The Gray Area in FDA Regulation of Celebrity Endorsement of Drugs

DTC ads using social media are essential for marketing of a new drug and celebrity endorsements are a necessary component of it, particularly if the target population is broad. A company can reach a much wider audience using a recognized name. However, these endorsements frequently cross the fine line between FDA allowed communication and off-label promotion. In the age of FDA permitted off-label promotion, companies carefully wordsmith their celebrity endorsements to stay in the gray area. FDA allows several kinds of celebrity endorsements. The safest is as a presenter in an ad where the celebrity can talk the script. One cannot lie on the ad, so if the celebrity endorses a product, usually it can only be because he/she has used the product or knows about a close friend or family using it. Such ads are regulated like any other in that the company has to get it approved by the FDA before public release. The other kinds of celebrity endorsements are riskier. Celebrity tweets or posts on Instagram, are could easily get in trouble as they lack full disclosure of safety information. More riskier are appearances on talk shows, interviews and other places which could be unscripted. Such talks about a drug could easily create issues of non-compliance. To avoid that situation while still allowing a celebrity to talk freely about their interests, companies create general “education” campaigns. These campaigns do not directly talk about a given product but rather talk about a disease. In such disease awareness campaigns, using carefully worded statements, the target patients are steered towards the given product without ever using the name of the product. Such campaigns do not require FDA approval. These campaigns tread the fine line between education and promotion. Education can be promotional in nature so FDA arguably pays very close attention to see if laws are ever broken. Advertisers have become much smarter at these and can play the cat and mouse game effectively staying ahead of FDA in such campaigns. With the recent legal history of courts increasingly siding with the companies for making truthful non-misleading off-label statements, we are in interesting times of creative advertisement