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Issue Date: Firm Voice - February 24, 2010


Striking a Balance with Social Media Rules: How to Manage Social Media in Regulated Industries for PR Clients
If you like many firms, chances are that some of your biggest clients work in heavily regulated industries—from pharma and healthcare to financial services. For these companies, social media programs and efforts must be planned and executed carefully—otherwise, they run the risk of violating disclosure guidelines set forth by bodies such as the FTC and FDA. And, compounding matters, all public companies—and the firms who serve them—must be cognizant of SEC regulations when it comes to social media. After all, nobody wants to fall under prosecution for violation of RegFD.

So what exactly are the FTC guidelines with regard to social media usage? How is the FDA tackling social media regulation this year—and how should PR firms with pharma and healthcare clients plan accordingly? Where does the SEC stand on social media—and what rules must firms engaged in financial communications stay on top of to ensure they aren't in violation? How can account managers stay ahead of the curve when it comes to launching social media programs in client's regulated industries? The answers and more:

Michael Lasky

Michael Lasky,
Partner,
Davis & Gilbert

1. Do your homework—know the law. "Know what FTC requires for all industries, then know your client's specific regulatory compliance bodies at the federal and state levels," advises Michael Lasky, partner at law firm Davis & Gilbert, outsidelegal counsel for the Council of Public Relations Firms and chair of the firm's Public Relations Law Practice. "If you are a PR firm that does a lot of work with healthcare companies, you should know the FTC guidelines, plus what's happening with the FDA in this area. If you're in IR, then you should know the FTC guidelines, as well as what the SEC and FINRA require." Here's a quick overview:

  • FTC Guidelines: New guidelines were just published in October, says Lasky. "They now have the ‘impactive law' and basically make clear what bloggers and marketers should be doing in connection with an endorsement or testimonial about a marketer's goods or services." The key element here is disclosure, he says, "specifically disclosure of any material connection between the marketer and the blogger"—or any fact like the providing of free services or product that someone reading the blog would think would be material for that reader to evaluate the credibility and message being communicated by the blogger.
Gary Kibel

Gary Kibel,
Partner,
Davis & Gilbert

Gary Kibel, a partner in the firm's Advertising, Marketing & Promotions, Technology and Digital Media practices, adds this: "This is not just an obligation on the blogger—it's also an obligation on the marketer and those that are acting on behalf of the marketer, most notably PR firms. That means you should put a social media policy in place not to give out complimentary product to bloggers unless they agree with your social media policies. The FTC has said that the very existence of a social media policy will help in their determination of whether the firm has done anything wrong." (See tip three below for more on social media and blogging policies.)

  • FDA Guidelines: "Pharma and healthcare clients have very unique challenges. It's very difficult for these companies to participate because as soon as anybody mentions an adverse reaction to a treatment or medication, there are FDA requirements that lock in," says Kibel. "So, pharma has asked the FDA for guidance and they have said they'll provide some in the next six to 12 months or so."
Ritesh Patel

Ritesh Patel
Social Media Chief
Chandler Chicco

Ritesh Patel, who heads up social media at Chandler Chicco (a firm that focuses largely on healthcare and pharma clients), is more pointed and advises thinking twice before engaging with patients (or pharma product users) online, at least until Q4: "There is an FDA process for talking to people who use your product that involves first talking to the doctor, replicating an event—such as a side effect—and then reporting it. But there isn't a protocol in place for that if somebody posts something on a blog or forum that says they took a drug and something bad happened to them." The upshot: "The industry is hoping for clarity on this now, but it will probably be in 2011."

  • SEC Guidelines: "On the financial site there are regulations from the SEC, NASDAQ and FINRA to consider," says Kibel. "As with healthcare, financial services companies and traded companies have all been clamoring for guidance. The issue is that some statements must be pre-approved. So if you're on Twitter, do you have to do that to post a Tweet? That's the challenge. A good start with regard to guidance on this is the position paper put out by FINRA in the past few weeks."
Mark Eber

Gene Marbach
Group VP and IR Blogger
Makovsky + Company

Gene Marbach, group vice president and IR blogger at Makovsky + Company, elaborates: "There are disclosure regulations in place via the SEC's RegFD that already cover social media," he says. "Their take is to think of it as another media form—just because it's social doesn't mean you can skirt or violate already existing disclosure rules. Basically, it boils down to putting your material news out over the wires and it being broadly disseminated. Similarly, if your material hasn't been disclosed through the normal channels, you can't reveal it via social media." That said, Marbach expects an eventual liberalization of disclosure issues related to social media—but won't put a date on it.

