We received a couple of odd anonymous comments to our “breaking news” post about the Amarin First Amendment victory for truthful off-label promotion. Both of them raised the same suggestion: “Does the logic of this opinion permit a generic manufacturer to include truthful warnings about the risks of a drug on its labeling when such truthful warnings do not appear on the labeling of the branded drug?”
Not much later, we saw the same point raised by a plaintiff-side lawyer in this story in 360:
“I think this decision has huge implications for the preemption doctrine,” Lou Bograd of the Center for Constitutional Litigation PC said.
“If it's the case that drug companies have the First Amendment right to make truthful statements about off-label uses, and the FDA cannot prohibit them, then it follows that they would have the First Amendment right to truthfully communicate the risks of their products even if that information isn't on the label of the brand-name products,” he said.
Needless to say, we don’t think that’s true. Moreover, if plaintiffs try for what amounts to an Amarin-based Hail Mary pass, it may even create a jurisdictional advantage for our side.
There may be others, but right now we see two reasons why the FDA’s speech-based prohibition on truthful off-label promotion is not the First Amendment equivalent of the FDA’s sameness-based requirement that generic drug manufacturers to receive prior Agency approval for all substantive label changes.
First reason: The first FDA scheme (off-label promotion) is a flat ban – a prior restraint − backed by criminal penalties, fines, and the threat of False Claims Act civil actions. That’s all discussed in the Amarin decision. See Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039, at *5-6 (S.D.N.Y. Aug. 7, 2015). The second FDA scheme (generic label changes) is a reasonable time, place, and manner restriction that simply requires the submission of all would-be warning changes to the FDA so that it can see that the statute’s non-speech-related sameness requirements are met. The statutory sameness requirements have nothing to do with the substance of the warning changes, and everything to so with the basic bioequivalence requirement that is at the core of the Hatch-Waxman Act. Unless they’re the “same,” generics simply aren’t generics. Nor does the FDA ban label changes for generic products; it simply requires agency review before they happen, rather than afterwards (as is the case with its CBE process).
So we don’t think, in First Amendment terms, that the off-label promotion ban is in the slightest bit equivalent to how the Agency chooses to time review of generic label changes. The demise of the first says nothing about the validity of the second.
Second reason: Remember what procedure the manufacturer followed with respect to its proposed truthful off-label promotion in Amarin:
The FDA does, however, encourage manufacturers to request advisory comments . . . with respect to promotional materials aimed at healthcare professionals. . . . The FDA’s Office of Prescription Drug Promotion (the “OPDP”) reviews such materials to ensure, inter alia, that they are not false or misleading; it provides written comments on proposed materials, reviews complaints of alleged violations, and initiates enforcement actions as to materials it finds false or misleading.
2015 WL 4720039, at *6 (footnotes omitted). Amarin thus approached the FDA and asked it to bless its promotional materials, and the FDA refused:
The FDA also refused to approve Amarin’s request to include the ANCHOR results in the Vascepa label. It “reserve[d] comment” until the application is otherwise adequate. In the penultimate sentence of the [rejection letter], the FDA stated: “This product may be considered to be misbranded under the [FDCA] if it is marketed with this change before approval of this supplemental application.”
Id. at *12.
Thus, Amarin approached the FDA ahead of time and sought, if not approval, at least Agency acquiescence in its truthful off-label promotion. That’s all well and good, but it’s not something that can defeat preemption. Rather, it’s a variant of the less-than-formal-submission “take steps” approach that the FDA proposed, and the Supreme Court rejected, in PLIVA v. Mensing, 131 S.Ct. 2567 (2011), as a ground for defeating preemption:
[T]he agency asserts that a different avenue existed for changing generic drug labels. According to the FDA, the Manufacturers could have proposed − indeed, were required to propose − stronger warning labels to the agency if they believed such warnings were needed. If the FDA had agreed that a label change was necessary, it would have worked with the brand-name manufacturer to create a new label for both the brand-name and generic drug.
Id. at 2576 (citations omitted). Going to the FDA (as Amarin did in the First Amendment context), and seeking its agreement to a label change doesn’t make simultaneous compliance with state and federal duties “possible” under Mensing:
The federal duty to ask the FDA for help in strengthening the corresponding brand-name label, assuming such a duty exists, does not change this analysis. Although requesting FDA assistance would have satisfied the Manufacturers’ federal duty, it would not have satisfied their state tort-law duty to provide adequate labeling. State law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.
