Bloomberg BNA Publishes Article Analyzing 2nd Circuit Ruling on Off-Label Drug Promotion
A recent ruling by the U.S. Court of Appeals for the 2nd Circuit regarding the off-label promotion of pharmaceutical drugs was the subject of an article by James Tysse and Patricia Millett, counsel and co-head, respectively, of Akin Gump’s appellate practice, and Mark Mansour, partner in Akin Gump’s food and drug law practice.
“Free Speech and the Future of Off-Label Pharmaceutical Marketing Regulation After United States v. Caronia” addresses how the ruling could affect the Food and Drug Administration’s stance on off-label marketing and whether it would prevent the Department of Justice from bringing future cases against individuals. The article also discusses whether the First Amendment offers enough protections for off-label speech.
Please click here to read the article.