Saul Perloff (US)

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Amarin and FDA settle off-label suit

By Robert Rouder (US), Katharyn Grant (US) and Saul Perloff (US) on March 9, 2016 Posted in FDA & Food Safety

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 … Continue reading

FDA is Keeping up with Kim Kardashian

By Saul Perloff (US) on August 12, 2015 Posted in FDA & Food Safety

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 sickness. She indicated that “it’s been studied and there was no increased risk to the baby. … Continue reading

FDA continues to take aim at misleading internet advertising

By Saul Perloff (US) and Katharyn Grant (US) on March 9, 2015 Posted in FDA & Food Safety

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 the targeted companies manufacture foods or dietary supplements. The FDA’s recent actions signal its ongoing … Continue reading

FDA proposes move to electronic labeling

By Saul Perloff (US) on December 16, 2014 Posted in Regulatory

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 – often called the Package Insert or PI – is distributed in paper form either … Continue reading

Supreme Court issues 8-0 decision backing Pom Wonderful

By Saul Perloff (US) on June 19, 2014 Posted in FDA & Food Safety

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 Food, Drug, and Cosmetic Act (FDCA) barred private parties from prosecuting Lanham Act claims based on a defendant’s deceptive … Continue reading