For a more in-depth analysis of the Gliadel letter and implications for marketers:

RTCRM Perspectives Video Marketing FDA Warning Letter 6 23 10

The FDA currently oversees prescription drug advertising by reviewing ads submitted by drug companies, investigating industry/consumer complaints about promotional materials, and monitoring pharmaceutical industry events. However, with limited staffing resources, the FDA and DDMAC are unable to analyze and evaluate every prescription drug–related advertisement.

To address this gap in DDMAC’s monitoring abilities, the Bad Ad Program aims to educate HCPs on current DDMAC prescription drug promotion guidelines, teach them how to recognize common pharmaceutical advertising missteps, and provide them with an easy, potentially anonymous, method for reporting possible violations.

Of particular note is the Bad Ad Program’s specific goal of enlisting the help of HCPs in curtailing and reporting potentially inappropriate promotional activities: 1) by sales representatives during office visits; and 2) at promotional presentations during industry-sponsored dinners and speaking engagements. This area of prescription drug advertising has seen increased scrutiny in 2010, with the FDA and DDMAC issuing warning letters (http://tiny.cc/mnotz, http://tiny.cc/hgi1k, http://tiny.cc/5yfgx, etc.) citing both printed sales materials and oral statements made by pharmaceutical executives at industry conferences.

According to a May 11, 2010, FDA press release, the program will consist of three phases. Phase 1 focuses on educating healthcare professionals at select medical conventions, with DDMAC disseminating educational materials through partnerships with a select group of medical societies. In Phases 2 and 3, the FDA will refine the educational materials from Phase 1 and continue to develop outreach partnerships efforts. DDMAC plans to kick off the Bad Ad Program at major medical conferences starting in May 2010.

Implications and Action Items

Pharmaceutical marketers should continue to adhere to DDMAC guidelines when developing all prescription drug advertising regardless of medium or target audience; this includes digital promotions and unbranded websites.

With regard to current in-market promotions, marketers should:

• Ensure all branded or unbranded promotional and sales materials:
  • Are accurate
  • Balance the risk and benefit information
  • Are consistent with the prescribing information approved by the FDA
  • Only include information that is supported by strong clinical studies

• Review all branded or unbranded promotion and sales materials and remedy any of the following:
  • Omission or downplaying of risks
  • Overstatements of effectiveness
  • Promotions of off-label or unapproved uses
  • Misleading drug comparisons

To review the Key Points of FDA Healthcare Professional Outreach (Bad Ad Program), please visit http://tiny.cc/badadprogram. For more reviews on FDA guidelines, please visit http://www.rtcrm.com/whitepapers and http://www.rtcrm.com/blogs. FDA warning letters and FDA guidelines can be found at http://www.fda.gov.

Download important guidelines for marketers to follow when developing pharmaceutical emails: RTCRM Perspectives Novartis Unbranded Websites FDA Warning Letter 5.10.10

RTCRM_Making Your Movie in the Digital Age_ Apr2010 (presentation notes are in the top left corner)

The power point version of this presentation can be found at www.slideshare.net/rtcrm

Every month or so, RTCRM’s Interactive Strategy team regroups to discuss emerging interactive trends, up-and-coming technologies and expanding usages of social media that we’re seeing applied outside of our client industries.

In our most recent caucus, our team noted the rising usage of QR codes in the magazine and publishing world. While QR codes are an innovative way for print publications to offer readers expanded content/discounts/realtime sales, publishers need to ensure that the technology behind this value-add is widely usable and relevant to their consumer base.

In our test we found that the QR codes, of a particularly wide spread fashion magazine, proved a huge technology fail when a commonly used mobile QR code reader app returned the magazine’s submitted codes as “unreadable.”

When implementing emerging technology like QR codes, there’s potentially nothing more deadly then a user trying and trying to access interesting content and have the application, website, etc. continually fail them. For the users, it’s an immediate turn off and can make he/she reluctant to try the experience again. Worst case scenario, it renders portions of your printed content skipped/glossed over by your readership. Not good.

