Tuesday, August 14, 2007

Untitled (As In "Untitled Letters")

You know what ticks us off?

(Regular readers of this blog know that that's a rhetorical question: Plainly, everything ticks us off.)

Well, what's ticking us off today, then?

First, there's a news report that the FDA sent a nastygram to a drug company -- a letter raising an issue about the company's promotional materials. Here's a link to CNN's coverage of a letter the FDA sent to Pfizer last month, but just posted on the FDA website yesterday. The FDA's letter criticizes materials used to promote the schizophrenia drug Geodon. And the headline, of course, screams that "FDA Accuses Pfizer of False Advertising."

Others pick up the story. All of a sudden, the FDA has sent a "Warning Letter," which sounds like it's a big deal.

And, as sure as we're sitting here, if Pfizer is ever sued in a product liability case about an alleged side effect of Geodon, plaintiff will offer this letter into evidence as supposed proof that Pfizer did something wrong.

Slow down.

This communication from the FDA is not a "Warning Letter." It's an "Untitled Letter." An untitled letter is "initial correspondence . . . that cites violations that do not meet the threshold" for issuing a more serious "warning letter." FDA Regulatory Procedures Manual, Ch. 4, Advisory Actions 4-27 (2006) (available on-line here). An untitled letter does not "demand" that the manufacturer stop using the questioned material; it only "requests" a response. An untitled letter typically does not ask a manufacturer to take "corrective action" by publishing new ads to offset the effect of the old, supposedly misleading ones. And an untitled letter is far from proof that the manufacturer did anything wrong; it is simply the lowest-level communication from the FDA suggesting that someone at the FDA thinks the manufacturer may have dome something wrong.

If the FDA were ever to run that allegation up its internal flagpole -- to elevate the accusation even to a "Warning Letter," let alone to some type of enforcement action, others within the agency might choose not to proceed. And, even if the FDA chose to proceed, a court could hold that the FDA was wrong, and the promotional materials were entirely proper.

These issues rarely go to court, of course, because a manufacturer would be nuts to pick this type of fight with the FDA. But courts should be sensitive to two things: (1) the regulatory insignificance of "Untitled Letters," and (2) the undue weight a lay jury might accord an untitled letter if it were admitted into evidence.

"Untitled Letters" should almost never be admitted into evidence. If relevant to any issue at all, their prejudicial effect surely outweight their probative value.

We hope that both defense counsel and courts will keep that point in mind.

1 comment:

Anonymous said...

I was searching for the definition of an untitled letter, and I found your very excellent explanation.

Good work and THANKS!