Bob Sperber

While sampling has been the traditional method of getting patients to try new therapies, the use of coupons or vouchers—often targeted directly to consumers rather than physicians&mdash;are on the increase. In these difficult economic times, such financial incentives are attracting more consumer interest, and the availability of these consumer discounts is being magnified by Web-based promotions in addition to conventional print media. In parallel, coupons and vouchers are demonstrating value in raising or maintaining patient adherence to therapy&mdash;a good thing from most healthcare payers’ perspective&mdash;but are attracting more criticism from them when the incentives are plainly directly at countering higher-co-pay, higher-cost second- or third-tier formulary positions. The contention is that pharma marketers are circumventing the plans’ goals in steering patients to lower-cost drugs. 

, in an article published at the beginning of this year, that use of coupon programs has tripled since 2006. Coupon programs are even figuring in pharma companies’ Wall Street presentations: during J&J’s quarterly conference call in October, CFO Dominic Caruso told analysts that, in order to recover lost market share from its recent product recalls and competition from private-label OTC products, “our marketers are very good at knowing what they need to do to attract consumers [with] a mix of brand marketing and expenses, couponing, innovation, etc.—a surround-sound impact to get consumers back,” according to Bloomberg News. 

Paul Kandle, VP and GM of Opus Health, a division of Cegedim Relationship Management (Bedminster, NJ). Opus was one of the first companies to capitalize on the “secondary adjudication” steps that were put into claims-processing systems at pharmacies, once a copay had to be linked not only with a specific health plan, but also with the identity of the drug being prescribed. Since then, it has run over 1,000 programs for manufacturers, and says that it has 250 programs currently. “These claims-processing systems allow manufacturers to overcome two obstacles to patient assistance: the complexity and difficulty of getting samples into the hands of patients after a prescription has been written, and the ability to provide a refund at the point of sale, rather than taking actions like mailing a coupon and receipt into a fulfillment center.” Vouchers (which figure primarily in getting free samples dispensed) enable the prescription to be filled at the pharmacy—and to be documented in the claims processing system&mdash;as opposed to being handed out by the physician; however, Kandle notes that there is still a perceived value by physicians in being able to hand out a sample directly. 

On the copay side, the original need was to ensure that the pharmacist “would be made whole” financially if a discount on a copay were transacted; the secondary adjudication ensures that that happens. As these details were worked out, the overall economics of running coupon and voucher programs became more positive. 

“Manufacturers always had pressure to reduce costs overall, but the pressure’s much greater today,” says David Merkel, senior vice president of business solutions for J. Knipper and Co. (www.knipper.com), Lakewood, NJ-based multi-channel marketing services firm. “Rightly or wrongly, pharmaceutical companies have been painted as the bad guys…and are being expected to absorb much of the costs.” 

	Free-trial vouchers, started as an alternative sampling vehicle to help contain those costs, says Merkel, “but have led to other components from direct mail to longer-term vehicles to promote patient persistency with other forms of patient co-pay assistance.” 

And yet physician sampling programs are still a starting point for patient outreach, with 85% of manufacturers distributing trial samples directly to physicians through their sales reps or via direct-to-practitioner (DTP), according to a survey report presented in September by TGaS Advisors (www.tgas.com), and the PDMA Alliance (www.pdmaalliance.org) at September’s 

 in San Antonio. Kevin Sharp, director with TGaS, says trial vouchers are “generally utilized to address ‘white space’ concerns and facilities that do not receive physical samples. These particular channels have seen growth as pharmaceutical companies have changed the structure and size of their sales forces.” 

Still, with the downturn in the economy and years of pharmaceutical mergers, prescription drug manufacturers are “looking for ways to do more with less. And because there are fewer reps out there, there’s less sampling going on than in the past,” says John Khantzian, senior principal, LifeLink Solutions, IMS Health (www.imshealth.com), Danbury, CT. “And where that sampling that does still exist, it’s being done based on priorities developed through physician and patient segmentation analyses.” So, for example, if there’s a managed care influence in a certain area, the manufacturer may modify their sampling tactics based on its formulary status. This helps to ensure that the physician will have its drugs on hand in the sample closet to provide until the patient fills an initial prescription. 

