Source: https://www.druganddevicelawblog.com/2015/10/the-fda-tiptoes-and-congress-splashes.html
Timestamp: 2019-04-19 10:26:45+00:00

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Here are a couple of non-litigation related matters that we thought our readers need to know about.
[I]f a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.
This language has the potential, if the FDA wanted to, to allow the prosecution of a drug or device manufacturer for an “adulterated”/”misbranded” product (for not having “adequate labeling”), merely because that manufacturer KNEW ABOUT off-label use of its products – forget promotion (truthful or otherwise). Fortunately, the FDA generally has not read this language literally. Instead it requires prior agency approval of warnings about risks peculiar to off-label uses (we discussed that here).
We described this possible regulatory “Catch 22” in detail in our prior post, which involved a relatively obscure in vitro diagnostic guidance. We pointed out that, if the FDA enforced either regulation in accordance with their literal terms, that would upset the well-established practice of off-label use by physicians, by potentially forcing manufacturers to police and deter the medical community’s off-label use. Indeed, after the enactment of 21 U.S.C. §396 (“[n]othing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease”), the FDA probably lacks the authority to interpret §804.1 in this manner.
Still, as our prior post illustrates, the FDA occasionally flirts with the literal implications of this “knows, or has knowledge” language in its intended use regulations. Indeed, a Kessler-era FDA over-reach (one of many) in this direction having to do with medical devices is why Congress added §396 to the FDCA in the first place.
In addition, FDA is proposing to amend its existing intended use regulations for drugs and devices by inserting in §§201.128 and 801.4 a reference to the proposed rule to clarify the interplay between these regulations and this proposed rule, and to conform §§201.128 and 801.4 to reflect how the Agency currently applies them to drugs and devices.
FDA is also proposing changes to §§201.128 and 801.4. First, the proposed rule would insert a reference to §1100.5 to clarify the interplay between these regulations and the proposed rule. Second, as discussed previously, the Agency does not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use (see Ref. 5). Accordingly, FDA is taking this opportunity to amend §§201.128 and 801.4 to better reflect FDA’s interpretation and application of these regulations. These changes would not reflect a change in FDA’s approach regarding evidence of intended use for drugs and devices. These clarifying changes to the intended use regulations would apply to drugs and devices generally, and not just to products made or derived from tobacco and intended for human consumption.
80 Fed. Reg. 57756, 57756 (summary of major positions), 57761 (Proposed Changes to Existing “Intended Use” Regulations) (FDA Sept. 25, 2015) (emphasis added).
This isn’t much movement, but it’s a little. This is the first time that these regulations have been substantively amended since 1952 – 63 years ago. Moreover, we believe that this change was the result of recent First Amendment litigation. Just look at the FDA’s “reference 5” − Defendant’s [FDA’s] Memorandum of Points & Authorities In Support of Motion to Dismiss or Summary Judgment, Allergan Inc., v. United States of America, 1:09-cv-01879-JDB (D.D.C. Jan. 11, 2010). The Allergan litigation was pre-Sorrell, pre-Caronia, pre-Amarin First Amendment litigation over truthful off-label promotion. We covered the FDA filing of the motion it now references here, including the knowledge/intent concession that Allergan extracted from the Agency. The FDA didn’t even win its motion; instead, it settled that litigation, and one of the terms required that Amgen’s First Amendment challenge be dropped.
The FDA initially made its concession in early 2010. It settled Allergan in September 2010. Then, as we’ve already chronicled, it promptly tried ignoring that concession in June 2011, in the in vitro diagnostic guidance. Now it’s gone all the way in the other direction. One can’t help but think that Sorrell (later that same June 2011), Caronia (December 2012), and finally Amarin (August 2015) had something to do with both the substance and the timing of the FDA’s new proposal to modify its “intended use” regulations.
The words intended uses or words of similar import in [differing cross references] of this chapter refer to the objective intent of the persons legally responsible for the labeling of [drugs/devices]. The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the [drug/device], such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.
80 Fed. Reg. at 57764-65 (combining identical language).
The words intended uses or words of similar import in [differing cross references] of this chapter refer to the objective intent of the persons legally responsible for the labeling of [drugs/devices]. The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. [Objective intent cannot be shown by truthful promotion alone. Truthful and nonmisleading promotional speech consisting of, for example, summaries and reprints of published studies, claims approved for use on similar [drugs/devices], and/or proactive truthful statements and dialogues with doctors about uses for which the article is neither labeled nor advertised is not evidence of objective intent to change an article’s intended use.] The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the [drug/device], such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.
With minor modifications, the highlighted addition was simply taken verbatim from portions of the Amarin decision that we quoted in our initial post on that win. We’re not wedded to it, and organizations like the industry amici that filed in Solis or the Washington Legal Foundation – who have doubtless thought about this for years – may well have better language to propose. With the FDA’s off-label promotion ban on the ropes, this may be a good time to force the matter through the administrative process. Indeed, since the FDA initiated the process, it can hardly assert mootness or prematurity.
Second, Congress. We thank the Civil Procedure & Federal Courts Blog for alerting us to this pending legislation, a bill (H.R. 3624), known as the “Fraudulent Joinder Prevention Act of 2015.” For those who may not know off-hand, “fraudulent joinder” is not really fraudulent, but is the descriptive term courts have used to describe the deliberate inclusion of a bogus non-diverse (resident of the same state as plaintiff) defendant for the purpose of defeating federal diversity jurisdiction, and thus keeping otherwise removable actions in state court – something defendants usually don’t want.
strongly reminiscent of our other posts advocating that courts should do precisely this.
Unfortunately, most courts don’t currently follow TwIqbal in fraudulent joinder proceedings. That reluctance is directly contrary to proper application of Erie v. Tompkins, which requires federal courts to act conservatively when applying state law, and especially to avoid predicting novel state-law theories of liability. The current fraudulent joinder standard also regularly leads to absurd situations where: (1) totally settled state law is ignored, (2) vague pleading is encouraged, or (3) plaintiffs are rewarded for inventing a theory so far out of left field – such as publisher or designer liability – that the jurisdiction in question hasn’t said anything at all about it. We suspect that the vast majority of our readers, in-house and outside (out-house?) counsel alike, have been victimized by decisions similarly giving effect to ridiculous, implausible causes of action that the current, anything-goes standard allows to defeat fraudulent joinder. That’s why this bill is a good idea.
On September 29, H.R. 3624, was the subject of a hearing before the House Judiciary Committee. That means that the committee, at least, is taking this bill seriously. We hope that our readers make their support for H.R. 3624 known, both to the committee and to their own members of Congress.

References: §396
 §804
 §396
 §1100
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