Many of you know that the FDA held public hearings on the pharma industry's use of Social Media mid-last-month.  There was much excitement going into this because to date, the FDA has pretty much dodged the subject, and left drugmakers in fear of retribution (see BusinessWeek's summary here).

Essentially, since there are no clear rules laid out for how pharma can and can't advertise their wares online, and talk about them on blogs, social networks, Twitter and the like, there's simply been a haze of confusion and a lot of reluctance to engage.

So what came out of these long-overdue hearings? Nothing Earth-shattering yet, it fda-hashtagseems, other than public recognition that the Internet is unlike other forms of media (duh) and therefore merits its very own guidelines.

After two full days of hearings and 70+ presentations, it seems that the FDA, and all the interested parties, are still in information-gathering mode at the moment.  FDA officials have apparently told John Mack of Pharma Marketing Blog, who attended the hearings, that new formal guidelines are likely to be published by the end of next year.

To help things along, John Mack and Fabio Gratton, Chief Innovation Officer at a healthcare marketing agency called Ignite Health, have been working together to collect a list of questions for the FDA, posted online here. They plan to organize the questions into categories before submitting "a thorough list" to the FDA.

"Realistically, the Agency might not be able to answer all the questions, but we believe any answer will provide us with more insight than we have now. It certainly will help FDA understand our concerns," Mack writes.

Here the main items the FDA needs to address, IMHO:

  • Stating whether the FDA considers bloggers to be journalists, and do the same engagement rules apply that are currently in place for vendors' interaction with mainstream media?;
  • Creating new, more realistic requirements for the obligation to 'report adverse events' on web sites where the proliferation of user-generated content may render it impossible to follow every such instance individually (especially with advent of new Side Wikis - which allow users to comment on ANY website, without the creator's involvement);
  • Sanctioning or setting clear rules for placing ads on social media web sites that display user-generated content;
  • Creating clear-cut disclosure rules for both bloggers reviewing products, and for vendors generating content—such as comments, uploaded audio and video—on social media web sites;
  • Likewise, creating clear rules for employees of regulated companies on the extent allowed, and nature of, their engagement in social media web sites (i.e. can they blog themselves, post comments, etc?)

It seems most of the talk at the hearings was about the specifics of online advertising.  Some participants made concrete suggestions on ways to protect consumers from covert commercial campaigns:

* Google suggested a new way to present pharma-branded paid search ads that would include links to both benefits and risk information within context of the ad, in order to achieve "fair balance." More on this at EyeOnFDA here. Mack thinks the FDA will sanction this idea as one of its first-ever Internet-specific guidelines.

* An advocacy group called PhRMA is calling for a universal safety symbol — either the FDA logo itself or an FDA-approved symbol — to indicate that a Twitter or Facebook mention links to a page that contains the pharmaceutical company's FDA-mandated risk information.

* John Mack himself proposed something simpler: the use of a special hashtag for branded Twitter posts, that would flag these posts as the promotional fodder they are.

Finally, Mack writes about the sense of urgency palpable from the pharmaceutical company presenters. "The industry is worried about the vast amount of user-generated health information and resources on the Internet. The industry's share of voice on the Internet — especially the social media part of the Internet — is rapidly be dwarfed. Drug companies worry about that and they see that they need to get into the conversation. Guidelines will help them do that."

Hmm, a little disconcerting considering that all of this is supposed to be about protecting consumer/patients like ourselves.  No urgency from the FDA's side on this? They certainly haven't shown any to date.

However, I do recognize that good things take time. As one Common Sense blogger writes: It's important for the FDA to create guidelines that can evolve with the medium, rather than just placing increasing constrictions on it.

Thoughts from fellow D-bloggers and all of you diabetes ePatients out there?

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