Last April, the FDA issued letters to 14 pharma companies for failure to present risk information in paid search placements. New draft guidance on presenting risk information for TV and print followed in May, but guidance on online promotion remains wanting. Acknowledging the need for specific guidance about online promotion and, in particular, social media, the FDA called a public hearing in November to collect feedback and recommendations. More than 60 groups presented during the two-day hearings, and written comments were collected through February 28. DDMAC says the agency will review everything, and though they won't commit to a timeline, there's hope for guidance late this year or early next.
The uncertainties about social media engagement boil down to accountability and responsibilities with monitoring, reporting adverse events and presenting risk information, influence and sponsorship. Despite regulatory uncertainties, consumers are discussing all manner of healthcare issues in social media channels, and it's critical for companies to engage there.
“It's the absolute expectation of all consumers that they'll be able to interact with your company and brand at any time,” says WEGO Health CEO Jack Barrette. “Social media has accelerated that. Marketers are never going to go back to a world of one-way conversation.”
Bob Pearson, chief technology and media officer at WCG (formerly WeissComm Group), notes that not using social media is counterproductive to the advancement of public health information. He adds that the FDA's mission states that it's responsible for advancing public health by helping the public get accurate, science-based information.
“The people who have that information are the experts—the companies that make the products,” he says. “We cannot keep the experts on the sidelines. We have to let the experts share their expertise, and we have to allow dialogue. People learn through conversations and through sharing information with peers and asking for opinions. They need accurate information to do that.”
Companies such as Johnson & Johnson, Novartis and others have been pioneers in developing social media programs. At its core, social media communication is really just DTC communication. When you're ready to execute, follow existing principles and FDA guidelines and take cues from established social media programs. If you're concerned about a program or action, get pre-approval.
“Even if the FDA issues guidelines tomorrow…companies still have to apply their own judgment and common sense,” says Fabio Gratton, chief innovation officer at Ignite Health. “There's nothing to say you can't clear things if there is a risk-averseness. People just don't do it very often.”
Before executing, experts advise listening, noting that it's an essential precursor to social media engagement.
“Monitor perception, facts and misinformation,” says Barrette. “The regulatory concern is that companies might come across adverse events if they listen too closely. Most likely, companies are going to be required to monitor adverse events online anyway, and they'll learn so much from doing it. The misperception is social media will unleash a flood of adverse events reporting, but the facts aren't there to support it.”
If there are concerns about overwhelming adverse event reports, Barrette suggests starting small by monitoring a specific therapeutic area. He says many companies have found that the volume really isn't overwhelming.
Consider how you want approach resources, expertise and processes. Develop internal policies and guidelines, and educate and train internal stakeholders. Some companies feel more comfortable establishing a corporate social media presence instead of a brand-specific presence at first.
Pearson notes that it's important to look at the full social media landscape, and think about how each channel best serves you before you engage.
“Know where your customers are, how they interact and in what ways they want to interact,” he says. “Be customer driven when you make decisions.”
Once established on social media channels, poll audiences and ask them for ideas. Don't assume communication has to happen in real time. There are many ways to control flow of information, including screening user-generated content.
“Moderation is the most powerful tool pharma marketers have,” says Barrette.
On Twitter, Barrette suggests watching conversations for 30 to 90 days and then determining the 20 most useful things you can contribute before engaging. He also advises pre-writing tweets.
“Watch for opportunities where it's absolutely contextually appropriate to deliver a tweet,” explains Barrette. “The key is delivering where it's relevant and appropriate. This isn't a broadcast. When the conversation gets to a point where someone would benefit from your message, deliver it then.”
Pearson advises leveraging content you already have in channel-appropriate ways. For example, use Twitter to expand your news flow by posting information that you're already disseminating publicly. Avoid repurposing existing websites on Facebook, and don't use stilted language or regurgitate corporate messaging in any social media channel.
“It's better to listen longer and decide how to conduct a personal conversation that fits your guidance than to spit out corporate messaging,” says Barrette. “Don't use a company logo as your presence. Use the face of the person who's writing for you.”
Barrette notes that consumers are increasingly using video to learn, and Pearson suggests devising ways to use video in ways that are easy for consumers to digest. Pearson points to J&J using YouTube for Q&As related to surgery.
Pearson also thinks direct messaging on Twitter is an underused way to reach key influencers. Pfizer, he says, is a great example of using Twitter wisely. Be sure to identify and target online healthcare activists who have broad influence over consumers. Barrette recommends engaging with 20 to 50 of the leaders and developing programs tailored to them.
“Give them information that's valuable to them so you're bringing quality, regulatory approved information into the social media world,” he says. “Design an educational program for them. Give them a chance to write for your newsletter or become guest hosts on your Facebook page or chat on your Facebook page.”
Whatever happens regarding FDA guidance, Pearson notes that it's important to acknowledge that the entire online universe is continuing to evolve.
“If the FDA and companies are going to enter the conversation and educate, they have to reach people in the way they want to be reached,” says Pearson. “We don't want to regulate ourselves into irrelevance.”
Gratton adds that the spirit of social media is one of openness and transparency.
“Even among agencies, there's sharing that wouldn't have been done five years ago,” he says. “The only way this industry is going to move forward is if companies share experiences, such as how they thought through social media engagement, developed policy and processes, created buy in and brought in resources.”