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 Chelsey.Dulaney@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires