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.
