Photo of Bexis

We never know what will happen when we post something. Earlier this week we tossed up a short post about a case involving FDA warning letters – at least that’s what we thought.
What we got back was a rip-roaring comment from the attorney for the plaintiff in the case, Regenerative Sciences, Inc. v. FDA, 2010 WL 1258010 (D. Colo. March 26, 2010).  Her beef was, dammit, the case didn’t involve an FDA warning letter, but rather an untitled letter, and you guys are smart enough to know better.  But we’ll let Kelly Lightfoot smack us down in her own words:

In Regenerative Sciences, Inc. v. FDA, the FDA did not issue a Warning Letter to Regenerative Sciences, Inc. (“RSI”).  The FDA sent an Untitled Letter.  As regulatory counsel, we all understand there is a significant difference between these two types of letters.  You understand this distinction, as well, as you blogged about it on August 14, 2007 in your post titled “Untitled (As In “Untitled Letters”).  The Untitled Letter is used by the Agency when the Agency is uncertain about an issue and when the Agency does not know if there has been an actual violation.  The Warning Letter is issued for actual violations that may lead to Agency enforcement if not corrected.  In the case of RSI, the Untitled Letter is merely a low-level communication expressing the Agency’s stance on the practice of medicine and use of autologous stem cells. It is not proof of any wrongdoing by RSI.

She’s right, you know – well, in part.
But honest, officer, it wasn’t our fault.
Blame it on the judge – we do.
Our excuse is that the court in Regenerative Sciences, twice in the opinion, called the FDA correspondence at issue a “warning letter.”  2010 WL 1258010, at *7 (“the July 25, 2008, FDA warning letter”); id. (“Regenerative has already received a warning letter from the FDA on July 28, 2008”).  We only know what we read, and reading this opinion, we thought – with justification, we add – that it was a warning letter case.
But if even a judge can get this wrong….
Hey, that means it’s probably a good topic for a longer post, so here goes.
First of all – everybody knows that the FDA issues warning (and other) letters.  But since it’s an administrative agency, Congress had to give it the power to do that.  Here’s where that power comes from: The Food, Drug and Cosmetic Act (“FDCA”) expressly gives the FDA authority to address “minor violations . . . by suitable written notice or warning.”  21 U.S.C. §336.  Hence, point number one; if the FDA is content to address some possible violation by letter, by definition it’s a “minor violation.”  It has to be, otherwise, by statute, the FDA has to resort to some other enforcement tool.
Now, for the letters themselves. The FDA issues lots of kinds of letters – there are closure letters, acknowledgement letters, REMS letters, NIDPOE letters, recall letters, and the letters formerly known as “approvable” or “not approvable.”  But the FDA letters we usually encounter in litigation are one of three types:  (1) “warning” letters; (2) “untitled” letters, and (3) “advisory” letters.  So those three are all we’re discussing today – three, no more, no less. Three shall be the number, and the number of the counting shall be three.

Warning Letters

We’ll start with warning letters, which are the most serious of the lot.  But even a warning letter is not any form of FDA enforcement action.  Instead, as the FDA reiterated in its brand, spanking new “Regulatory Procedures Manual” only a few weeks ago (it’s dated March 2010); a warning letter is but a prelude to possible enforcement.  Instead of enforcement, a warning letter is intended to bring about voluntary compliance:

[I]t is the Food and Drug Administration’s (FDA’s) practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice.

FDA Regulatory Procedures Manual §4.1.1 (“Warning Letters”), at p. 4-1.  Warning letters “are based on the expectation that most individuals and firms will voluntarily comply.”  Id.
Thus – and this was the point we were making in the earlier post about the Regenerative Sciences case – the FDA does not consider a warning letter to be any form of final agency action:

A Warning Letter is informal and advisory. It communicates the agency’s position on a matter, but it does not commit FDA to taking enforcement action. For these reasons, FDA does not consider Warning Letters to be final agency action.

