A few weeks back I blogged here about pharmaceutical manufacturer Amarin’s lawsuit aiming to allow it to market a fish-oil based drug for a use not approved by the FDA. The FDA denied approval because it concluded the drug had no demonstrated therapeutic benefits for that use, but Amarin claims a First Amendment right to market it for the use anyway.
Today Amarin, and by extension big Pharma, won an important early battle in that case when the U.S. District Court for the Southern District of New York, in a 70+-page opinion by Judge Paul Engelmayer, ruled that Amarin was entitled to a preliminary injunction allowing it to promote the drug for the unapproved use.
I won’t attempt to explain everything in the opinion in a short blog post, but the nub of it is this: Judge Engelmayer held that Amarin was likely to prevail in its argument that when a drug manufacturer has obtained approval to market a drug for one use, the First Amendment entitles it to market the drug for unapproved uses as well unless the FDA can prove that its marketing is false or misleading (or, perhaps, would promote an unsafe use of the drug). The ruling thus effectively reverses the Food, Drug & Cosmetic Act principle that the burden is on a manufacturer to prove a drug safe and effective for a particular use before it may market the drug for that use.