Warning and NOV Letter Summary – 1st Quarter 2015

In the years past when the Office of Prescription Drug Promotion (OPDP) issued Warning Letters (WL) and Notice of Violation (NOV) letters with regularity, it was the custom here at Eye on FDA to review them on a quarterly basis. In particular, it was prudent to look for any evolution of thought with respect to enforcement matters, particularly regarding social media since the agency was dragging its feet in producing any guidance.

Last year however, OPDP produced so few letters that quarterly updates did not seem worthwhile. During the first quarter of 2015, the agency produced only three – not a bumper crop, but worth looking at nonetheless.

As noted in a previous posting (Is Bigger Safer, OPDP Enforcement Patterns and Company Size), recent letters were not aimed at large, well-known companies and in fact, that has been one of the most notable trends in enforcement in recent months.

The three letters from this quarter addressed three communications vehicles – one involving a video and two involving web sites. All three were NOVs and so this quarter so no WLs issued and there was no commonality in the therapeutic purpose of any of the products.

During the first quarter of 2015, not only were there few letters, there were few violations cited within these letters. Many times a letter will contain multiple violations, but this quarter the three letters cite  a total of only seven violations. During the first quarter of 2014, OPDP had produced only two letters – also covering seven violations and in 2013 there were only three letters covering nine violations. By contrast, the first quarter of 2012 saw eight letters with nineteen violations.

Also notable was the type of violations – Since tracking and reporting on the letters here at Eye on FDA, the most common violation has consistently and overwhelmingly been the Omission or Minimization of Risk, but this quarter, it was cited only once.

Violations categories and the number of violations from this quarter tracked in the Eye on FDA database include:

  • Omission or Minimization of Risk (1)
  • Superiority Claim
  • Overstatement of Efficacy (1)
  • Unsubstantiated Claim (1)
  • Broadening of Indication
  • Promotion of an Unapproved Use
  • Promotion of an Investigational Compound (1)
  • Other – which is a catchall for less common violations (3) – 2 of which were Omission of Material Fact and 1 of which was Lack of Adequate Directions for Use

Other than the fact that there were so few letters and so few violations, this quarter was also notable for the fact that one letter contained four of the violations. Another notable aspect was the fact that one of the violations was for Promotion of an Investigational Compound, which is a relatively rare violation. In this letter, the agency cited numerous statements made on a web site that stated that the product was “easy and safe” among other things. Finally, the final of the three letters from this quarter provided an example where it the agency cited a company when it emphasized the fact that it was the only synthetic alternative to animal-based products which inferred superiority.

The lack of activity related to enforcement by OPDP unfortunately leaves less insight into the agency’s thinking around evolving issues, particularly in the area of digital media where guidance has been so long in coming and short on substance. Let’s see what the next quarter brings.

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