The new, no-longer-draft, Guidance can be found here. If you’re willing to pay, it’s also on Westlaw, at 2009 WLNR 664485. The Federal Register statement that accompanied the guidance is at 74 Fed. Reg. 1694 (FDA Jan. 13, 2009).
When we first heard about this a couple of days ago, we thought about preparing a grand, definitive work on what the FDA did. But that’s really administrative law, and that’s not really our thing. Not only that, there’s only two of us. Over at the FDA Blog they can draw on a whole firm of FDA specialists; and Reed Smith’s got 150 potential blog contributors in their health/products group. So we decided to leave that kind of grunt work to those guys – and you know what? They’ve come through, here and here. So if you want the particulars of each and every little regulatory hoop the FDA has set up, see ya.
Well, there’s that, and the fact that we were busy and couldn’t get around to it until now, so they basically scooped us. Hey, we’re lawyers, we can rationalize anything.
But we’re also litigators, and it’s through that perspective that we view the Guidance.
The most important thing we see in the Guidance right is the dichotomy between the FDA’s legal justification for its off-label promotion ban, and the agency's policy reasons for the new exception, which follow immediately afterwards. The two don’t fit together very well.
The FDA’s legal justification for the ban is absolutist – having nothing whatever to do either with the truth of the information, or with the safety of the off-label use involved. Take a look:
[T]he FD&C Act and FDA’s implementing regulations generally prohibit manufacturers of new drugs or medical devices from distributing products in interstate commerce for any intended use that FDA has not approved as safe and effective or cleared through a substantial equivalence determination. The Agency recognizes the value of having new indications and intended uses for products approved or cleared by FDA and encourages sponsors of medical products to seek such approvals or clearances. An approved new drug that is marketed for an unapproved use is an unapproved new drug with respect to that use. An approved drug that is marketed for an unapproved use (whether in labeling or not) is misbranded because the labeling of such drug does not include "adequate directions for use" Similarly, a medical device that is promoted for a use that has not been approved or cleared by FDA is adulterated and misbranded.
Guidance, at “Purpose” (don't blame us for the lack of page numbers).
This analysis confirms what we’ve said before about the FDA’s prohibition of off-label promotion not distinguishing in the slightest between truthful and untruthful speech – and not only that, the FDA's ban applies without regard to whether the information would benefit or harm the public health.
Since we’re litigators, not regulators, we find that interesting in two respects. First, we know we sound like a broken record, but the law’s failure to distinguish between truthful and untruthful speech makes the ban subject to First Amendment challenge. And since it doesn't turn on safety either, its rationale looks weaker every day. In short, the First Amendment requires that truth be a defense to an off-label promotion claim because blanket government suppression of truthful speech is unconstitutional. When all else fails, defendants have the First Amendment defense to fall back on.
Second, we don’t have to wait for all else to fail. That the FDA’s ban on off-label promotion turns on neither truth nor safety is critical to whether private plaintiffs being able to bring suit in the first place – whether such suits sound in product liability, RICO, false claims, or anything else. That’s because the FDCA, in 21 U.S.C. §337(a) prohibits private enforcement of violation claims. FDCA enforcement, as we’ve discussed several times before, is solely a government responsibility.
But what about parallel claims or negligence per se?
What about them? A single line can’t be “parallel.” There must be some pre-existing state-law duty for a violation claim to track, otherwise there’s nothing more than a naked FDCA violation barred by §337(a):
[F]or an FDCA violation to be “parallel” to a state law claim of any sort, a traditional state tort duty must actually exist. There must be something for the asserted FDCA violation to be “parallel” to.
More Thoughts on “Parallel” Requirements. Hey! Other people quote us, so we can quote ourselves every now and then.
If you don’t believe us, the recent Sprint Fidelis decision took a page right out of our book (blog?) when it said essentially the same thing while addressing negligence per se:
A claim of negligence per se simply adopts the standard of care imposed by a statute or regulation as the standard against which the defendant's conduct is evaluated. Stated differently, negligence is the breach of a legal duty, and under a negligence per se theory, the measure of that legal duty comes from a statute. . . . With this understanding of the foundations for negligence per se, it becomes clear why it cannot apply here. The negligence per se doctrine is not a magic transforming formula that automatically creates a private right of action for the civil enforcement, in tort law, of every statute.
2009 WL 35467, at *13 (citation and quotation marks omitted). No matter how you approach the problem, there’s gotta be an underlying tort, or else the claim fails under §337(a).
But since the FDA’s off-label promotion ban doesn’t turn on safety, that means there’s no plausible state-law cognate in the product liability field to provide the “parallel” for a private violation claim. That means that a suit alleging “illegal promotion” because a manufacturer of an FDA-regulated product allegedly promoted an off-label use doesn’t belong in a product liability action.