While hand-delivered samples still dominate according to the TGaS study, those sampled — primarily drug-makers sample-accountability and PDMA compliance professionals – are also exploring other options at high levels: 90% of respondents use coupons; 76% use vouchers; 24% use a pre-paid card; and 17% offer co-pay assistance. 

The most confusing aspect of analyzing these results is trying to discern the definitions of these vehicles — something that won’t soon be answered. 

“There aren’t any consistent definitions across the board for coupons, vouchers, pre-paid cards and co-pay cards,” Sharp concedes. As a result, the survey listed those promotional options and asked respondents to check which method they used. On on end of the spectrum are one-time free trials; on the other are longer-term co-pay-assist card programs that foster loyalty. Given these parameters, it may be possible to discern what promotional vehicle works best for the drug maker-marketer. 

FIG. 1. Total pills purchased over a six-month observation

IMS studied the success of three kinds of patient card programs for one branded pharma company’s (unnamed) chronic therapy (Fig. 1) for which there were a mix of branded and generic alternatives, with generics representing a significant percentage of market TRx (prescriptions written) volume: 

• A multi-use co-pay card for use with multiple prescription fills per year, with a guaranteed maximum level of co-pay or patient out of pocket expense;

	• A limited-use savings card program that guaranteed lower patient out of pocket costs to a fixed dollar amount and

	• A free-trial voucher program for one free prescription fill. 

The objectives of the three programs were to increase the flow of new-to-brand patients and drive brand loyalty. Patients selected were new to the brand, either newly diagnosed or switched from other medications) The result? Multi-use program patients purchased 61% more pills over a six month observation period, while limited-use savings card program patients purchased 28% more pills than the control group. 

Interestingly, the free-trial voucher program resulted in lower sales than the control program. The drug may have carried unwanted side effects, but such speculation fell outside of the research, says Greg Mastrogiovanni, engagement manager, Commercial Services, IMS Health. He avoids such speculation, offering that this isn’t an uncommon occurrence, and that “a good percentage of patients try the product once because its free but never convert to paid therapy.” Beyond that, he didn’t speculate on why those who tried the free trial didn’t continue on the drug as often as the control group. 

Such studies provide very useful data through the identification number printed on each voucher or card, which upon redemption is run through an anonymized, HIPAA-compliant patient-level database, explains Khantzian, providing data on “patient XYZ123… which tells us they used a coupon, voucher or co-pay card. That’s what allows us to create test groups and control groups to the measure adherence, compliance etc., of patients who get the card versus those who don’t. This way, a pharma company can evaluate the results of two different promotions for effectiveness and ROI.” 

While pharma companies factor in costs, and ROI in promotional vehicles remain confidential to the brand, “The measurements around them — how they’re distributed and the ancillary materials – can be so remarkably, incredibly different,” says Tom Foley, director of business development for RxHope, one of the integrated multi-channel sampling and marketing companies of Triplefin (www.wearetriplefin.com), Cincinnati, OH. He says no “one size fits all” strategy can be applied to define a media mix or ROI; an osteoporosis drug for elderly women won’t use the same mix of tools and media as an erectile dysfunction drug; likewise, how a co-pay card or free trial will work depends on the drug, the patient population and when and how it’s deployed in the lifecycle. 

Ned Finn, VP pharmacy at Inmar Corp. (www.inmar.com, Winston-Salem, NC), notes that coupon programs vary not only by therapeutic area, but also by the healthcare objective. “To drive better patient adherence, it may make sense to provide coupons to reduce copay for patients that have proven adherent to therapy. This can have a huge impact on patient clinical outcomes. If the goal is to cross-promote, there are opportunities to use coupons to promote OTC therapies or foods that address the side effects experienced by patients taking prescription drugs for specific health conditions. For example, an online coupon for moisturizers could be offered to someone searching for information on ways to manage side effects of chemotherapy; an online coupon could be offered for foods that address specific health conditions or lifestyle products such as smoking cessation products.” The company, which handles the equivalent of over $6 billion in coupons annually from a wide variety of consumer-goods companies, prints, distributes and then reimburses for coupons used in print media and online. 