Id. §4.1.1 at p. 4-2.  Now, the FDA does this for its own somewhat nefarious reasons, specifically because it doesn’t want to get sued over what it puts in warning letters.  But, as we’ll get into, leaving things with warning letters tentative and up in the air like this does, and should, have consequences for the admissibility of these letters in civil litigation.
Another thing that the FDA’s Regulatory Procedures Manual makes pretty clear is that warning letters are “not appropriate” if alleged violations are “repeated,” “continual,” “intentional,” “flagrant,” or “willful”; or if “[t]he violation presents a reasonable possibility of injury or death.”  Id. §4.1.1 at pp. 4-2 to -3.  What does that do for us?  Well, it means essentially that FDA warning letters shouldn’t have any significance in a punitive damages case.  That’s because punitive damages generally are only available where the defendant’s conduct is all of the things that the FDA says aren’t properly addressed in warning letters.

Untitled Letters

The next category is the “untitled” letter.  An untitled letter is even less than a warning letter.  “An Untitled Letter cites violations that do not meet the threshold of regulatory significance for a Warning Letter.”  FDA Regulatory Procedures Manual §4.2.1, at p. 4-26.  Thus, among other things, an untitled letter “does not include a warning statement that failure to take prompt correction may result in enforcement action.”  Id. at p. 4-27. That’s pretty much all the FDA has to say about untitled letters.
An untitled letter of this sort is what Ms. Lightfoot told us was actually at issue in Regenerative Sciences.

Advisory Letters

Finally, the FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) also has (or possibly “had,” since we’ve only encountered these letters in a pre-FDAAA context) a program that lets manufacturers send in samples of proposed advertising for evaluation before the ads are ever shown.  DDMAC’s evaluations are contained in “Launch Campaign Advisory Letters,” which we just call “advisory letters.”  The DDMAC program is/was voluntary, so it’s not even included in the FDA’s Regulatory Procedures Manual.
We did find DDMAC advisory letters discussed in the FDA’s “2007 Report to the Nation: Improving Public Health Through Human Drugs.” The FDA describes this program as:

When requested, we review advertisements and other promotional materials before drug companies launch marketing campaigns that introduce new drugs or new indications or dosages for approved drugs.  In 2007, we issued 129 advisory letters to companies regarding their promotional materials for launch campaigns.

