United States: December Is FDA's Month For Giving And Delaying

Last Updated: December 21 2015
Article by Michael A. Walsh

FDA capitulates, dropping a meritless enforcement action against Pacira and putting off Amarin until February 17, 2016.

Three years have passed since the Second Circuit paved new ground with the landmark decision in US v. Caronia. At the time, some commentators opined that the FDA enforcement world as the government knew it had ended and it was time to rethink how the FDA and industry could work in tandem to navigate the treacherous waters of regulating the speech of FDA regulated industry. Chief Justice Rehnquist foresaw this day in his dissenting opinion in Central Hudson, but all now agree it is time for industry and FDA to jointly fashion a regulatory regimen that anticipates due process, the First Amendment and limits arbitrary agency action. As Amarin and Pacira demonstrate, the FDA has finally come to peace with defeat and has placed among its "Front Burner Priorities" the task to "[r]e-evaluate our regulation of drug advertising and promotion in light of current jurisprudence around the 1st Amendment." There are plenty of good reasons for the FDA and industry to work together to solve the issue of who, what, where, when, why and how something less than two random control clinical trials can be relied on when disseminating information in the marketing of FDA regulated products.

In Amarin v. FDA, 1:15-CV-03588-PAE, Doc. 73 (SDNY Aug. 7, 2015). The Court built on Caronia and handed the FDA a complete defeat granting a preliminary injunction concerning enforcement for disseminating information not in the Food and Drug Administration (FDA) approved label (i.e. off-label). The court concluded that more, not less, truthful information was needed. 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 ruled that "the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment." The court also 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."

After granting preliminary relief, the court ordered the parties to meet and file a report "as to the future course and next steps in the case." The deadline was originally August 28, 2015, a date that has been repeatedly moved to allow the parties to "continue to engage in settlement discussions." On December 16, 2015, the deadline was moved yet again, this time until February 17, 2016.

On Sept. 9, 2015, shortly after the FDA's shellacking in Amarin, the Southern District had yet another significant case challenging FDA's enforcement on First Amendment grounds. In Pacira v. FDA 15-cv-7055-RA, the plaintiff alleged that the FDA had declared truthful information to be false and punished the manufacturer for disseminating "false information." For a discussion of the dispute in Pacira see our prior post here. Procedurally similar to Amarin, Pacira was in the driver's seat because the FDA had little leverage to threaten Pacira into defeat.

While Pacira added nothing new to the festering constitutional hubbub in the Second Circuit created by Sorrell v IMS and then US v Caronia, Pacira boasted something more, unique and compelling facts. The First Amendment speech at issue for Pacira concerned "on-label information about use of a product for its FDA-approved indication" appeared to all on-lookers to be a sure win for Pacira. Apparently, the FDA agreed. On October 13, 2015 the FDA took an unusual step and rescinded the Warning Letter sent to Pacira and, at the insistence of Pacira, in the parties' Stipulation and Order of Dismissal filed on December 14, 2015, the FDA posted its letter to Pacira explaining the reasoning (here) for withdrawing the Warning Letter and putting a happy face on the terms of the Stipulation and Order resolving the litigation on December 15, 2015.

In the Settlement Agreement the parties address an apparent lack of decorum and define the "Regulatory Environment" wherein Pacira and FDA "Agree that, in future interactions, they will deal with each other in an open, forthright, and fair manner." Presumably, openness, forthrightness and fair dealing were in short supply in the parties dealings in this case and, if the result is any indication, Pacira seems to have gotten the best of FDA.

The Settlement Agreement is a complete capitulation and surrender by the FDA and bears none of the usual distain the FDA has shown for Due Process and First Amendment challenges. In the Settlement, FDA acknowledges it withdrew its Warning Letter, issued an agreed letter explaining why it withdrew its Warning Letter, agreed to issue a letter approving Pacira's Labeling Supplement, and approved agreed prescribing information, all of which gave Pacira everything it had on its wish list for Christmas.

It is too bad that the FDA relented so completely because Pacira v. FDA might have been a vehicle for the further development of important precedent building on US v. Caronia. Unlike its predecessor First Amendment cases, Pacira did not concede that the speech at issue was commercial speech. This is no minor technicality, because where the manufacturer does not concede that the speech at issue is commercial speech, the burden on the government to justify its restriction on speech is much greater.

Conclusion: The Speech Dilemma – What Is That Light at the End of the Tunnel?

The FDA's regulatory enforcement ship continues to sink as a result of the agency's ongoing refusal to recognize the significance of Due Process and the First Amendment in the context of FDA oversight of speech. Earlier in 2015 FDA suggested but never followed through on its utterances that it would hold public hearings and get the reasoned voice of industry and the public to fashion new guidance on what has become a public health imperative to provide more, not less, truthful scientific and medical information to the medical community and to the public concerning approved products. It is now imperative that FDA follow through with its commitment to take the First Amendment seriously.

Before applauding the demise of FDA's stranglehold on the dissemination of truthful scientific information too loudly, manufacturers would be well advised to recognize the freight train of tort claims approaching and heed the Amarin court's suggestion to "consult with the FDA before promoting off-label use." An FDA stamp of approval on a company's marketing efforts may be a lifeline to preserve a preemption challenge. In what may turn out to be a frequently quoted statement, the Amarin court highlighted the duty owed by manufacturers stating:

"Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use... remain truthful and non-misleading."

At the same time, industry might recognize the double edge the First Amendment sword presents and take reasonable steps to recommend how the FDA might balance commerce with constitutional considerations. With history as a guide, the work is far from done because tort claimants may pose a more formidable threat to manufacturers than the FDA. Only time will tell whether industry has won the battle only to lose the war.

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
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