Warning and NOV Letter Summary – 3rd Quarter 2013

Government shut down or no government shut down, the read for Warning and NOV letters out of the Office of Prescription Drug Promotion (OPDP) is slim pickings.

It is always a good idea at the end of the quarter to wait several days before doing the quarterly look-back because many times the agency posts the letters to the Web site several days after the date they were sent.  Since the shut down started at the beginning of October, that means that there could potentially be a posting that would involve letters from September.  But I’m going to take my chances and provide the look-back on what has been posted.

And that isn’t much.  FDA’s Office of Prescription Drug Promotion (OPDP) posted a total of three letters during the third quarter of 2013.  At an annualized rate that would mean that we would see a total of perhaps 17 letters this year, the lowest rate of any year since 1997 as near I can tell.  The chart contains 2013 numbers that are projected based on the rate of issuance so far this year.

Of the three letters from this quarter:

  • 1 was a Warning Letter and 2 were Notice of Violation (NOV) letters;
  • 1 letter involved an oncology product, one a product for MS and 1 was dermatological;
  • 2 letters involved drugs with boxed warnings;
  • There were 4 communications vehicles involved in the violations – 2 digital – a Webpage and a banner ad,  and 2 non-digital – a Sales Aid and a DTC print ad

These letters involved a total of 10 violations, and here is how they stacked out:

  • 3 Minimization or Omission of Risk Information
  • 1 Superiority Claim
  • 2 Overstatement of Efficacy
  • 1 Unsubstantiated Claim
  • 3 Other – including a Failure to Submit, Omission of Material Fact and a Misleading Claim

Lessons learned.  Amazingly, two of the letters involving omission of risk information were just that – omission of any risk information.  One, a print ad, failed to have any.  Another – a web page with banners had a link to full prescribing information which was demonstrated not to be sufficient back in 2009 when OPDP (then DDMAC) issued 14 letters regarding banner ads that made clear the agency did not accept links to risk information.

Once the government shut down is over, are we likely to see a recovery in the rate of letters?  There are a few factors to consider.  First, the slowdown in OPDP letters occurred way before the government shut down.  Despite the fact that these letters, along with guidance documents, are one of the few ways to gain insight into agency thinking, letters have simply not been forthcoming.  Second, OPDP does more than produce these letters – they review materials submitted by companies and there are thousands of pieces to review.  Third, presumably no one has been reviewing those pieces which means that when the government does return to some functional status, there may be a backlog to wade through.

Therefore, despite the fact that I have seen some communications materials that have surprised me, I would not to expect much of an uptick in the coming weeks or even months, perhaps making this the slowest year for regulatory action letters from FDA in many years.

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