During the second day of the Food and Drug Law Institute Conference on Advertising and Promotion (#FDLIAP), I participated on a panel to discuss the First Amendment and the Regulation of Commercial speech. The panel was made up of a general counsel for a pharma company, a law professor and a practitioner from a large law firm who used to work at FDA.
The focus of my comments was in regard to the First Amendment and the regulation of social media. As we are all aware, the First Amendment guarantees a freedom of speech to individuals which can only be abridged by government when there is a "compelling" interest.
Commercial speech is not regarded as highly as personal speech. Commercial speech must be truthful and not deceptive. But to abridge even commercial speech, there are standards – the government need not have a "compelling" interest, but must show that it has a "substantial" interest" which would include, for example, the protection of public health.
There have been two regulatory actions regarding the Internet and social media by the FDA. The first, in April 2009, involved the well-known 14 Notice of Violation letters sent covering 45 brands for paid search advertisements on the Internet. The issue was that within the context of the ads, there was mention of a drug and it's indication without immediate sight of risk information since it was one click away by link contained in the ad. The second was another NOV recently sent in July 2010 involving a Facebook "share" function.
In both of these cases, therefore, the question becomes this – was there a "substantial" interest on the part of government to abridge this commercial speech in order to protect the public health.
In other words, what is the evidence that a threat to public health existed. Yes, the regulations state that risk information must be included, but doesn't the link to risk information in paid search advertisement provide that inclusion? Or are we trying to enforce old print rules on new media that don't fit. In any case, do such ads result in members of the public deciding to take a medical product mentioned in a search engine advertisement and actually obtain a prescription from a physician? Doubtful. It is much more likely that an Internet user would click through to the ad, or perform a separate search to learn more about the product. After all, the few words contained in the short ad are hardly compelling, and even if the patient is convinced, would the doctor be convinced?
But were there public health consequences to the action that were unintended with the act of enforcement? Certainly manufacturers have felt chilled in their expression of commercial speech regarding their products. In fact, product-specific misinformation that might be present on Internet resources such as Wikis are not likely to be corrected by companies. Yet the Internet, and wikis, are a frequent resource for patients researching treatments. Oddly enough, if the FDA would use one of its own several twitter feeds to send out a safety message about a compound that included the name and the indication, a company would technically be unable to re-tweet this public safety message.
In the end, one has to ask oneself, is there a greater chance of harm in the unlikely event a member of the public feels compelled to get a prescription based on the content of a paid search ad that contains a link to risk information, or after seeing a drug mentioned in the "share" function on Facebook, or is the greater chance of harm occurring when the speech of companies about their own products is chilled to the point that educating patients about disease states or correcting misinformation in public forums doesn't take place?