FDA Looks To Placate Amarin, Duck Free Speech Decision

By Jeff Overley (June 8, 2015, 9:11 PM EDT) -- The U.S. Food and Drug Administration in a letter released Monday told Amarin Pharma Inc. it can make numerous off-label statements about fish oil medicine Vascepa, a move likely designed to short-circuit the company's potentially precedent-setting challenge to restrictions on free speech, experts say.

The letter was described by the FDA as an attempt to narrow the scope of a closely watched constitutional challenge that Amarin launched last month, with regulators saying they don't object to most of what the Irish drugmaker wants to tell doctors about research covering unapproved uses of Vascepa.

Specifically, the FDA said Amarin can talk about...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


Attached Documents

Related Sections

Case Information

Case Title

Subscribers Only

Case Number

Subscribers Only


Subscribers Only

Nature of Suit

Subscribers Only


Subscribers Only

Date Filed

Subscribers Only

Law Firms


Government Agencies

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!