FDA Publishes Guidance on Off-Label Use Communications

By Elizabeth O’Connell and Lee H. Rosebush on March 9, 2017 Posted in Uncategorized

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and the FDA’s power to regulate such communications. The publications are the FDA’s response to years of conflict between drug makers, which contend they have a first amendment right to communicate off label or information … Continue Reading

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

By Lee H. Rosebush and Nita Garg on August 19, 2015 Posted in Uncategorized

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that Amarin has a constitutional right to make certain “truthful and non-misleading” statements regarding unapproved uses of its drug, Vascepa. … Continue Reading

Amarin Pharma Sues FDA Over Constitutional Right to Discuss Off-Label Uses

By Lee H. Rosebush and Nita Garg on May 14, 2015 Posted in Uncategorized

Drug makers and the Food and Drug Administration (FDA) have often disagreed over whether drug makers can discuss unapproved uses for their products with physicians. While courts have sided with drug makers in certain situations, the federal government (including the FDA, HHS-OIG, and DOJ) still holds policies and positions that disapprove of the practice. In … Continue Reading