Ditto for the off-label promotion ban having no relation to truth or falsity. That means that there’s no plausible state-law cognate in the fraud/consumer fraud area, since those state-law claims turn on truth or falsity. Once again the state-law parallel is elusive. The same holds true in the RICO context for predicate acts of mail fraud/wire fraud - claims also dependent upon falsity. Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, 2008 WL 5335062, at *7 (C.D. Cal. Dec. 17, 2008).
In all these situations, there's nothing more than the FDA’s decision to ban off-label promotion – and only the government can enforce that.
So on the legal front, we like the new Guidance because it provides us with a pithy statement by the FDA itself of the statutory basis for its off-label promotion ban. The agency’s statement will be very handy in exposing attempts to enforce the FDA’s ban as the private enforcement actions that they are.
We’ll turn to the next paragraph now.
Contrast the legal underpinnings of the FDA’s off-label promotion ban with the policy rationale the agency gives for the new Guidance. The difference could not be starker – while truth and safety are irrelevant to the ban itself, the new Guidance is all about safety and truth:
FDA does recognize, however, the important public health and policy justification supporting dissemination of truthful and non-misleading [information] on unapproved uses of approved drugs and approved or cleared medical devices to healthcare professionals and healthcare entities. Once a drug or medical device has been approved or cleared by FDA, generally, healthcare professionals may lawfully use or prescribe that product for uses or treatment regimens that are not included in the product’s approved labeling. . . . These off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care. Accordingly, the public health may be advanced by healthcare professionals’ receipt of [information] on unapproved new uses of approved or cleared medical products that are truthful and not misleading.
2009 WL 35467, at *13 (hypertechnical parenthetical omitted) (emphasis added).
Note that we put the rabbit in the hat.
We’ve substituted “[information]” for “medical journal articles and medical or scientific reference publications” – the language that the FDA uses in the Guidance. And we didn’t do that just to make the block quote shorter.
We did it because we don’t think there’s a legally valid distinction to be drawn between the narrow universe of truthful information that the Guidance permits manufacturers to distribute and the broader universe of other, equally truthful information – especially considering the intended audience of trained medical professionals.
For example, as long as a textbook is in fact “truthful and not misleading,” why does it matter whether it was “edited or significantly influenced by. . .individuals having a financial relationship with the manufacturer,” as the Guidance requires? Why, for that matter, must information be in the form of an article or a textbook at all? If the information is truthful – and contains necessary disclosures of potential financial conflicts and off-label status – this sophisticated audience can be relied upon to give it the weight it deserves, which in a lot of cases would undoubtedly be immediate consignment to the circular file.
We think that, once the FDA recognizes an exception for any sort of truthful information, then the public health rationale for banning truthful information evaporates. If we have to file another First Amendment brief on off-label use, this new exception to the FDA’s ban will be front and center of an argument that the ban is so inconsistent and riddled with holes that it can’t stand scrutiny under Greater New Orleans Broadcasting Ass’n v. United States, 527 U.S. 173 (1999), and Rubin v. Coors Brewing Co., 514 U.S. 476 (1995).
Properly presented to a court, this new Guidance badly undercuts whatever rationales the government could offer for the ban, since it effectively concedes that disclaimers and disclosures are sufficient guarantees that truthful information won’t nevertheless be “misleading.” That moves the legal arguments involving off-label promotion a long way in the direction of the drubbing that the FDA took in Thompson v. Western States Medical Center, 535 U.S. 357 (2002).
Now both of our blogging compatriots point out that Congressman Waxman, for one, believes that the FDA is being too lenient. We find that a little hard to believe given that the information the FDA deigns to allow manufacturers to distribute:
- Must be a textbook or genuinely peer-reviewed medical article;
- Must discuss an “adequate and well-controlled clinical investigation”;
- Must include extant contrary scientific evidence;
- Can’t be edited or influenced by the manufacturer that distributes it;
- Must disclose every conceivable basis for potential financial conflict of interest;
- Must be clearly labeled as involving an off-label use; and
- Cannot be distributed as part of any other promotional activity.
So, if Congressman Waxman wants to recriminalize the distribution of this sort of material, more power to him (Dirty Harry would put it differently). While the prospect of an FDA enforcement action is a big deal from a practical and financial standpoint, and we’d never tell a client to violate the law, from a constitutional perspective it really doesn’t matter that much what the would-be Big Brothers in Congress might do now. The more truthful speech Congress chooses to criminalize, the bigger a First Amendment target they put on the FDA’s ban on off-label promotion.
If, as appears to be the case, pornography on the Internet is constitutionally protected, what plausible argument can there be that the type of scientific speech the FDA’s new Guidance permits is not entitled to at least as much protection from government prohibition?