	Opus Health, Knipper, Triplefin, Inmar and companies like PSK&W (www.pskw.com, Bedminster, NJ), Trialcard (www.trialcard.com, Cary, NC), Group DCA (www.groupdca.com, Parsippany, NJ) offer a variety of platforms and programs directed at consumers. Programs have evolved from distributing paper coupons to online, print-on-demand coupons, or loyalty cards that are used at the retail pharmacy to obtain an on-the-spot discount for copays. PSK&W has built out a system that integrates coupon distribution with relationship management tools (the DIVO platform) that it says provides a more complete interaction with patients. Most recently, the company linked up with HealthPrize, which is applying gaming technology to the patient adherence problem (Pharmaceutical Commerce, July/Aug 2010, p. 8) to power up its adherence offering. 

Group DCA, for one, connects with the order-entry and reimbursement systems run by McKesson’s Relay Health unit to effect that on-the-spot discount with minimum workflow issues for pharmacists. Catalina Marketing (www.catalinahealthresources.com) says that it has 18,000 pharmacies, within a network of 50,000 retail outlets overall, through which it can manage copay assistance and adherence programs. (The company also runs CouponNetwork.com, said to be the largest print-on-demand coupon system in the world.)

	Meanwhile, the growth of electronic health record (EHR) and e-prescribing systems at doctors’ offices and pharmacies is creating a new channel for electronic couponing. OptimizeRx Corp. (www.optimizerxcorp.com; Rochester, MI), now about a year old, is hoping to ride the EHR wave by integrating sampling and coupon programs with these e-prescribing systems, and has a partnership with Allscripts (Chicago) to bring pharma manufacturers’ programs into that channel. The company says that it has processed almost 70,000 coupons in the past year. 

Medicare and other government-funded programs are ineligible for coupon programs, but Medicare Part D, and its infamous “doughnut hole” that requires patient payment up to a set level annually, has created an opportunity for patients. In helping to subsidize prescription drug costs by mandating a secondary payer field in the electronic claims process, the theory goes, Part D “gave manufacturers greater ability to offer financial assistance with new immediacy,” says Rick Randell, president of Triplefin’s National Patient Services (NPS). Because in contrast to old-fashioned snail-mail vouchers and the like, “the immediacy of on-the-spot secondary payer discounts at the pharmacy, and access to current multi-channel technology services, gave manufacturers the ability to finally make offers they needed to offset the expenses of being a non-formulary product, right at the point of sale.” While vouchers, coupons, co-pay cards and the like were already gaining popularity, the secondary payer field could be used not just for Medicare but for all transactions (Fig. 2). 

It’s part of a tech explosion, he contends, that has brands more interested in tying and tracking promotional activities to Internet and mobile communication technologies. With consumer electronics and the Web now mainstream communication channels, and with patients actively managing their own Health Savings Accounts, more patients are taking to the Web where, says Randell: “A coupon isn’t just a coupon anymore. It’s an opportunity to communicate and work with the patient.” 

Likewise, a website isn’t a website anymore. Beyond static display of information or perhaps printable coupons, brand sites can serving much of the informational role today as family doctors and neighborhood pharmacists did in days of yore. For example, Eli Lilly and Co.’s site for Effient (http://www.effient.com), for instance, offers a plain-English Esstential Habits program to help patients with stents adjust their diets and lifestyles in addition to offering a card that covers the portion of a patient’s co-pay over $25 up to a maximum of $20 each for the next 11 refills. 

And Bristol-Myers Squibb’s website for Abilify (www.abilify.com), a treatment for depression, bipolar disorder and schizophrenia, guides visitors to identify the disorder for which they’re interested, state their informational needs as a patient, caregiver or information-seeker, and invites them to join its “ABILIFYAssist”  (www.abilifyassistprogram.com) program for a free trial and “continued savings” with promotions for the healthcare provider, pharmacist, insured patient and uninsured patient (Fig. 3). Also, there’s a cost-and-coverage calculator, refill reminders and prior authorization assistance where the brand collaborates to help complete documentation and facilitate authorization. 

