Food and Drug Law Institute Publishes Eli Tomar Article on Possible Regulation of Compounded Drugs Promotion
Food and Drug Law Institute has published the article “Compounding the Off-Label Promotion Debate: How FDA Could Regulate the Promotion of Unapproved Drugs,” written by Akin Gump associate Eli Tomar, in Update magazine.
The article examines how the “evolving regulatory landscape” applies to the promotion of compounded drugs that have not been deemed safe and effective by the Food and Drug Administration (FDA) for the use promoted. While no law “explicitly prohibits drugmakers from promoting the use of their drugs for indications for which FDA has not approved their use (i.e., off-label),” Tomar writes that the agency still takes “a firm stance” against such promotion.
Tomar discusses why the promotion of compounded drugs cannot be regulated the same way as approved drugs and suggests ways for how the FDA might regulate them. He concludes by noting that, depending on what the FDA does, courts may eventually “be called in to decide the scope of lawful promotion of compounded drugs.”
To read the full article, available with the permission of Food and Drug Law Institute, please click here.