Amarin Wins Off-Label Case Against FDA

Amarin Corp. said it received a favorable U.S. District Court decision in the company's lawsuit against the U.S. Food and Drug Administration regarding the drug maker's ability to promote information related to off-label uses of its prescription fish-oil pill.

According to Amarin, the court ruled that the company has the right, under the First Amendment, to promote information to health-care professionals about certain uses of Vascepa that aren't covered by the drug's FDA-approved labeling—as long as the information is true and not misleading.

A FDA representative declined to comment.

Amarin had filed its suit in May in a move that was expected to have broad ramifications for the way the pharmaceutical industry markets medicines and interacts with physicians.

Shares of Amarin surged 21% to $2.49 following the ruling.

Amarin wanted to provide doctors with clinical trial data that didn't directly pertain to the approved uses of its Vascepa prescription fish-oil pill. The FDA had endorsed the drug to treat people with very high levels of triglycerides, a type of fat in the blood that can lead to heart disease.

Amarin said it can now use information from research that showed Vascepa reduced the risk of coronary heart disease. Amarin had sought to sell the drug to people with lower levels of triglycerides.

Amarin said it can now use information from clinical trials and scientific publications related to Vascepa's potential to reduce the risk of cardiovascular disease. Amarin said it plans to begin promotional activities as soon as possible.

An appeal of the ruling can be filed within 60 days, Amarin said.

The question over where drug makers should be allowed to distribute information about unapproved uses of their medicines has been widely debated after a federal appeals court overturned the criminal conviction of a sales rep for promoting so-called off-label uses of a drug three years ago. The court ruled his actions constituted protected speech because the information was truthful and not misleading.

Since then, the pharmaceutical industry has been lobbying the FDA to revise its guidelines, because the decision only applied to three states.

Write to Chelsey Dulaney at [e-mail]

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