On Tuesday, March 8, 2016 The United States Food and Drug Administration (FDA) and Amarin announced that they reached a milestone settlement in connection with the First Amendment suit concerning the off-label promotion of Vascepa. As expected, with this agreement come questions from the industry as well as related concerns regarding promotional activities within the industry:
Is this a “one off” that applies only to Vascepa, or does it broadly affect the promotion of prescription drugs in general? If only Amarin, can other companies seek the legal right to also publish any off-label claims, citing this decision?
Realizing that regulations take many years to draft and finalize, how will any wider changes be communicated pending revised regulations? And how does this decision potentially affect firms against whom the federal government has previously taken actions, such as CIAs, import bans, and especially penalties imposed under the False Claims Act?
In this 60 minute webinar, QPharma’s General Counsel, Jonathan Wright, will clarify the content of this agreement; contemplate its legal and practical impact on the industry and its certain key stakeholders, particularly including those manufacturers under CIAs for similar activities; and discuss key concerns that may arise from this type of promotion moving forward.
“Given that other notable companies are under CIAs and similar mechanisms of scrutiny for their off-label assertions, has the FDA opened itself up to scrutiny with respect to its “even-handed” practices against pharmaceutical companies and stakeholders, or has the FDA opened the door for, say, heightened lobbyist efforts for said companies bent on obtaining the ‘Amarin Treatment’?”
“Might there be any regulatory or statutory amendments in store, given the Amarin settlement agreement? Will FDA be issuing new guidance, and whose input will they seek?”
These type questions and more are those which Mr. Wright will explore and discuss throughout the presentation. Attendees will have time for questions at select times during the presentation as well as at the end of the presentation.