United States: The Titanic Is Sinking: Caronia, Amarin And Now Pacira V FDA

Last Updated: September 11 2015
Article by Michael A. Walsh and Katherine McGahey

In 2011, the US Supreme Court decided Sorrell v US, holding that "[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment." This one phrase stated matter-of-factly what was unthinkable a generation earlier. Sorrell was a watershed event for how the Supreme Court views the First Amendment in the context of FDA-regulated industry.

In 2012 the Second Circuit decided US v Caronia. In reversing Caronia's conviction, the Second Circuit ruled that the FDA's enforcement of the Food Drug and Cosmetic Act (FDCA) violated Caronia's First Amendment rights, stating: "We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug." (See our discussion of Caronia here). Some commentators were outraged at the implications of Caronia and foretold undoing the work attributed to Frances Oldham Kelsey and a return to the horrors of products marketed without adequate warnings. Though the world today is very different than the world of Kelsey, the FDA Titanic nonetheless holds on to old arguments, while failing to meet new challenges.

As demonstrated in Sorrell and Caronia, it takes unusual facts for a case involving the FDCA and the First Amendment to reach a federal courthouse. Amarin sued the FDA in May of 2015, seeking to expand its approved drug claims to include claims being asserted by dietary supplement manufacturers for the same product. The court in Amarin flatly rejected the position the FDA has been touting for decades— that it was not prosecuting speech but conduct that is evidence of intent. The court went on to hold that "the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment." (Slip Opinion at 48). The court further rejected the government's attempt to rewrite the holding in Caronia: "Where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based." (Id. at 49)

Pacira v. FDA: Declaring The Truth False And Punishing It.

Pacira v US, 15-cv-7055-RA, (SDNY filed on Sept. 9, 2015) adds no new constitutional analysis, but what it does bring is unique facts boasting: "Pacira's case is even stronger, for while the speech at issue in Amarin and Caronia concerned "off-label" drug uses, the speech Pacira desires to engage in concerns on-label information about use of EXPAREL for its FDA-approved indication." (Brief at 1). Pacira's drug EXPAREL was indicated for general surgical use because "[a]s recognized by FDA's historical practice and regulatory guidance ... the safety and effectiveness of EXPAREL in these two well-established pain models provide a clear scientific and medical rationale for concluding that the drug's clinical benefits are generalizable to other surgical sites." (Brief at 2). The FDA-approved label did not limit the types of surgeries to those in the underlying studies. But, through its criminal enforcement power, three years after approval, FDA sought to rewrite the label to limit the indications to the two surgeries studied.

On September 22, 2014, the Company received a Warning Letter from FDA's Office of Prescription Drug Promotion objecting to the company's promotional materials and asserting a violation of the criminal provisions of the FDCA. In the FDA's defense, the Warning Letter (here) states that the clinical trial section of the label states "EXPAREL has not been demonstrated to be safe and effective in other procedures."

In response, the company tried to meet with the FDA to work out how to comply with the FDA's demands due to the fact that the indications section of the labeling did not limit the product to the surgeries studied. More importantly, the product was effective and the incidence of adverse events was low (one third of one tenth percent), but the FDA stonewalled. Given the threat of criminal sanctions, the company relented and did what the FDA demanded and refrained from disseminating truthful FDA-approved information to physicians. The FDA subsequently issued a "Close Out Letter" and Pacira continues to refrain from engaging in conduct that the FDA is barred by the First Amendment from prohibiting.

Not Commercial Speech

Pacira correctly observes that the FDA's interpretation of the regulations broadly defines the term "labeling" to include any utterance (and non-utterance) that supports the FDA's conclusion and the "FDA's interpretation of 'false or misleading' does not hinge on whether information is true." (Brief at 10). One difference in Pacira, unlike Amarin, the manufacturer is not conceding that the speech at issue is commercial speech. This is no minor technicality because where the manufacturer does not concede that the speech at issue is commercial speech and suggests that heightened scrutiny applies. The burden on the government to justify its restriction on speech is much greater when the manufacturer does not concede that intermediate scrutiny for commercial speech applies.

The FDA and Science Fiction

Pacira complains that FDA tramples the First Amendment, imposing two impermissible distinct speaker- and content-based restrictions on Pacira's ability to speak about EXPAREL. The issue for the court is whether the FDA's threatened enforcement of Pacira for discussing the use of EXPAREL in general surgeries and prohibiting statements about the drug's effectiveness runs afoul of the constraints of the First Amendment. Moreover, the FDA's position in its Warning Letter suggests that the FDA may be changing the rules to suit its purpose raising significant due process concerns. For the FDA to prevail, the court may need to agree with the FDA that "as a categorical matter . . . all claims regarding efficacy or comparative claims are false or misleading unless supported by two clinical trials, as FDA purports to do." (Brief at 9).

Before the regulatory ship sinks entirely, FDA might consider following through with what it said it would do: hold public hearings and get the reasoned voice of industry, the public, and even the public interest groups to provide guidance on what has become a public health imperative to provide more, not less, truthful scientific and medical information to the medical community and the public concerning approved products.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Michael A. Walsh
Katherine McGahey
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