FDA and social media: The regulated community's current obsession overlooks off-label promotions by the advocacy community

This morning I received a tweet exhorting me to learn about Low Dose Naltrexone (LDN) for autoimmune diseases.  (Naltrexone, by the way, is approved by the FDA only to treat alcoholism.)  Within a few clicks, I found claims that LDN would be a good drug to take for dozens of conditions: everything from neuroblastoma to HIV to celiac disease, and learned of a network of tweeps promoting LDN. 

The above tweet linked to a blog promoting LDN which is part of the Health Central community.

All this got me thinking about a bunch of issues; for instance:

• Does the promotion of off-label uses by a member blog comply with the HON Code, which has been adopted by Health Central?
• Since folks are already using social media to promote off-label uses of prescription medications, what are, and what should be, the obligations of pharma companies to address the information put out by such folks?
• Should we expect any of those obligations to change post-#FDASM (i.e., after the much-anticipated public hearing at the FDA on the use of social media in pharma marketing and subsequent anticipated rulemaking)?   
  

Well, marketing of drugs for off-label uses is supposed to follow certain FDA rules — not very restrictive, and essentially self-policed, since the rules just say that only medical journal articles on off-label uses may be shared with docs. Of course, some drug reps cross the line, and one pharma company — Allergan, the maker of Botox — is seeking to have even these limits lifted as unconstitutional limits on free speech.  These rules apply to the pharma companies' reps, not independent bloggers, of course, but the HON Code (which ought to apply, given the Health Central endorsement of the blog in question) ought to impose some relevant standards.  Consider  Principle 5 – Justification of claims:

All information about the benefits or performance of any treatment (medical and/or surgical), commercial product or service are considered as claims. All claims have to be backed up with scientific evidence (medical journals, reports or others).

Pharma's concern about content created by others but posted on a pharma company web site or blog or other social media site should perhaps be extended to a concern about content posted by others on other sites.  Both may be found just as easily, given the plethora of web search and alert tools now available.  I am not suggesting that pharma companies be called upon to monitor the entire internet; rather, perhaps the time has come to create firmer rules about promotion of off-label uses of prescription drugs, to be enforced by state and federal authorities.

Without waiting for the public hearing to be completed and rules to be written (which could take a year), many pharma companies have already established a social media presence.  While the manner in which they use the medium is a topic for another day, we should expect at least some of them to become more actively engaged in social media in the future.  

David Harlow
The Harlow Group LLC
Health Care Law and Consulting