FDA Looks To Placate Amarin, Duck Free Speech Decision
Law360, New York (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...
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