Id. at 44.
Yeah, yeah, we know – you can’t very well cite us in a brief, although we’ve been cited in law review articles.  Sad to say, we don’t know of any case (if we’re wrong, tell us) where what we’ve just discussed is discussed in any organized fashion – save one.  There’s a pretty good discussion of the various types of FDA letters in Bailey v. Wyeth Inc., 2008 WL 2856146 (N.J. Super. July 11, 2008).  Unfortunately, Bailey is a really long opinion, and Westlaw doesn’t deign to put page citations on what it calls “trial orders,” so you’ll have to hunt for it – or else cite the Lexis version (2008 N.J. Super. Unpub. Lexis 3004).
As we mentioned in the earlier post, our opponents practically drool at the sight of FDA warning and other letters – since they’re usually critical of one aspect or another of our clients’ marketing activity.  So when the other side’s not busy denying that anything the FDA does is mandatory (when it comes to opposing preemption), they’re busy waving these letters around as if they’re conclusive proof that we did something wrong and should have to pay gazillions of dollars.
We, of course, say that’s crock.
But what do courts say?
Well, the courts are pretty near unanimous in holding that warning and untitled letters aren’t “final” in any meaningful sense.  FDA “letters are not final agency action . . ., as there has been no final agency action, let alone action that has been or could be judicially reviewed.”  Schering-Plough Healthcare Products, Inc. v. Schwarz Pharma, Inc., 586 F.3d 500, 508 (7th Cir. 2009) (affirming a nice discussion at 547 F. Supp.2d 939, 946-47).  “[T]he type of informal letter issued by the FDA . . . does not constitute . . . formal or final agency action.”  Dietary Supplemental Coalition, Inc. v. Sullivan, 978 F.2d 560, 562-63 (9th Cir. 1992).  Such letters are “informal communications.”  Professionals & Patients for Customized Care v. Shalala, 56 F.3d 592, 599 (5th Cir. 1995).  “Warning letters merely establish a dialogue between the FDA and the [addressee] and do not necessarily lead to further sanctions.”  Biotics Research Corp. v. Heckler, 710 F.2d 1375, 1378 (9th Cir. 1983).
We noticed the Regenerative Sciences case precisely because it labeled them (that is, the untitled letter that the court called a “warning” letter) “tentative and interlocutory.”  2010 WL 1258010, at *7.  Warning “letters do not constitute a final decision by the FDA.”  Perez v. Nidek Co., 657 F. Supp.2d 1156, 1166 (S.D. Cal. 2009).  “[R]egardless of any warning letters that the FDA may have sent . . ., it is clear that the FDA has not completed this investigation.”  Summit Technology, Inc. v. High-Line Medical Instruments Co., 922 F. Supp. 299, 306 (C.D. Cal. 1996).  “It is well-settled . . . that an agency’s investigatory activity does not constitute final agency action.”  Genendo Pharmaceutical N.V. v. Thompson, 308 F. Supp.2d 881, 884 (N.D. Ill. 2003).  Thus, an “FDA letter is insufficient to establish a violation.”  Chan v. Orthologic Corp., 1998 WL 1018624, at *20 (D. Ariz. Feb. 5, 1998).
After issuing a warning letter, and receiving a response, there’s nothing to keep the FDA from deciding that the recipient was either in compliance or took adequate steps to come into compliance, and thus that no enforcement action is ever necessary.  See Summit Technology, Inc. v. High-Line Medical Instruments Co., 933 F. Supp. 918, 934 n.9 (C.D. Cal. 1996) (rejecting plaintiff’s claim that warning letters indicated illegal conduct; “after further review, the FDA could ultimately decide . . . that [the conduct] is entirely legal”).  The FDA’s procedures provide, and precedent uniformly agrees, that its various regulatory letters decide nothing and enforce nothing.
That’s important because most states have rules of evidence equivalent to Fed. R. Evid. 404(6) (“[e]vidence of other crimes, wrongs, or acts is not admissible” except for enumerated exceptions), and Rule 609 (governing when witnesses can be impeached with criminal “convictions”).  Thus, we’re quite sure that in most jurisdictions evidence of mere arrests or indictments for crimes isn’t admissible when there’s been no conviction.
Arrests and convictions are at least the commencement of what we’d say is criminal “enforcement activity.”  But as we hope we’ve made clear in all the stuff you’ve just read, FDA warning, untitled, and advisory letters don’t even reach the level of an arrest or indictment, and aren’t even enforcement activity at all – according to the FDA itself.  They’re more like bureaucratic foreplay.
Because of that, it’s our position that unless and until whatever it is that’s the subject of one of these FDA letters (1) turns into a real enforcement action, and (2) that results in conviction, FDA letters have no business being admitted as evidence in civil trials.
We’ve seen a number of cases that exclude FDA warning and other letters for these types of reasons:  King v. Danek Medical, Inc., 37 S.W.3d 429, 441-42 (Tenn. App. 2000); In re Viagra Products Liability Litigation, 658 F. Supp.2d 950, 966 (D. Minn. 2009); In re Seroquel Products Liability Litigation, 2009 WL 223140, at *4-5 (M.D. Fla. Jan. 30, 2009); Chan, 1998 WL 1018624, at *5; Summit Technology, 933 F. Supp. at 034 n.9.  Similar types of preliminary governmental assessments of possibly violative activity have also been excluded.  See Shoppin’ Bag of Pueblo, Inc. v. Dillon Cos., 783 F.2d 159, 165 (10th Cir. 1986) (FTC investigation of defendant excluded because it was brief and it reached no conclusion about party’s behavior; evidence had little probative value and was highly prejudicial); New York v. Pullman, 662 F.2d 910, 915 (2d Cir. 1981) (non-final agency finding held misleading because it carries “an aura of special reliability and trustworthiness . . . not . . . commensurate with actual reliability”).
Thus, whether it’s an FDA warning, untitled, or advisory letter, the important point is that these are nowhere close to final agency action about anything.  Moreover, as we pointed out here, except between 2001 and 2009, the FDA didn’t even require the legal conclusions in its letters to be reviewed by an actual lawyer before they could be sent.  For these reasons, we don’t think any of these letters should see the light of day in civil litigation.