So while these “cool” and “cutting-edge” technologies, like QR codes, may help the struggling print market, it’s important that marketers/publishers/editors/brands think through these potential add-ons and weigh both the pros (expanded content) and cons (usability fails) that come along with these emerging technologies.

Download important guidelines for marketers to follow when developing pharmaceutical emails. RTCRM Perspectives Email Marketing FDA Warning Letter 4.23.10

We reviewed some key milestones in the past year, including the release of FDA warning letters to Pharma brands for non-compliant banners, search and websites. After discussing the new guidelines (released in May 2009) and the implications for how Important Safety Information is handled through creative and copy, we had a lively conversation about Fair Balance:

Theoretically, the words “Fair” and “Balance” imply a 50-50 split – 50% one thing, 50% another thing. In the case of Pharma marketing this relates to a 50-50 split of benefits versus risks. In the last year it has started to mean 50-50 split of risks and benefits, plus equality of creative and obviousness. We’ve found multiple reasons why Fair + Balance rarely = Fair Balance.

The expectation used to be that TV, print and digital would show a risk for every benefit – to be Fair. TV does it through voice-overs, Print does it by flipping the page, and digital used to do it by dropping Important Safety Information at the bottom of the website. But this really wasn’t that Fair. Why should a user have to flip a page or click around to find the risks, but the benefits get to be front and center and easy to find. That doesn’t seem Balanced. So now the FDA is saying we have to make it more Fair and Balanced by incorporating risks and benefits in the same place. Whenever you cite a benefit of a drug, you need to cite a risk – to be Fair and Balanced. The problem is that while the benefits are usually easy to understand (written by marketers), the risk are usually difficult to understand (written by legal and medical/taken from the prescribing information). So, when you combine something that is easy to understand with something difficult to understand, you end up with something not so Balanced. Not to mention not very Fair to the patient. The FDA also expects that risks and benefits will run in parallel and be related. For example, you might have to state something like, “This drug will help you sleep, but it will also keep you awake”. Well the problem with this approach is that these two may not actually be comparable. If the drug has a 90% chance of helping you sleep, but only a 10% chance of keeping you awake, it would not be Fair to compare them to one another. You would have to find something with a 90% chance of occurring to be truly Balanced.

Clearly the nuances of handling Fair Balance are unique to creative execution, drug indication and medium, but what is unclear is exactly how the new guidelines will improve a patient’s ability to Fairly understand the benefits and Balance the risks.

At RTC we love to test new technology by putting it into practice (the daily grind) as much as possible. Our latest attempt was to use Google Wave as a collaboration and planning tool for a new business pitch. Rather than the internal network, Xinet,  or (sigh) email, we wanted to use something that allowed real-time one -to-one AND one-to -many coordination in a single place. We also hoped the plug-ins (charts, drawing boards, and voting buttons) would allow for more emphatic and engaging content that would spark our brains and getting the creativity flowing. In theory, Wave would be the perfect agency tool. In practice, we suffered from the same, if not additional complaints as the rest of the digital scene. You can find a number of complaints online; Here are our top 5 :

5. Logging in is complicated and requires another username, password and account. You might be able to use your g-mail account, but not if you’re invite went to a personal account.
4. People can see you typing. Once you start typing, even if you decide not to post it, people have already seen it. Privacy is limited. And in fact there’s no need to actually post anything, you just have to type and delete. Type and delete….
3. Gadgets are cool, but you have to go find them on your own. They don’t actually exist in Wave.  You have to go online, search for “google gadget for wave” and then add it. You would think there would be a menu in Wave for this…
2. Collaboration without chronology is a mess. You have the ability to respond to old posts, which sounds reasonable, but really hurts sensory input. I personally found receiving responses to old posts to be chaos- Wave doesn’t even alert you to these posts, so your left thinking no one has responded
1. It is sooooooo slow. So slow that we had to wait 3 hours for profile pics to upload. That’s enough time to plan our strategy, approach and start working on tactics.

