The Op-Ed: Do FDA Social Media Rules Still Matter?
6 CommentsBy Ed Silverman // December 15th, 2011 // 8:12 am
There is an old adage that, in the absence of information, a vaccum is created. And not surprisingly, the pharmaceutical industry is struggling to fill a void concerning social media. Having failed to deliver more than once promised guidelines, the agency is now in the position of watching - deliberately or otherwise - events overtake its regulatory instincts. Brian Reid, a director at WCG, an integrated communications firm, and a social media maven, notes that the FDA may have failed us.
More than two years ago, before Facebook was a movie and before Twitter had a business strategy, the FDA held a long-overdue public meeting to solicit input on how the agency should regulate the way that industry connected with professionals and patients using social media. The expectation was that the FDA would move quickly to begin codifying rules, allowing companies to use all the tools at their disposal to share important public health information.
But the guidelines didn’t appear in the wake of the meeting. And they didn’t appear by the end of 2010, despite an unofficial FDA deadline to push something out by New Year’s Day. And then the agency missed another deadline, this one on March 31. By mid-year, FDA officials said they would stop setting deadlines.
Despite the delays and the growth of social networking tools, interest is waning, not growing, in new FDA rules governing the social space. Companies have, by trial and error, begun to establish some excellent models for bringing accurate information to those that could benefit. No major drug company lacks a blog or a Twitter account; Facebook pages are becoming more standard. There are patient information portals. Establishing rules would probably do little more than codify the approaches that industry has already figured out.
To be sure, there are some areas where guidance remains crucial. For instance, rules governing how companies present risk information remain hazy: is it OK to mention products on social networks (and elsewhere on the web) with only a link to the prescribing information? What about a link to the product web site, which then – in turn – leads to the detailed risk information? There are hints about how the agency views such questions, but the FDA has never been explicit. And that lack of precision – combined with the legal and regulatory risks of running afoul of the FDA on matters of promotion – has dulled the motivation to innovate.
This would be just garden-variety frustration at the pace of bureaucracy if it hadn’t put biopharma at a disadvantage in the market for health information. During the two years in which industry was feeling their way to a set of conventions, pseudo-science and quackery has continued to grow on the web to the point where we’re seeing the largest measles outbreak in at least 15 years and where parents are swapping dangerous viruses via the mail. New rules would not have instantly created a counterbalance, but clarity certainly would have unshackled subject-matter experts in industry at a time when additional education was sorely needed.
With the advent of patient-centered “participatory medicine” poised to become one of the century’s great trends in health care, it’s more vital than ever that consumers have access well-vetted health information, available via where they live, online. The biopharma industry has recognized this, which is why so many companies have opted to take the risk to push ahead despite the lack of guidance. As 2012 dawns, patients have more medical detail available to them than ever before, with more resources on the horizon. But we could have been here sooner, and that’s the FDA’s real legacy in social media.
John Kamp
Great comment.
Of course, the FDA guidance will matter. But, more important, the industry must point the way. Congratulations to the companies that are forging the way, and to the Digital Health Alliance for efforts to develop good practice principles and encouraging us all to participate.
John Kamp
Coalition for Healthcare Communication
MsPiggy
This editorial piece plays blind cheerleader for Big Pharma…”critics are spreading dangerous quackery”..”pseudo science rules the internet”….please notice…Brian Reid, a director at WCG gave an depression influence list link which included many sites that are industry funded directly or indirectly by the pharmaceutical dollars, and clearly propagate their sales message continually…
do we need more cloudy rules that Pharma will manipulate & the FDA is incapable of enforcing in a never ending quest to $$SELL PRODUCT$$…Because when you get past all the bravado about health information and direct engagement with consumers through social media….The bottom line always comes back to $$SELLING PRODUCT$$…expecting or to ask that the FDA to bring clarity or any workable solutions to this arena goes far beyond their capability or expertize…this unfortunately should be left to those bought & paid for industry bumblers in congress to deal with…
The reality is that the FDA has shown to be fairly inept or less than capable of regulating those industries even with basic drug and food safety consistently…and now it’s those that clearly have a financial stake in the game that are clamoring for the FDA to set guidance regulations for social media…
In my opinion the only rational & reasonable step the FDA should take in this situation is to BAN the Pharmaceutical Industry from anything more than they already are doing in other public communication venues: (note: I also strongly believe that pharmaceutical industry direct to consumer advertizing should be banned in the best interest of public health and safety). That statement always ruffles a few feathers….lol
The industry already spends billions each year in advertizing across print mediums, through the air ways, and TV; it’s not as if they haven’t mastered the art of promotion, or are not the controlling influence peddlers in almost all of medicine, advocacy, higher education, media, and research already..is anyone going to stand up & somehow make an argument that they not getting their message out!
The whole issue of Pharma being placed at disadvantage in social media is so ludicrous & laughable it really borders on total insanity (they have a pill for that you know)….but then, that is what always happens when you have so much money in play…
Dave S
There is a huge opportunity for pharma to safely get involved in social media platforms and not anger the FDA. However,the industry needs to use these tools for the manner in which they were created. That is to communicate and not market. It’s a fine line that will take dicipline not to cross. We know that health activits want to embrace pharma so their followers can be well informed…just not sold or targeted. While big pharma may be tempted when they see Nike pushing new shoes or Apple promoting the latest ithing on social pages, they need to remember that nobody has ever died slipping on a pair of Air Jordans or downloading software. Unless of course, you’re texting while driving. But there’s no explaination for stupid.
Jason Boies
Funny you mention the industry being the ones to point the way, John.
Just today I stumbled across this link courtesy of the folks over at Webicina. It’s the “Open Access Social Media Guidelines for Pharma”. It’s not from the Food and Drug Administration but it represents an attempt to provide best practices for the industry both in general and for specific platforms (eg. Twitter, Facebook).
http://scienceroll.com/2011/12/15/open-access-social-media-guide-for-pharma-on-webicina-com/
Worth a read to be sure
Cheers
Jason Boies
Radian6 Community Team
Former FDAer
I submit that there is NO vacuum…no absence of FDA guidance on how Pharma can use social media. The guidance exists in the form of the regs, enforcement actions, the FD&C Act. The issue is, in my opinion, that Pharma doesn’t like the guidance. They don’t want the cumbersome risk disclosures that come with product mention..
Also, this notion of Pharma needing to come to the aid of patients to protect them from “quackery”…I don’t buy it. Not an excuse for getting dispensation from following existing promotion regs. Let’s remember, People…Health info seekers have to take responsibility for acting on info they find… to remember the phrase- “buyer beware”- and to consider the source of health info they read on the net. If they want credible info, they know where to go to find it.
Ritesh Patel
Totally agree with Former FDAer, as long as major corporations view Social Media as a marketing platform, the rules are in place and are actually quite good. DDMAC etc are very clear of the do’s and dont’s of promotional materials. They apply to Social too.
However, I would suggest that if the argument is about engaging in a dialog and ensuring that relevant and science based facts are being provided to educate folks using this medium, then the onus is on the marketer to think like a neighbor and friend and not a seller. The halo effect is huge. Look at the Coca Cola fan page as an example. Self regulated by the people for the people, with Coke providing great content.
Disease awareness programs are perfect for social media and if use properly (not marketing, more education) can prove to be very valuable in educating the patients.
I believe the FDA did the right thing around search (fair balance needs to be showcased on a search ad) and now are doing the right thing around Mobile. I believe the rules that we have in place for promotional and marketing are right for exactly that.
Ritesh