The United States Food and Drug Administration (FDA) and Amarin announced that they have reached a proposed settlement in connection with the First Amendment suit over the off-label promotion of Vascepa.
John Fleder, an attorney with Hyman, Phelps, & McNamara believes that in deciding to settle this case, the FDA “undoubtedly weighed the risk of moving forward with further litigation and acknowledged that if it appealed this decision, the FDA would have to go to the same court that ruled against it in Caronia”
Fleder also stated, “People have to remember that [decisions from] Caronia, Vascular and Amarin all said there is no protection to companies for statements and claims that are either untruthful or misleading, and while it may be easy to know in a particular situation whether a claim is untruthful, it is usually much more complicated issue whether a claim is misleading or not.”
Settlement Details
This settlement has been in the works for over half a year and proposes that the parties be bound by the Court’s earlier decision from August 7, 2015, that Amarin may engage in “truthful and non-misleading speech” promoting the off-label use of Vascepa.
The agreement also provided that the FDA will provide Amarin with an optional preclearance provision through 2020 for new off-label claims, and that both sides have agreed to dispute resolution provision designed to avoid future litigation. The preclearance provision allows Amarin to submit two proposed communications per calendar year about the off-label use of Vascepa prior to publication of the communications, to determine whether or not the FDA has any concerns about the communications.
The FDA will have 60 days to contact Amarin with any objections or concerns regarding the promotional materials, though both sides may agree to extend that time period. Amarin must then provide a specific response to any concerns or objections the FDA may have, within 45 calendar days. Within 30 days of receiving their response, the FDA will notify Amarin in detail of any remaining concern. At that point, if concerns remain, the proposed settlement allows for either party to file a motion with the Court requesting judicial resolution.
The proposed settlement also includes a clause stating that, after identifying a disputed, nothing in the proposal shall be construed to prevent the FDA from communicating with physicians through any channels the FDA deems appropriate.
Analysis
This proposed settlement is the first time the FDA has conceded that pharmaceutical companies may engage in truthful and non-misleading speech promoting the off label use of the prescription drugs. While the settlement is promising, and certainly represents a significant final chapter in case that has dramatically impacted the FDA’s enforcement landscape, it also reminds companies the possibility that the FDA and the Department of Justice (DOJ) will begin to pursue off-label cases based on false or misleading speech or conduct. This possibility gives additional significance to the governments’ recent unsuccessful off-label prosecution of Vascular Inc., and its CEO, Howard Root.
The Amarin court rejected the FDA’s position that Caronia was only applicable to the facts of that specific case. Instead the court reiterated, “where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drugs, such speech, under Caronia, cannot be the act upon which an action for misbranding is based.”
However, the language of the settlement order is still specific and detailed enough that it leaves some leeway for the FDA to argue that Caronia and Amarin do not apply to future cases that either: involve false or misleading speech, involve conduct rather than speech, or, arise outside of the Second Circuit.
A copy of the proposed settlement can be found here.