FDA Warning V. Untitled Letters: The Difference, as Explained Through The Big Lebowski

Yes, we’re back to the regulatory side of pharmaceutical public relations. Behind all of the enjoyment we get out of developing strategies, creating fascinating multimedia content, targeting distribution, and measuring performance, there are the compliance issues. Regulatory matters are interwoven in the fabric of our efforts, and we know the importance of working closely with the legal department to avoid problems…


…until the FDA comes knocking. Then, healthcare comms want nothing to do regulatory. It’s common to hear:


  • The damage is already done – what can I possibly do now?
  • I don’t have a legal background – how would I be of any help?
  • I don’t even know the difference between an FDA Warning Letter and Untitled Letter – do you really expect me to respond?


Your legal team would likely agree with these concerns, and answer “Nothing,” “You Can’t,” and, “No.”


But what you can do – and what we’ve tried to impress upon pharma PR execs through our regulatory series – is gain a general understanding of the basic compliance issues. We’ve pointed out how to properly balance risks and benefits, correcting third party misinformation, and how to use character-limited social media platforms.


Now, we’re going to explain the difference between a Warning Letter and Untitled Letter when issued by the FDA in the pharma marketing space. So you can appreciate what the legal pros do, even as they’re engaging in their CAPA strategy: Corrective and Preventative Action. Here’s what you need to know.


FDA Warning Letter: “This noncompliance will not stand!”


This is the FDA getting more serious about what your firm has done. The Warning Letter tells you that your content violates regulatory provisions, which the agency has documented noncompliance during its routine inspections and investigations. Maybe your visuals are distracting. You may have not included enough about the risks when talking about benefits of a drug. Or, perhaps your spokes-reality-show-person went a little too far in making claims about your product.


No matter how you …ahem, “earned” the Warning Letter, it’s the FDA’s way of saying: “Hey, this is a matter of regulatory significance, man. There are rules here. This may actually lead to an enforcement action if not corrected post haste!!”


Our variations on The Big Lebowski quotes to make regulatory more interesting notwithstanding, the Warning Letter is your chance to voluntarily comply, i.e., go all CAPA to get back in the FDA’s good graces. The agency’s Regulatory Procedures Manual, Chapter 4 on Advisory Actions makes this point…in oh-so-many words.


Untitled Letter: “Careful, man! There’s an issue here!”


Here, the FDA is pointing out certain violations that aren’t so serious as to warrant a Warning Letter, but they’re still kind of a big deal. There’s no statement that the agency will take enforcement action if your firm doesn’t do some CAPA, there won’t be a follow up, and you won’t see a mandatory request for a written response. The Untitled Letter is saying that a correction is necessary, but it stops short of telling you that the FDA will take action if you don’t change your tune.


According to the Regulatory Procedures Manual, the Untitled Letter is intended to communicate with the pharmaceuticals industry that there may be a violation, but it doesn’t meet the threshold of regulatory significance. Still, in the spirit of The Dude, an appropriate response is NOT: “Yeah, well, you know, that’s just, like, your opinion, man.”


So, what to do when you get either? Yes, leave it to the lawyers. But, armed with this knowledge, you can help your legal department by nipping issues in the bud before the FDA takes notice.

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