FLH Partner Brian J. Malkin’s Chapter, “Free Speech and Off-Label Drug Promotion: Should Recent Cases Change Your Business Practices?” is now available as part of an Aspatore Special Report, Navigating Recent Off-Label Promotion Developments: Understanding Government Regulations and the Potential Impact of Noteworthy Cases published on September 1, 2013. FLH and FDA Lawyers Blog bring to you as a special benefit a link to Mr. Malkin’s Chapter for your review and use available here.
Mr. Malkin’s Chapter provides an overview of the off-label promotion issue as well as addresses some of the most recent cases that have called into question FDA’s statutory scope of authority over such discussions. Broadly speaking, FDA permits unaffiliated doctors to prescribe and speak about offlabel uses of products approved by FDA for marketing but has limited the ability of a product’s sponsor or individuals acting on the sponsor’s behalf to do so. In some instances, violations have resulted in convictions for criminal felonies involving prison time and substantial fines, even in to the billions of dollars. A recent Second Circuit Case, United States v. Caronia, however, held that truthful, nonmisleading off-label promotion is constitutionally protectable commercial speech. FDA’s decision to not appeal the decision and official position that the ruling is very narrow and business is as usual has further complicated the issue. Mr. Malkin’s chapter takes a look at how FDA has proceeded since Caronia and provides “takeaways” for counsel when considering their products and marketing materials.