So what's his advice? "While you might not ever be prosecuted for violation of RegFD, you can help the corporate reputation by creating an environment of compliance via a social media policy, thereby showing that your staff plays by the rules," says Marbach. "This gives you protection in event there's inadvertent disclosure—the SEC can then say you play by the rules and it was mistake. If you foster that environment of compliance, you may get a pass."

He also reminds readers that you should include the same standard disclaimers in social media that you use in other communications channels.

2. Recognize that FDA regulation also impacts search. "Health and pharma clients and the PR people who service them also should know that the FDA held hearings in November and one of the big points that came out of it was that the methods for treating search and search results as proposed by Google will be changed this year," says Patel.

What does that mean to you as a PR professional? "More PR people are releasing social media releases and press releases catering to search engines. So, we'll have to be careful with what the search results display when someone searches for a term or phrase in the pharma and healthcare sectors," says Patel. "That basically means that you can't be misleading in health related search. Questionable practices could run into FDA regulatory challenges when they release guidelines around this in Q4."

Patel adds that Google made a presentation during the hearings showing the pullback of spending on search advertising that came from the pharma industry immediately following an earlier incident in which the FDA issued warning letters to a handful of pharma companies related to their search advertising practices. "The loss was in the hundreds of millions of dollars," he says.

3. Post social media policies and look at best practices. Marketers should institute written policies and procedures concerning the rules by which their employees engage in social media participation, say Lasky and Kibel. At minimum, a blogging policy, for example, should:

  • Include permitted conduct, encouraged conduct, prohibited conduct, the company's rights and remedies.
  • Educate employees not to violate others' intellectual property rights (copyrights, trademarks).
  • Prohibit disclosure of confidential information.
  • Ensure that discussions regarding competitors are not overly-negative.
  • Prohibit employees from posting any objectionable content.
  • Educate employees to disclose that their statements reflect their own opinions, not the company's.
  • Ensure that employees disclose their connection to the company when posting about its products or services.

Marbach advises looking to companies like Dell as models of what to do. "Not only do they leverage social media smartly for financial communications, but I also recommend reviewing their social media policy online," he suggests.

John Bell

John Bell
Managing Director/ECD
Ogilvy PR

4. Train, train, train. "We train all staff regardless of practice area explicitly on FTC and FDA guidelines," shares John Bell, who is managing director/ECD at Ogilvy PR. "The FTC has guidelines and the FDA is exploring this issue. So, understand the current intent of those and keep staff up to speed." So what does that training look like?

"We have the ‘Ogilvy Social Media Outreach Guidelines' that include a step by step process for outreach in relation to FTC guidelines on testimonials and endorsements. We hold webinars across the agency and for clients on that content. We also circulate those guidelines as backup and in between sessions," Bell offers by way of example.

The firm also offers the training for clients, Bell notes. "However, in addition to webinars, we also customize documents for clients so they're tailored to how their organizations are set up." As you will find, he says, it's not one-size-fits all when it comes to social media regulation.

5. Get specific—offer agency case studies. "A key component to FTC guidelines is all about disclosure," stresses Bell. "So what we have done is to go further and articulate exactly how we do best practice disclosure on Twitter, blogs, message boards and so on. We illustrate everything with real world case studies. We do this because the devil is in the details when it comes to how you execute on and meet the expectations of FTC guidelines—like where to put the endorsement statement and how it is phrased." In fact, Bell says the biggest mistake firms make is not being explicit about how exposure is handled. "People really fall down on this," he warns.

6. Seek association and outside support. "We use our membership in WOMMA to sharpen our understanding around this," continues Bell. "There are working groups around FTC and FDA guidelines at WOMMA. For example, we'll have Tony Duresta, our WOMMA attorney of record, and the FTC at our events and they will help us prepare ourselves for self regulation, which is preferable to regulation from a government body."

7. Don't be reactive—practice self regulation. "We have the information we need to lead self regulation to the benefit of the brands we work for," he says. "Therefore, we can avoid the need for any further government regulation—so let's do it," he encourages. The point: "Don't just follow the letter of the law. Be proactive and get ahead of it. Take the lead at your firm and with your clients."

