That apprehension came to a head in April when FDA sent 14 warning letters to various pharma companies citing inappropriate
online text/link advertisements. According to the complaints, pharma companies could not include a brand name in the same
ad with a disease state without including risk/benefit information. The problem is that it's next-to-impossible to include
a risk statement in an ad that's just three lines long. The assumption was that as long as the link led to a page with the
risk info, the pharma company was in the clear. But FDA made it clear that pharma can't assume anything when it comes to social
This was not an issue about social media, but actual marketing. However, if FDA is going to get testy over simple link ads,
imagine how it will react to conversations about adverse reactions on Facebook.
When approached about participating in a social media forum, FDA declined to reply. Rather, the agency issued Pharm Exec a vague e-mail about how it monitors the Internet for improper promotions. This suggests that FDA may not be ready with a
strategy to address overlaps within the regulatory space and create a pathway for oversight of social media initiatives by
the prescription industry.
"Regarding whether specific proposed pieces comply with the regulations, we have a process in place that allows companies
to submit their draft proposals for our advisory comments," FDA spokesperson Karen Mahoney states. "This allows them to receive
our advisory opinion on the piece, and correct any regulatory issues with the piece before public dissemination."
Alexandra von Plato, chief creative officer at Digitas Health, suggests that FDA should tackle the uncertainty head-on by
creating a public forum or developing guidelines for social media. By allowing the public to interact with pharma and FDA,
the agency could help foster understanding of the kinds of information pharma should be providing in the social media space.
"Companies are experimenting with [social media], but it's like wading into unfamiliar waters," von Plato says. "You take
a risk-averse, conservative industry and put them into a situation like that, and you're not going to get a lot of really
meaningful conversations. The demand is there, but there is a barrier."
The question is: How can pharma engage in social media in a meaningful way that conforms to the regulatory confines set forth
by the FDA?
"People need to have cooler heads," Kerins says. "Instead of complaining that FDA isn't giving [industry] guidance, there
must be a level conversation. I've talked to the communications folks at FDA who say they are very interested in looking at
this issue to create more certainty around what is legally appropriate and what is not. I can imagine that FDA is in a similar
spot as us." In short, all parties stand to benefit from establishing some basic ground rules.
Google has had discussions with FDA to create pharma-specific ad formats that will satisfy the concerns about fair balance
and ensuring that the public is not misled. "Search advertisements drive the bulk of traffic across different search engines
to company Web sites so they are still incentivized to working with us," Patel says. "If you build a site and you don't drive
traffic there, then it's just going to sit there, and no one is going to find it."
Listen to This
Rather than bury their heads in the sand or stick to only the safest forms of social media, a few companies are actually evolving
their communications strategies to better employ these new tools. While everyone is playing the Facebook game, three pharma
companies in particular are taking social media to the next level—and they're doing it through some pretty interesting methods.
While pharma might not be able to reach out to consumers directly, it can use the Web to listen to patient conversations in
order to gain insight into how people are dealing with diagnoses, and identify the support they need. Companies can then enhance
existing programs or build new solutions based on what they discover.
"We used to mostly talk about the drug, and now we help our clients talk about what people need to know about their diseases
or how to find more information," von Plato says.
Digitas is trying to make its clients stop thinking of the Internet as a promotional tool to sell products and messages, and
to start using it as an opportunity to engage patients and use the technology for customer service strategies. The company
told Pharm Exec that it has created a tool that automates the information gathering process. In layman's terms, Digitas uses manpower to
find out where particular groups are residing online, and then uses a series of algorithms to automatically feed pertinent
data into its own database.
This might sound a little Orwellian, but Digitas insists it's a great way for pharma companies to sort through all the conversations
and find information pertaining to adverse reactions, questions about treatment, or a particular disease state. "We've pulled
out a good number of insights from these listening exercises, and the information filters back into RM programs and helps
refine the language in email campaigns," says Sarah Larcker, senior manager of strategy analysis at Digitas. "For example,
moms with children with asthma refer to inhalers as puffers. We want to talk to moms in their language, such that our messaging
and the support we provide resonate with them."