“You can go on any brand’s website today and there will likely be a link to some sort of card program,” says IMS’ Mastrogiovanni, adding the prevalence of “relationship management programs” of the type illustrated above, where, beyond financial promotions, “there are patient education fulfillment materials and ongoing contact or touch-points via phone, e-mail, direct mail, et cetera — and we definitely see an increased trend in the industry toward these programs.” 

In fact, any Internet, communication or media channel can be part of the mix, from TV commercial “ask your doctor” prompts and website “click here to print-out our coupon” features to opt-in email and text messaging elements, even mobile apps, which are emerging. (In September, Triplefin launched a new Innovations Mobile business to fill that need.) For some, this will beat the frustration calling a plan’s phone tree, although even that’s changing as new-generation IVR (interactive voice response) systems offer 24/7 services offering assistance with similar granularity to websites. 

Given all these content-rich and personally tailored services, patients are much more likely to consider a brand’s value beyond the co-pay to build loyalty, or in the case of free trials, increase the value of the offer due to the trust the marketer builds using all of these technology-assisted services. 

	It’s hard to manage a prescription drug promotional campaign when success when putting the brakes on a promotion can be as important as being proactive to patients’ needs. Viewed from one angle, that’s what happens when a pharma company offers too heavy a discount without offering also-deep discounts to the plans that would rather sell generics. But this is a simplistic view of a much more complicated set of considerations that make promoting prescription drugs a complicated affair. 

Before the drug-maker can promote its drug, it has to establish its a preferred position in a drug plan by offering a sufficiently large rebate — in plain talk, discount – to pharmacy benefit managers (PBMs). PBMs administer prescription drug plans for patients through the group health plans to which they subscribe through self-funded employer or labor union plans, health insurance plans, and Medicare Part D. 

Those rebates act as a discount that’s factored into the formulary process to offset the cost of the drug, and they go “directly to the ultimate payer, such as the employer group, to offset their plan cost,” says Brent Eberle, VP of clinical services for Navitus Health Solutions (www.navitus.com), a PBM based in Madison, WI. 

Once a manufacturer secures pricing and a preferred (or any) position, it then can turn to promotions such as patient co-pay assistance programs. Unlike samples and free-trial offers that don’t incur costs to anyone but the manufacturer, co-pay discounts are generally disliked by PBMs. The reason simple: A more expensive Tier 3 drug can appear to the patient to cost the same as a preferred Tier 2 drug when in fact its cost to the plan is almost always higher. Eberle says situations like this — aggressive marketing that crosses the formulary line – is “something we factor that into formulary decision making.

“If we feel a manufacturer’s marketing practices are too aggressive, that’s a manufacturer we typically going to be manufacturers we won’t partner with for that drug,” says Eberle. “There have been situations where we’ve been unhappy with a product’s marketing, and that has resulted in putting it in a non-preferred position with fairly aggressive ‘prior auth’ restrictions — even while we have other products of theirs that are in preferred positions.” 

Integrating coupon/voucher/adherence programs with electronic medical records (EMR) systems will be the next frontier for these programs, says Opus Health’s Kandle. 

Currently, a contest is being waged between the EMR vendors and the patient-assistance providers over the cost of allowing a presence in the EMR network. At the same time, the EMR vendors are competing for share of mind with physicians and healthcare networks, so there’s going to be some equilibrium to be reached between the cost of having a presence in the network and the value to the EMR vendor for customer acceptance. PC

Articles

Pharma marketers become adept at refining coupon and voucher programs, while technology options multiply. Meanwhile payer criticism mounts

With coupons, pharma is saying 'Let's make a deal' to consumers

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&mdash;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. 

	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&mdash;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. 

	“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 (

), 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&mdash;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.” 

	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.

	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”...

	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. 

Following FDA’s punt of regulations for social media, industry is scratching its collective head over how to utilize these channels