When it comes to pharmaceutical companies promoting their products, off-label discussions may now be on the table. In a court case that may have a huge impact on how pharmaceutical company representatives interact with physicians, patients, and other stakeholders, a Manhattan district court ruled last Friday that the Food and Drug Administration (FDA) cannot prevent a company from conducting an off-label promotion if the information in the promotion is truthful and scientifically accurate.

The ruling stems from Irish drugmaker Amarin PLC’s argument that the FDA cannot restrict Amarin’s off-label promotion of its fish oil pill, Vascepa® (icosapent ethyl), since any such restriction would violate its First Amendment right of free speech. Vascepa® is currently indicated as an adjunct to diet to reduce triglyceride levels in adults with severe (≥500 mg/dL) hypertriglyceridemia. According to the FDA, however, Amarin had also been promoting the off-label benefits of Vascepa® in patients with “persistently high” (20 –500 mg/dL) triglycerides, based on preliminary results of the phase 3 ANCHOR trial.1,2

Siding with Amarin and citing protection under the First Amendment, US District Court Judge Paul Engelmayer ruled in a 71-page opinion that the FDA cannot stop off-label promotion of Vascepa® as long as Amarin does so truthfully.

What does this mean for pharmaceutical companies? In the short term, nothing yet – the FDA has 60 days to appeal the ruling and it may very well do so. Also, any immediate impact would most likely be restricted to the Northeastern US, as the decision only applies to the second US Circuit Court of Appeals, which includes New York, Connecticut, and Vermont.

The impact of this ruling, however, should not be underestimated, as this decision sets a clear precedent allowing pharmaceutical companies to engage in off-label promotions supported by First Amendment rights. It is also possible that the FDA may cut its losses and settle with Amarin since the ruling is restricted to the local court circuit, while a loss on appeal may expand both the regional and regulatory impact of the current ruling. In the long term, if similar court cases and rulings occur in the future, this pattern could ultimately weaken the FDA’s authority and regulatory approach towards off-label promotion by the pharmaceutical industry.

Certainly, this ruling (and similar decisions in the future) does not mean that sales representatives, marketing teams, medical science liaisons and medical affairs teams will now carelessly share every unconfirmed claim for a product based solely on anecdotal evidence and minimal data. The likely consequence is that these individuals and teams within pharmaceutical companies can begin to expand their strategies and conversation approaches for key stakeholders when mapping the development and promotion of products both recently launched and mature. This could be a brave new world in drug promotion, and it will be interesting to see how this new territory is mapped going forward.

By: Nicholas DeLillo, PhD

References:

  1. FDA Law Blog. A Victory for Amarin Further Erodes FDA Regulation of Off-label Promotion. 8/10/2015. Available at: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/08/a-victory-for-amarin-further-erodes-fda-regulation-of-off-label-promotion.html Accessed August 12, 2015.
  2. AMARIN PHARMA INC vs US FDA. http://www.aboutlawsuits.com/wp-content/uploads/2015-5-8-Amarin-offlabel-lawsuit.pdf Accessed August 12, 2015.