After the FDAs social media hearings, whats next?

Participants agree that, given the speed at which social media have taken off, guidelines will be needed before the end of next year.

Participants agree that, given the speed at which social media have taken off, guidelines will be needed before the end of next year.

Many of the speakers who presented at the much-anticipated FDA public hearing about social media and the Internet are hopeful that a new set of guidelines to govern online promotion will result from the meeting.


Fourteen members of the FDA were present for the hearing, most of them from the Division of Drug Marketing, Advertising, and Communications (DDMAC). For two days, they listened to presentations from pharma advocates, companies, service providers, government agencies, search engines, and trade media, 15 minutes at a time, and posed questions of the presenters at the end of each presentation. I think they definitely heard the amount of interest and passion and the amount of stakeholders involved in the debate, says Wendy Blackburn, executive vice president of Intouch Solutions, who spoke to the panel Friday afternoon. I would be surprised if they harkened back to 1996 and didnt come out with guidelines as a result. (To read Wendy Blackburns take on the hearings, see Social media and the FDA.) []


The FDA held a similar public hearing in 1996 but failed to produce regulatory guidelines for the Internet. The Internet was still a relatively new concept at the time, however, and it was unclear how pervasive it would become for medical information and Rx promotion. No one can doubt that now. This first step the FDA has taken is a huge step forward in getting those guidelines out there, agrees Craig Audet, vice president of regulatory affairs marketed products, sanofi-aventis U.S., who presented on behalf of sanofi-aventis on Thursday. The FDA recognizes that [pharma engaging in social media] is going to happen and is inevitable, and that its better that we do it in partnership and get the right information out there, rather than the industry finding their way in the dark and the FDA taking an enforcement approach.


The past two years have witnessed the meteoric rise of social media, from YouTube to Facebook to Twitter, and consequently a steady increase in the number of people searching for an online dialogue with pharma. Many pharmaceutical firms would like to engage with these customers, but the lack of FDA regulation governing that interactionand the concomitant issues of fair balance and adverse event reportinghas discouraged them. The purpose of the public hearing was to let the industry voice some of its concerns and for the FDA to draw consensus for new policy development.


Among those who presented were Google, Yahoo!, Eli Lilly, Pfizer, Johnson & Johnson, PricewaterhouseCoopers, Pharma Marketing News, WebMD, and PatientsLikeMe. On day one, John Mangano, vice president of comScore, presented information about the extent to which Americans use social media for health-related purposes. We felt it was important that a third party view was presented by a company that measures the Internet as a whole and whose whole purpose was to simply be that third party, says Mangano. One comScore study suggests that 53 percent of Americans use social media for health-related purposes. In the end it is proving influential in providing condition sufferers with communities to help educate them on their condition before seeing a doctor and help them prepare for discussions with their physicians on their condition, says Mangano.


Google presented shortly after Mangano and proposed a new way to present branded search ads that ensures fair balanceads would include links to both benefits and risk information within the context of the ad.


On day two, speakers continued to emphasize the emerging theme of the presentations: The Internet has become critical to the way consumers seek medical information and make health care decisions, and that in order for pharma to engage in this dialogue responsibly, they need regulatory guidelines. Bill Drummy of Heartbeat Digital pointed out that, according to a recent HealthCentral survey, only one percent of patients go through the hassle of reporting an adverse event to the FDA online. Drummy suggested embedding adverse event report links directly on branded websites.


Craig Audet of sanofi-aventis encouraged the FDA to look at the direct-to-consumer (DTC) broadcasting guidelines that govern television advertisements for a model for new online promotion guidelines. We dont necessarily have to reinvent the wheel here, he says. We spent a lot of time hashing out the DTC broadcasting guidelines. If you have a site where you dont have space limitations it might be appropriate to use a DTC ad-like approach, so that when you post product related information, you have to balance any claims that you make with pertinent safety and risk information.


On day one, John Mack of Pharma Marketing News suggested that, for sites like Twitter with space limitations, the FDA should create an FDA-designated hash tag to be posted alongside any branded Tweet from a pharma company. That hash tag, says Mack, would ensure consumers of fair balance.


Similarly, at the end of day two Wendy Blackburn of Intouch Solutions proposed a link called a prescription risk provision that the FDA would require to be posted whenever online space limitations precluded fair balance. Such a link would lead consumers to pertinent risk information. The reality is that some channels and mediums within the online space have very real space limitations, such as search engine ads, twitter feeds, and banner ads, says Blackburn. In those spaces where theres not room for fair balance, there should still be a way that pharma can communicate and is responsible in a very standard and consistent way.


By the close of the hearing, some 75 speakers had presented to the FDA panel, on whom the responsibility now falls to hash out regulatory guidelines. The FDA wouldnt comment about its takeaways from the hearing, but the general consensus is that, with the speed social media and the Internet is evolving, guidelines will need to be produced before the end of 2010. Its like this constant cycle, says Blackburn, unless guidelines are out now, by the time you issue them they could potentially be outdated. If [the FDA does] issue guidelines, theyll have to be broad enough to address future innovations.