In the end we saved everything to the network and communicated via email and meetings. Wave didn’t pass our test, though we did have fun comparing our complaints to the rest of the online world.

All three search engines have started showing Twitter results among the search results. This is a profitable move for Twitter and a questionable move for Yahoo, Google and Microsoft. One that could go really right or really wrong. There are also important implications for brands to consider. But probably the most important and interesting point of consideration is this: If the search engines, who have made billions of dollars refining search results based on user needs, think that consumer-generated content “improves” their offering, at what point will branded content even have a say in the consumer experience? At what point will branded content get kicked to the back row? I’d argue that this movement has already begun. Twitter results on Google? Case in point.

Research has repeatedly shown that people trust their friends and family more than any other source. In fact, according to a 2008 AdAge Article, recommendations from family and friends trump all other consumer touchpoints, further proving the impact of word of mouth. It is also known that consumers rely more heavily on a “person like them” than on branded content  (Edelman, 2007). What the search engines have done by adding Twitter posting to their results is amplified this affect. They have taken the person-like-me-affect and made it easier to access, to review and to act on.

if social networking and consumer-generated content grows and begins to supplant real content, at what point does “real” information even matter? If word of mouth is the best form of information and people trust their friends more than anyone else, why bother ever looking at branded content? Wikipedia is a great example of this. Wikipedia, a consumer-generated information site, on average has 72 Million visitors a month. Compare this to Encyclopedia Britannica, traditionally a trusted expert source in information, who has only 3 Million visitors a month. (Quantcast, 12/18/09) This is the point where consumers have said “I  trust other consumers, more than branded content.”  Now this isn’t so bad- Wikipedia is a great place for information - but what about the implications for retail marketers?

If I am a consumer and statistically speaking I am more interested in what Jimbo948 has to say about the Droid phone than Verizon, why would I even look at what Verizon has to say? I’d rather follow up with Jimbo948.

See, consumers are able to say whatever they want about brands and brands have no ability to stop it. Brands can contribute to the conversation, which if done properly can improve brand perception and make them a leader in the space, (e.g. Zappos, WholeFoods). However, if done poorly companies can hurt themselves further, by going off message or trying to be something they are not. If brands ignore the conversation all together (e.g. Motrin), then consumers are left to fire at will, with no brand input. Of course brands have been dealing with the influence of social media for some time now, but this situation used to be limited to dot.coms and the privacy of personal social networking apps. In most cases, brands didn’t even know conversations were happening. But now that consumer-generated brand “messaging” appears among search results, brands not only have less control, they have to know it’s happening.

So what are brands to do? They should embrace social networking. They should get involved in the conversation in an appropriate, non-intrusive manner. They should enable their consumers with content, and then leave the reach and distribution to the masses. Brands can no longer control the dissemination of messaging, and they need to recognize that consumers are now their eyes, ears and mouths. The brands that become most comfortable with this, most quickly, will be successful. The ones that do not…well they are leaving it all up to “people -like -me”.

It’s not a question any longer whether pharma has a need – bordering on moral obligation – to provide value and service through listening and responding via social media. We’ll build a playbook just like we did when we on boarded e-business initiatives 10 years ago. The real question emerging is WHO within the pharma enterprise will own this roll, and HOW will this new ‘Chief Social Media Officer’ relate to other internal partners and their agencies.

So far, numerous leaders are emerging from the pharma organization from legal, regulatory, brand teams and consumer/HCP centers of excellence. Time for a new COE to centralize this role? Maybe.

From one perspective within our advertising agency, this isn’t far from the decision in the 1960’s when agencies carved out ‘brand planner’ role – the one person who would own the market research (listening) and the planning tool box and ensure pull through to execution. This looks and feels like exactly the same need.

To that end, we’re working on a white paper this week with focus on this new COE role, a potential job description, connectivity to key internal and external partners, and some thoughts on the toolbox – stay tuned..