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Amarin

Latest Headlines

Latest Headlines

Med tech execs strike back at FDA regulation for off-label device marketing

Two med tech execs are pushing back at the FDA's regulation of device marketing, claiming that the agency violated their constitutional right to free speech by restricting off-label marketing for certain products.

UPDATED: Second drugmaker sues FDA over drug marketing, cites Amarin's 'free speech' win

It looks like the federal court ruling last month that Amarin had the "free speech" right to promote its fish oil product Vascepa for off-label use will become nettlesome to the FDA. A second drugmaker, Pacira, has now filed suit looking for a court to grant it similar permission on the way it markets its pain drug Exparel.

Precedent from Amarin's off-label promotion victory covers devices too, especially those marketing a surrogate endpoint

A recent court ruling inhibiting the FDA from punishing Amarin for off-label promotion deemed truthful and non-misleading shook up the pharma world. The ruling was made for reasons "totally extrinsic to the definition of a drug," and its principles "definitely apply to medical devices," said attorney Coleen Klasmeier in an interview. She heads the food, drug and medical device regulatory practice team at Sidley Austin LLP.

Amarin case could unleash a flood of off-label promos

Off-label marketing has another legal stamp of approval, thanks to Amarin and its feisty pushback against the FDA. The Ireland-based pharma has been fighting for more than a year to promote its fish oil-derived pill for broader use, and it can now do so, even without FDA approval. And thanks to Amarin's legal maneuvering--and savvy choice of jurisdiction--any other drugmaker with truth on its side might soon do the same.

Amarin wins injunction against FDA in free speech case

On Friday, Amarin won what was being called a First Amendment free speech victory for drugmakers. It got a federal court to say the FDA cannot bar Amarin from discussing off-label use of its fish-oil drug Vascepa for a wider group of patients than it is approved for.

You're free to speak, FDA tells Amarin in bid to deflate free-speech suit

Pharma marketers are closely watching Amarin's lawsuit demanding the right to talk up the off-label uses for its cardiovascular drug Vascepa. After all, if the legal attack against FDA regulations succeeds, that gives credence to drugmakers' free speech argument--and could open up new worlds of drug promotion.

Why sue, FDA asks Amarin: You can spread the word on Vascepa already

Pharma marketers are closely watching Amarin's lawsuit demanding the right to talk up the off-label uses for its cardiovascular drug Vascepa. After all, if the legal attack against FDA regulations succeeds, that gives credence to drugmakers' free speech argument--and could open up new worlds of drug promotion.

Court grants Amarin long-awaited Vascepa exclusivity

Amarin has finally grabbed the 5-year marketing exclusivity for fish oil pill Vascepa that it's long been seeking.

FDA lawsuit in hand, Amarin plots a new Vascepa marketing strategy

Amarin styled its lawsuit against the FDA looking to lift the restrictions in place on its marketing case for the prescription-strength fish oil Vascepa as a First Amendment issue regarding free speech.

Secret doctor letter shows Amarin's true 'free speech' leanings

In case you're in doubt about why pharma is suddenly all about the First Amendment, here's some illuminating evidence. In a letter obtained by  CardioBrief 's Larry Husten, Amarin makes very clear that it sued FDA last week for marketing reasons, not out of love for the Bill of Rights.
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