Websites, a rebate card, an exhibit panel, and exhibit booth, 2 sell sheets and oral statements.

While each violation cannot be reviewed, here are a few of the more interesting:

  • The statement that a treatment provided “most relief” was deemed to be a unsubstantiated supriority claim;
  • The phrase “simple, hassle-free use” became an unsubstantiated claim when the PI described a thirteen-step procedure;
  • A booth display that had the indication information on top and the risk information on bottom where it was obscured by bags, boxes and materials was deemed a de facto  omission of risk information.

There were many more, but the risk information issues have always been the most prevalent violation cited in regulatory action letters. As to the number, even with the surge of the last quarter, there is still a decline from the previous year.  There had been some thought that when policy was changed in 2009 that no longer required review by legal counsel of most action letters, that there would be an increase in the level of enforcement, but that does not appear to be the case.

Meanwhile, in 2012, FDA’s OPDP has issued its first letter of the year.

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