Former FDA official: don’t expect much guidance on social media

“If the industry thinks the FDA is going to come out with thoughtful and complete guidance on how to use social media in 110 different circumstances, it’s going be very disappointed.” This quote is from Peter Pitts who was associate commissioner for external relations at the Food and Drug Administration between 2002 and 2004 and helped draft the most current guidance on direct-to-consumer pharmaceutical advertising. He also testified at the FDA’s hearings on social media in the fall of 2009. Read his full interview here with Ms. Tobi Elkin.

In the interview via eMarketer Mr Pitts says:

The FDA is going to take baby steps to move forward. Those who think that they’re going to receive a document that answers all their questions simply do not understand the FDA process.  The most important thing to understand is that everybody, including the FDA, realizes that social media is where the people are. Drug companies want to engage with people on social media sites. But I think the key question is what is and what is not regulated speech. Regulated speech is generally a very specific thing. I don’t think anybody wants the FDA to say that all health-related communications on social media is regulated speech.

When it comes to guidance, the problem is that the FDA embraces ambiguity because ambiguity gives it tremendous power and elasticity to change its mind given the circumstance. What pharmaceutical marketers are doing is waiting to see what the FDA says and then they’ll act accordingly. However, if the guidance the FDA comes out with isn’t some King James version of the Bible that everybody’s hoping it’s going to be, and it certainly will not, the question then becomes, which marketers will step forward and choose to be more aggressive than they previously have been?

Just as I had predicted.  The FDA, as a science agency, is struggling with the difference between science and consumer behavior.  By taking baby steps, however, the FDA is in essence going to handcuff DTC marketing because most companies are risk adverse. Legal people are not going to sign off on any new social media initiatives without clear concise guidelines from the FDA.

This means that more and more consumers and patients are going to ignore DTC marketing efforts and look for health information elsewhere on the Internet including social media sites.   It means that a number of new health social media and portal sites will emerge and that the ones who can provide good credible information coupled with a great user experience are going to thrive.

The FDA, I believe, does not understand how consumers are using social media for health but more importantly they don’t quite understand their own role in ensuring both the quality and credibility of health information on any channel, especially the Web.