We have been following the developments in the Amarin off-label communication case for awhile and you can find our posts that provide background here, here, and here.
In brief, Amarin has an FDA-approved indication to market its fish oil supplement as a treatment for very high triglycerides. It conducted a study that showed it lowered the triglycerides in moderately high patients but the FDA declined to approve the label extension because Amarin failed to prove a link to prevention of coronary artery disease. Amarin then informed the FDA that it intended to communicate the triglyceride lowering data to the market and the FDA informed them that it would consider any such communication off-label promotion. Amarin then sued the FDA for unfair restraint. Amarin was granted an injunction against the FDA, which appealed the decision.
In the latest development, the FDA has settled with Amarin, closing down the appeal before a ruling could be made to set clear precedence. In the settlement, which can read about here, the FDA agreed that Amarin could inform doctors of the studies supporting the fact that its product lowered triglycerides in a range of patients as long as the data presented was truthful. It also set up an “optional” provision in which Amarin can meet bi-annually with the FDA to review the material that they wish to present to ensure that the FDA will find that information truthful and any disagreements from these discussions would be sent to a court to make the final decision.
The FDA’s perceived fear of a precedence setting ruling is not going to go unnoticed. Already another pharma company, Pacira, is suing the FDA under similar circumstances, which you can read about here.
If this case is also settled, expect to see the floodgates open.
It is more than past due time for the FDA to provide clear guidance to industry on the use of truthful, non-misleading communication of scientifically valid data that is not supported by the label. When that guidance is finally offered, it will be a game changer for MA. We believe that most organizations will realize that the safest way to communicate such scientific data will be through the use of peer-to-peer communication driven by medical science liaison-type roles and this will lead to a major expansion of many MSL groups.
We will continue to follow this story. We would love to know what you think. Leave a comment.