As of Monday, August 15, drug companies can no longer bar comments from their Facebook pages. The conversation is now open, and Facebook users can freely comment on drugs, regardless of their knowledge and use of the drug in question.
Ostensibly, this seems fair. Drug companies should play by the same rules as the rest of companies, right? But if drug companies should abide by the same Facebook rules, they should be just as free from government regulation as are other companies whose pages feature third-party wall posts. Unfortunately, this is not the case. Comments on the walls of drug companies can expose drug companies to serious liability with the FDA – liability that could cost hundreds of millions of dollars.
Potential liabilities present themselves in two forms: First, drug companies are required by the FDA to report all complaints of adverse drug effects. Does this extend to the hundreds or potentially thousands of comments that could be written on the walls of drug companies? Defenders of the current FDA policy argue that there are relatively few such complaints currently posted to walls. But if social media has taught us anything in the past ten years, it’s that we should prepare for exponential growth. It’s also said that even if the number of posts increases dramatically, the vast majority of the posts will not qualify as complaints that must be reported. Maybe so, but how’s a drug company supposed to know which complaints merit reporting if they don’t spend thousands of hours checking each wall post? As noted by AstraZeneca spokesman Ton Jewell in The Washington Post: “We’re very strongly committed to social media, but we have to make sure that the amount of time and resources spent on [monitoring it for problems] is appropriate.”
The second liability comes from FDA’s prohibition of “off-label” speech. This ban precludes drug companies from truthfully advertising uses of their drugs for purposes beyond what the FDA has approved. The “off-label” world is already labyrinthine, but Facebook comments threaten to make it even more complex. What if a Facebook commenter suggests that a certain drug be used for a non FDA-approved purpose? Does this count as off-label drug promotion? Does the drug company have to delete this comment? If so, how quickly must the company remove the post? Or is the company in trouble for the post’s appearance, no matter how quickly it’s removed?
Due to these concerns, several drug companies have already have already deleted Facebook pages for certain products. Johnson & Johnson closed four pages and AstraZeneca closed one page. See The Washington Post, SF Gate, and the Pharma Times for more details on the reactions of drug companies.
The fewer Facebook pages there are, the less truthful information will flow to patients. This is a lose-lose situation. Only the FDA can fix this problem – it must immediately issue new social media guidelines for drug companies, something as we have pointed out previously FDA continues to put off. These rules should be much clearer and far more permissive of truthful speech.
For more information on this subject, see these two WLF publications:
- FDA Social Media Warning Letter: A Fragmented Approach To A Comprehensive Problem by Kellie B. Combs of Ropes & Gray LLP
- Online Pharma Marketing: Lack Of Clear Rules Compels Caution On The Web by Joseph P. McMenamin of McGuireWoods LLP)