Amarin Pharma Decision Reiterates Importance of Disclosures in Off-Label Promotion

The FDA wants to ignore the Second Circuit’s opinion in United States v. Caronia.

As I am frequently wont to do with my two sons, I quote the Rolling Stones in response to the FDA’s desire to disregard Caronia – “You can’t always get what you want.”

The agency does not want to allow off-label promotion of drugs – even off-label promotion that is truthful and non-misleading and includes appropriate disclosures.  As previously discussed, the agency is not opposed to off-label communication, as long as that communication more or less fits within guidance it has provided to the pharmaceutical industry.  But despite Caronia, the FDA wants to continue prohibiting truthful and non-misleading off-label promotion rather than look at less restrictive methods to address its interest in protecting the public from the potential risks of having this information available in the marketplace.

District Judge Paul A. Englemayer of the Southern District of New York took the FDA to task for its disregard of Caronia.  In his opinion in Amarin Pharma, Inc. v. FDA, Judge Englemayer stated:

“The Second Circuit’s decision in Caronia reflected a careful Central Hudson analysis.  And the Circuit, in Caronia, identified alternative, and less speech-restrictive, means for the FDA to achieve its objectives. The FDA’s quarrel is, therefore, ultimately, with Caronia.  Notably, however, despite a vigorous dissent to the effect that the panel majority had ‘call[ed] into question the very foundations of our century-old system of drug regulation,’ the Government neither sought rehearing nor petitioned for certiorari in Caronia (citation omitted).”

Conventional wisdom is that the FDA did not appeal Caronia because the agency thought it could distinguish the case by limiting it to its facts.

Judge Englemayer would have none of that in deciding that FDA could not prosecute Amarin for misbranding as a result of engaging in truthful and non-misleading promotion of its drug, Vascepa.  He concluded:

“The Court’s considered and firm view is that, under Caronia, the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment.  A fair reading of that decision refutes the FDA’s view that the Second Circuit’s ruling was limited to the facts of Caronia’s particular case.”

Instead, Judge Englemayer ruled that the Second Circuit’s Central Hudson analysis in Caronia made clear that restrictions on truthful, non-misleading speech aimed at preventing the misbranding of drugs must pass Constitutional muster, including being narrowly tailored.  He “reject[ed] the FDA’s reading of Caronia as a mere artifact of that case’s particular facts and circumstances.”

In analyzing the constitutionality of the FDA’s restriction on off-label promotion under the Central Hudson test, the Second Circuit outlined a pathway to off-label promotion that involved disclosures as a more narrowly tailored restriction on protected speech.  Judge Englemayer’s opinion in Amarin Pharma embraced this pathway.  He engaged in a thorough and thoughtful analysis of Amarin’s proposed disclosures and the FDA’s responses to those proposals to arrive at a set of disclosures intended to provide appropriate context to Amarin’s off-label messaging.

Time will tell whether the FDA also embraces this pathway.  The FDA has yet to hold the public meeting that it announced earlier this year would take place to gather information to allow the agency to further consider its position on off-label promotion.  It is unknown what impact Judge Englemayer’s decision in Amarin Pharma may have on that meeting.  It also is unknown what the FDA’s legal response will be to the decision.  Will the FDA let the decision lie and try to distinguish it on it facts, which may be easier to do than with Caronia?  Or will the agency accept the broader implications of the decision?

The broader implications of more truthful speech are better informed treatment decisions.  In weighing the balance of equities and the public interest as part of his analysis of the propriety of preliminary relief, Judge Englemayer came down firmly on the side of not chilling Amarin’s First Amendment rights and – following the precedent set in Caronia – against a regulatory scheme that seeks to criminalize speech, even truthful speech.

In this section of the Amarin Pharma opinion, Judge Englemayer dismissed the FDA’s argument that a ruling in favor of Amarin would undermine the drug approval process.  He chided the agency on this point when he stated:

“Had the FDA believed that Caronia gravely undermined the drug approval process, it should have sought review of that decision.”

As in Caronia, the FDA clearly did not get what it wanted in Amarin Pharma.  At some point, however, the agency just might find it got what it needs – a pathway that allows for truthful and non-misleading off-label promotion and provides health care professionals and the patients they treat with more information, not less.