OR WAIT null SECS
© 2023 MJH Life Sciences™ and Pharmaceutical Commerce. All rights reserved.
Following FDA’s punt of regulations for social media, industry is scratching its collective head over how to utilize these channels
Take one of the most dynamic transformations in any form of media occurring right now—the rise of social media like Facebook, Twitter and the rest—and factor in that marketing and advertising agencies themselves are heavily vested in exploiting the possibilities of the new, digital cornucopia. Then layer in the reality that almost month by month, the “norms” of social media (if such a concept can be recognized) are changing. Now throw this tidal wave against the careful, deliberate traditions of FDA regulation of healthcare communications.
The result: a lot (a LOT!) of sound and fury, but relatively little movement by pharma companies into the social sphere. FDA, without coming right out and saying so, has postponed providing rules on pharmacos’ use of social media (and has indicated that it is likely to provide “guidance” rather than actual rules). In turn, pharma marketing and communications leaders are dabbling around the fringes of the social media movement, while mostly building more websites and buying banners through online marketing networks. Behind the scenes, though, pharmacos appear to be quite active in monitoring online discussions and commentary—itself an evolving type of marketing service for themselves.
Living without guidelines
In 2009, FDA’s Div. of Drug Marketing, Advertising and Communications (DDMAC) held public hearings over online marketing and communications (Pharmaceutical Commerce, Nov/Dec 2009, p. 6), which brought out many thought leaders among online companies, public interest groups and manufacturers. DDMAC hoped to use the commentary to develop communication standards in 2010, but at the end of that year, delayed them to this year. Social media, as such, were somewhat on the periphery then; a lot of the discussion revolved around getting fair balance into banners (which, it turned out, has become fairly easy to do). But one issue that was prominent then—and remains so today—is whether manufacturers are obliged to handle product complaints that might be expressed anywhere on the Web as reportable adverse events (AEs).
In January, the agency dropped online drug promotion, including social media, from its Guidance Agenda publishing plans for 2011, leading industry watchers like John Mack, the blogging “Pharmaguy,” to ask, “Is this supposed to be the promised guidance we’ve all been waiting for?”
For its part, DDMAC is keeping its cards close to the chest. “It is difficult to provide a timeframe for the issuance of our guidances or related ‘milestones’ due to the extensive work and review process, or GGPs [good guidance practices],” DDMAC announced in a letter. “Our goal is to provide well vetted, meaningful, and useful guidances articulating our current thinking on various topics related to Internet/social media promotion.”
Asked whether he thinks the FDA has given-up on the effort to produce guidelines, James Musick, director of social media and web communications for Genentech, says “the more I dig into social media, the more I find that it’s extraordinarily complex. So I don’t think it’s so much a back-burner issue for the FDA as it is that they’re realizing what we have realized, which is that it’s not easy to do.”
For now, he says the company is taking a “letter-of-the-law approach,” even he’s left wondering which letters to which laws to follow. Like most pharmacos, Genentech has a public statement of principles, based on parent Roche (see box, p. 34). Most of the rules are not specific to social media, except to note that comments posted in a seemingly local or private site have a way of ricocheting around the world.
Marketing agency leaders say that it’s just as well that DDMAC hasn’t come out with rulemaking, simply because the medium is changing so quickly. In just the past few months, for example:
• Google announced that it was shutting down Google Health, an early effort to get electronic health records (EHRs) organized for consumers; at the same time, it has started up Google+, its answer to Facebook.
• Microsoft, which has a service, Health Vault, that competed with Google Health, has gone ahead and acquired FDA registration for the service as a medical device.
• In April, Facebook announced that it would no longer allow users to disable comments, a rule that already affects new Pages and coming to existing pages by August 15, according to numerous agency sources. Matthew Snodgrass, director of social media for San Francisco-based agency WCG, was one of the first to dissect pre-announcement details and note the exceptions that will apply to pharmaceutical companies:
• Pages that promote, talk about, or support prescription drugs or devices
• Pages that focus on a disease state where there is only one prescribed treatment (even if the Page doesn’t mention the treatment)
• Disease-state/therapeutic area Pages that have the PI/ISI on the Page
This means that corporate Pages, general disease awareness Pages, and unbranded campaign Pages will have their comments re-enabled for their Walls, photos, and videos.
Jonathan Richman, group director of insights and planning at WPP’s interactive agency arm, Possible Worldwide(www.possibleworldwide.com) notes that “whitelisting” will apply and gives a detailed explanation at his blog, www.doseofdigital.com.
So what happens after August 15? Some pharma companies may ditch Facebook as a channel, but that’s not necessary, says Joe Doyle, interactive director at Austin, TX-based agency HCB Health (www.hcbhealth.com), because the social manager will likely be using a software tool like Radian6 (www.radian6.com), or any of the dozens of competing offerings such as Nielsen’s BuzzMetrics, ThoughtBuzz, Lithium, which scan the Internet with special emphasis on social elements for all mentions of a brand and allow companies moderate, monitor and correct statements that put the company at regulatory risk because with or without DDMAC guidelines or a formal rule, the rules of engagement are “very black and white. We all know what our boundaries are, what we can and can’t say regarding standards such as fair balance and off-label content.”