Id. at 2578. What Amarin did is precisely what the Supreme Court held in Mensing does not ameliorate the “impossibility” of simultaneous compliance with both federal and state duties.
There may be more, but those are two reasons that come to mind why generic plaintiffs should get nowhere with a last gasp “truthful speech” argument (assuming truth, which may also be disputed) against Mensing/Bartlett preemption.
But there’s somewhere else that plaintiffs might get with such an argument – into federal court.
We’ve blogged before about the availability of federal question jurisdiction in certain types of prescription medical product liability litigation under Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005). Successful invocations of Grable-based federal question jurisdiction have been few and far between. The Supreme Court’s latest iteration of the test for such jurisdiction is found in Gunn v. Minton, 133 S.Ct. 1059 (2013).
[F]ederal jurisdiction over a state law claim will lie if a federal issue is: (1) necessarily raised, (2) actually disputed, (3) substantial, and (4) capable of resolution in federal court without disrupting the federal-state balance approved by Congress.
Id. at 1065.
Most Grable-based attempts to remove cases to federal court have foundered on prong three – substantiality. With few exceptions, device-specific claims of “parallel-claim” FDCA violations, tied causally to the timing of a particular plaintiff’s medical history haven’t been able to overcome the substantiality requirement. A few other cases have, however. Take, for example NASDAQ OMX Grooup, Inc. v. UBS Securities, LLC, 770 F.3d 1010 (2d Cir. 2014), where it wasn’t just the removing defendant claiming substantiality, but also the relevant government agency. Specifically, the Securities & Exchange Commission made a statement about the federal interests involved in NASDAQ OMX that “strongly signal[ed] the substantial importance of the federal issues” at stake in the litigation. Id.at 1025.
The same thing could be said about the FDA’s position on First Amendment protection for truthful off-label promotion. In Amarin, for example, the Agency characterized the company’s position as “a frontal assault . . . on the framework for new drug approval that Congress created in 1962” with “the potential to eviscerate [the] FDA drug approval regime.” 2015 WL 4720039, at *25. In a prior Amarin post we mentioned another statement by the Agency that:
In discharging its regulatory responsibilities, however, FDA has reviewed other alternatives − including all of those identified in Caronia, 703 F.3d at 168 − but has found them all inadequate to meet public health needs, and therefore not viable less restrictive alternatives to the regulatory approach adopted by FDA.
Quoting FDA brief at 38.
We don’t think that First Amendment protection of truthful promotional speech about drugs, on- or off label, means that the sky is falling, but the FDA certainly does. Remember the Agency’s explosive rhetoric in the Solis case? We blogged about it here. The FDA claimed that recognizing free speech rights to off-label promotion would mean that “vast areas of federal and state law would be invalidated.” Since one of the prongs of the commercial speech test in Central Hudson Gas & Electric Corp. v. Public Service Commission, is a “a substantial interest to be achieved by restrictions on commercial speech,” 447 U.S. 557, 564 (1980), we’re certain that mining the government’s briefs in prior First Amendment litigation such as United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), will yield numerous governmental statements at least as full-throated as the one that established theGunn/Grable substantiality in NASDAQ OMX.
The final factor of the Gunn/Grable federal jurisdiction test, that the federal dispute be “capable of resolution in federal court without disrupting the federal-state balance approved by Congress,” would also seem easily satisfied in a generic preemption case where the plaintiffs are raising the First Amendment. Given the broad scope of generic preemption, there’s unlikely to be many other, confounding arguments. Amarin shows the ability of federal courts to address such First Amendment issues. Finally, given the FDA’s prior position that the ban is necessary to protect the “substantial’ interest in encouraging submission of new uses for drugs to the Agency, it and any generic defendant are likely to find some common ground on what exactly does, or does not, “disrupt” the “federal-state balance.”
So if generic plaintiffs want to join us in driving a First Amendment stake through the heart of the FDA’s ban on truthful off-label promotion, be our guest. We think that there’s a world of difference between that absolute prohibition and FDA regulations regarding how and when generic labels are updated, but we’ll happily pocket the other side’s signing on to the initial proposition found in Amarin - that pharmaceutical detailing is accorded free speech protection when truthful. First Amendment-related arguments of this sort by plaintiff lawyers can only help innovator drug and medical device defendants in product liability litigation involving off-label promotion allegations. Nor do we think – for the reasons stated − that such arguments will ultimately have much effect on generic preemption, except for ensuring that the venue in which they are heard is federal.