In The News

The New York Times Quotes Life Sciences Senior Counsel on FDA Ruling Affording Amarin Latitude in Off-Label Promotion

Practices: Life Sciences

An article appearing in The New York Times quotes life science senior counsel Alan Bennett (Washington, D.C.) concerning an FDA settlement with Amarin that will allow the drug company to use truthful information to promote its cardiovascular product Vascepa for unapproved uses. 

In the article, published March 8, Mr. Bennett suggests that the FDA may become more flexible in determining the propriety of off-label promotion in order to reduce the amount of lawsuits centering on this issue, and goes on to say that the FDA is better positioned to review promotional material than the courts, but it must review is policies and practices to align them with the First Amendment.

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