Bell's additional tips:

  • Codify, codify, codify: "Create explicit social media outreach guidelines for staff," advises Bell, echoing Kibel and Marbach's earlier points.
  • Lead by example: "Communicate from the C-suite and senior leadership to the entire organization, not just to the social media team, what the key four of five compliant pillars are of your FTC guidelines," says Bell. "Emphasize that it's serious,
  • Go public: "It would be helpful if the agency were to publish publicly their own terms of engagement—their promise of what they will and won't do," Bell adds. "Similarly, state publicly and wherever relevant (websites, etc.) that not only do you have your own promise around this, but that you're also compliant with WOMMA or other association guidelines.
John Senak

Mark Senak
SVP
Fleishman-Hillard

8. Recognize that the pace of usage outstrips regulatory ability to respond. "Ten years ago, Google had eight employees. Facebook and YouTube only got their domains five years ago and Twitter has been with us for only three years—and yet there were1.2 billion tweets in January," says Mark Senak, SVP for Fleishman-Hillard and author of the "Eye on FDA" blog. His point: "The FDA on the other hand is huge behemoth and doesn't move quickly. Events have outpaced its ability to regulate this."

In March of last year, for example, the FDA hosted a podcast on social media that included Senak. Not only was this their first event addressing social media, but their message was basically this: "It's not the medium, it's the message. If you wouldn't send a message in broadcast or print, it's not a message you should use in social media." What that fails to take into account, says Senak, is that there's tremendous nuance in social media that doesn't appear in print or broadcast.

9. Avoid the common mistake of sitting on the sidelines while regulatory issues get sorted out.  "We have seen a lot of pharma companies let the fear of regulation stop them from engaging in social media—as opposed to adopting their own standards within the regulations already in place," says Bell. "Don't let that happen to you or your client. Get in front of this," he advises.

Senak agrees: "Companies are fearful about possible FDA warnings and later regulations—and so they're waiting to see what everybody else does. That's a huge mistake. If you look at shared media, brands are being shaped there more than any other media segment. Lack of involvement means you are hurting your brand." His suggestions then:

  • Watch and emulate best practices: "It will vary by culture and industry. But there are leaders out there who have pushed the envelope in social media and gotten no action letters yet," encourages Senak. "So it's a matter of assessing and combining existing and relevant best practices. For example, Johnson & Johnson has an extremely active YouTube channel, blog and Twitter presence. They've been very careful not to mention products and are a good model to follow."
  • Revisit messaging: "You can also make reasonable assessments as to where the envelope can be pushed. There are a lot of companies in traditional media that trip FDA wires by not including risk information. So look at what the FDA said originally—‘It's not the medium, it's the message'—and review your messages to make sure they don't violate the four corners of any of the areas regulated by FDA as off bounds, like inclusion of risk information or making unsubstantiated claims. Self regulate and reassess you core messages outside of social media first."

 

What Do Wikipedia, Medpedia and Google's Sidewicki Mean to Pharma Clients?

Wikipedia and Medpedia pose new challenges for healthcare and pharma companies, says Mark Senak, SVP for Fleishman-Hillard and author of the "Eye on FDA" blog. "These are sites where someone can write an article about your product with misinformation. So, if you correct that, are you liable for that whole entry from an FDA regulatory standpoint, or is it now promotion?" he asks. "These the new questions we need to address."

Even more alarming: "In the third week of December, Google launched Sidewiki, which allows anybody to go to any site and install a sidebar that is a wiki," Senak says. "Suddenly, what was a 1.0 static website has been converted into a Web 2.0 social media tool that you don't control. Anyone can go to your site and write on it and read it on your site. Your webmaster can't delete or change it."

So, if you have a product site (and this could be true for financial services, as well) and someone writes that the product not only "cured my cancer, but my toenail fungus"—that's an off label use, which falls outside regulatory allowances. But the company didn't generate it and didn't ask anybody to write it—and it's connected to your site. "Should you correct the misinformation with the correct link or let it stand? What's the right thing to do?" asks Senak. "We don't know because FDA hasn't issues guidance yet."

He adds that since the launch of Sidewiki in the third week of September, 18 companies in the healthcare and pharma sectors have had Sidewikis put on their home pages.

Comments:
Wednesday, February 24, 2010 10:19:28 AM by Paula Lovell
So here's a burning question for this panel: If you are a hospital with a Facebook page and someone comments and uses PHI (like: "My brother, Bob, had his open heart surgery there and he is doing great.") is the hospital liable for the release of this PHI?

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