As we reported last August, U.S. District Judge Paul Engelmayer ruled that Amarin Pharma has a First Amendment right to truthfully promote its prescription drug Vascepa for off-label uses. August 10, 2015, article. Shortly afterward, Amarin and the government entered settlement talks. August 31, 2015 update. We are now able to report that on March 8, 2016, the parties entered into a proposed Settlement Agreement resolving all causes of action in Amarin’s suit against the FDA.
Saul Perloff (US)
FDA is Keeping up with Kim Kardashian
Kim Kardashian’s recent Instagram post yielded 466,000 “likes” and one FDA Warning Letter. In her social media post, also posted on Facebook, Kardashian discussed the drug DICLEGIS and the positive effect she claims it has had on her morning…
FDA continues to take aim at misleading internet advertising
On February 26, 2015, the U.S. Food and Drug Administration (FDA) issued warning letters to nine manufacturers of products sold over the Internet, informing each that they improperly advertise their products with disease-related claims.
Focus on dietary supplements
Five of…
FDA proposes move to electronic labeling
On December 18, the FDA announced a long-anticipated proposed amendment to the prescription drug and biological product labeling regulations requiring electronic distribution of prescribing information intended for healthcare professionals. 79 Fed. Reg. 75506 (Dec. 18, 2014). Currently, this prescribing information…
Supreme Court issues 8-0 decision backing Pom Wonderful
On June 12, 2014, the U.S. Supreme Court issued its much anticipated opinion in Pom Wonderful LLC v. The Coca-Cola Company. Ruling in favor of Pom Wonderful, the unanimous Court[1] reversed the Ninth Circuit’s decision that the Federal…