One of the more recent developments from Radian6 is a partnership with Asentech (http://beta.asentechllc.com), whose new, combined system trolls a claimed 330 million sites every five minutes to offer ratings like other systems, with a difference: The partners have added a staff of physicians and pharmacists to mediate the data for pharma brand manger users before pulling the trigger on weekly or monthly reports.
Even companies who shy away from social media due to regulatory fears should still be aware of what people are saying about them. Monitoring, or as some call it, “listening,” assisting companies in their marketing and overall in pharmacovigilance efforts that can help prevent or mitigate situations that can lead to adverse events, improper off-label use and warning letters—whether or not the FDA ever offers guidance or formal rules.
Existing rules will do
“I think the longer it takes the less likely we are going to see rules from FDA,” says David Ormesher, CEO of Chicago-based agency closerlook (www.closerlook.com). He says the agency “has more to lose” by publishing regulations because “it is balancing a lot of interests, and have gotten a lot of heat over the years for even opening-up direct-to-consumer advertising TV. They’re already getting a lot of heat from people for the amount of promotion that pharma does on the web as it is. So I think they like this tension they have from Pharma right now.”
Eileen O’Brien, director of search and innovation at siren Interactive (www.sireninteractive.com), a Chicago-based agency specializing in rare disorders, says she was “very optimistic two years ago” that DDMAC would issue guidelines, but is not sure they’re needed today: “We’re still waiting for guidance for using the Internet, but that hasn’t stopped anybody from doing a website.” Pharmacos seem to be coping by following existing guidance for TV and print media promotions.
“It’s easy to get distracted by a shiny, new object,” says O’Brien, who stresses that social media aren’t a strategy “but a tactic that has to tie back to larger marketing and brand objectives. It’s not right for every brand.” Companies should first attend to higher-priority interactive tactics such as a creating a compelling, frequently-updated website and search-optimized e-mail campaign that reaches key audiences.
In the face of the evolving if amorphous nature of social networking, statistics aren’t everything; even Manhattan Research, a New York market-research company specializing in tracking new media, is sidestepping some of the frothier parts of the social media buzz. Monique Levy, VP of research, says that the firm routinely finds itself doing “a lot of explanation to contextualize the data” revolving around social media activity and that business models are still evolving. For the time being, she says, the more significant activity is focused on mobile technology at a time when consumer and physician mobile apps are surging and the research firm estimates that 91% of US physicians are using some type of smartphone, and that 75% of all physicians own some form of Apple device, such as an iPhone or iPad. The firm is now conducting a study on physicians’ opinions of sales-rep presentations using digital media.
Web or mobile Web, there’s plenty of opportunity for pharma social networking despite regulatory restrictions, as hundreds —thousands—of online social connections attest. But where to start?
Ben Curtis, a strategist at Cary, NC- based healthcare agency MicroMass Communications, (www.micromass.com), starts with a “pure definition” of social networking as “getting a community of people engaged with one another and having, for our purposes, discussions about the brand. It’s really no different than word-of-mouth marketing just that it’s happening online.” This starting point leads him to help clients facilitate one-on-one communication between two patients, “where all the pharma is doing is connect them so they can speak outside of the pharma network. One way to do this is to partner with associations to build communities, facilitating patient-to-patient or patient-to-doctor communications, as well as a “good relationship between the association and the pharmaceutical company.”
Going forward, social networking may or may not become an easily measured media segment to track. It’s not that market shares and data are top secret, but that it’s difficult to get accurate audience data beyond users and “likes” on publicly accessible sites, or—more importantly—tracking physicians on targeted, registration firewall-protected physician-only sites like Medscape Physician Connect (http://www.medscape.com/connect), Sermo (www.sermo.com) or Ozmosis (www.ozmosis.com), or any of hundreds more health-related venues. User counts don’t measure active users, nor do total user counts for which there’s likely to be plenty of overlap.
“A marketer is better off reaching physicians in a closed community because even if they’re on Facebook, they’re not consuming pharma information there,” says Tim Lewis, director of strategy for interactive and relationship management for Chicago-based healthcare agency AbelsonTaylor. Because every rule seems to have an exception, AblesonTaylor has found one group of healthcare providers using Facebook: 2600 night nurses in hospital nurseries who have special needs and can be overlooked in the nursing world. AblesonTaylor created this presence for Abbott’s Similac brand. Lewis’ associate, Bekah Locker, manager of social marketing, notes that this is “a community space where night nurses could come together, engage in conversation and connect with each other on topics they find relevant.” Abbott doesn’t push the brand, but has provided “an authentic place for that type of engagement.” The moderator shares relevant information for sleep disorder, working with patients and the challenges of working at night.
The content isn’t on the brand so much as the cause—which is exactly what prescription drug marketers say is the easiest way to build audience affinity. Lewis says “the FDA has never issued a warning letter for letting people talk about a brand on any social space. The warning letters have been associated with not providing fair/balance” when a site is controlled by a brand. And on this Facebook site, over the past tens of thousands of posts, only removed two posts have been removed. Says Lewis: “We want authentic conversation. If that authentic language includes criticism of something we posted, so be it.”
The same applies to prescription drugs: “One of the easiest ways for a brand to get involved in terms of the social space is to do cause marketing.” Pharma marketers typically gain access, and then only some, on closed physican sites, depending on their level of sponsorship, and so, Lewis says, “it’s harder to have an ongoing dialog [in a closed community that’s sponsored.” That also goes for custom sites and pages created using platforms by custom developers such as within3 (www.within3.com). But opinions diverge on such topics because the “social” market may never be a market segment that can be as easily measured as more monolithic channels.
Even mobile platforms are easier to measure, despite “huge regulatory issues,” says Manhattan Research’s Levy: “Every screen is different; fair/balance is different; platforms are different—it’s a whole other beast. People are already tackling that within pharma. It’s a bigger priority than social this year.”
Even if social becomes a stepchild to mobile, social media won’t fade into the woodwork so much as become part of the architecture of the Web. “Things are changing so rapidly,” says Genentech’s Musick, “that in 5 to 10 years, it will be increasingly difficult to make the distinction from social as distinct from Internet media. There will be socially enabled features everywhere online, as well as mobile.”
Big (Pharma) Brother?
However, there is already a debate building over online listening, which makes it one of the agenda items of the newly formed Digital Health Coalition (DHC). Founded by Mark Bard (former president of Manhattan Research), DHC brings together many leading pharma companies with Google, Epocrates (an online medium for physicians) Health Central and Digitas Health. The group is seeking to build consensus within the manufacturer community, and interact with FDA and other regulators. Bard says that the debate on behavioral tracking and digital privacy “is a major issue” to all advertisers, not just in healthcare. “There are voices out there that are saying the very premise of behavioral tracking is a bad thing. That has impact on every industry and it can also have a significant impact on the pharmaceutical industry.”
However the privacy/behaviorial tracking/mobile communications discussions play out, one thing seems certain: a year from now there will be yet other new issues bubbling out of the social media mix. PC
BOX: ROCHE'S PRINCIPLES FOR ONLINE ACTIVITY
Codified in late 2010, Roche’s guidelines apply worldwide, and are an example of how pharma companies are grappling with the changes in communications media. The company also has a Social Media Advisory Board to address new issues. The following is excerpted from the company’s website, roche.com.
I. Personal online activities
1. Be conscious about mixing your personal and business lives. There is no separation for others between your personal and your business profiles within social media. You must be aware of that. Roche respects the free speech rights of all our employees, but you must remember that patients, customers and competitors as well as colleagues may have access to the online content you post …
2. You are responsible for your actions. … Anything that brings damage to our business or reputation will ultimately be your responsibility. This does not mean that you should refrain from any activity, but that you should use common sense …
3. Follow the Roche Group Code of Conduct. When “speaking”, be compliant with the Roche Group Code of Conduct, as well as all other Roche Positions, Policies & Guidelines (i.e. Protection of Privacy, Rules on Insider Trading, etc.) …
4. Mind the global audience. Even if you are posting on a “local” platform, the information may be accessed globally. This is particularly important in our regulated business …
5. Be careful if talking about Roche. Only share publicly available information. You are not allowed to talk about the revenue, future plans, or the share price of Roche as this may have serious legal repercussions for you and the company.
6. Be transparent about your affiliation with Roche …
7. Be a “scout” for sentiment and critical issues. … If you come across positive or negative remarks about Roche or its products online that you believe are important, consider sharing them by forwarding them to your local communications department. This is most important in the case of so-called “Adverse Events”...
II. Professional online activities
The following principles outline what to consider when representing Roche as an official online spokesperson:
1. Follow the Roche Group Code of Conduct and Communication Policy. In the core of all communication engagements is our commitment to transparency, balanced information and equal treatment of all parties …
2. Approval processes for publications and communication. … Given the interactivity and speed of the new medium, however, it is not realistic to have each response undergo full approval by communications, legal and regulatory. Therefore, you should establish with your usual approval partners a common agreement on a bandwidth of topics and instances that may not require the normal process. …
3. Mind copyrights and give credit to the owners.
4. Use special care if talking about Roche products or financial data. Communication about the revenue, future plans, or the share price of Roche as well as statements about our products (“promotional information”) is reserved to experts in the field who have been trained to do so …
5. Identify yourself as a representative of Roche.
6. Monitor your relevant social media channels. Make sure you know what is being discussed, so that you can respond when issues arise. Have rules in place to deal with potential Adverse Event reports or potentially inappropriate or illegal content … Also, be mindful of any obligations to preserve data that may be subject to a legal hold.
7. Know and follow record management practices. … Keep records of our interactions in the online social media space. Because online conversations are often fleeting and immediate, it is important for you to keep track of them when you’re officially representing Roche.