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.

Newell Rubbermaid: Social Media from a Multi-Brand Perspective, by Bert DuMars; presented by GasPedal and the SMBC from GasPedal on Vimeo.

Key things to really hear:

• The importance of understanding the culture of Twitter, Facebook or other platforms
• Don’t start with the technology.  Facebook might not be right for your goals.
• You have to immerse yourself, not just publish.
• Don’t just talk about business, have fun.
• It’s an eco-system – how does social media fit with your entire PR & Marketing plan?
• Scale it! Test and Learn
• Monetize when the time or place is right

Cross Posted on www.carlenlea.com

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..

1. There are numerous definitions of RM that generally aim at achieving business results through ongoing dialogue and mutual value exchange. What matters, though, is “how you trust” – and this depends on your vantage point and the value you perceive. While RM depends on the building of mutual value through a planned series of marketing interactions, the majority of tactics discussed still remain within the realm of “direct.”

Direct marketing is an initial outbound marketing activity that seeks to capture customer data, deliver a choreographed communications stream, and drive a conversion or retention objective. But it has proved hard for pharma to generate cycle times fast enough to truly provide a second or third follow-up marketing contact of increasing and customized value. Are we showing the customer we know them? Not as much. In other words, marketers are in the operating mode of short-term direct pilots that seek to maximize reach and frequency with plenty of “acceptable” spillover.

I believe the jury is still out on whether outbound direct marketing goes far enough in showing we have heard the customer, and likewise have earned greater trust points through ongoing dialogue.

2. Furthermore, on the subject of short-term marketing, the conference group discussed how larger-portfolio companies are known for fast rotations of key marketing managers (1.3 years’ tenure on average). How does this impact a team or organization’s true commitment to long-term community relationship building? Short-term marketers, held to short-term results, are compelled to expect an immediate return. So what are the implications for staying “direct” and not closing the relationship loop? These marketers might overlook investments in relationships for the longer term. Smaller, more condition-specific companies (Novo Nordisk and diabetes, UCB and epilepsy, to name two) seem to have a better alignment, with a top-down mission to truly partner with the specific disease community for the long term – therefore, their corporate and brand reputation-building activities, even social networking, take on a special passion – as everyone in the organization becomes intensely passionate about their condition holders.

While the link of protecting authentic community building and sales/marketing is a tenuous line, the truly passionate teams that bring real patients closer in to the process seem to have a better chance at finding that trust and not overlooking long-term category development activities.

3. For big and little pharma to truly place the customer at the center of their planning process, healthy pipelines, including franchises with multiple medicines in the same category, can help strengthen the commitment to communities of condition holders, and nurture the passion, empathy, and trust that are required for true relationship building with condition holders. This will require brand teams to look up, look beyond, and see how their particular brand fits within their own pipelines and line extension life-cycle strategies. A broad view of brand architecture modeling is a new key step that shouldn’t be overlooked going forward.

It’s the duty of all RM planners to help their clients see the forest and the trees – and build in the right marketing process steps for both category and brand development. After all, isn’t this just code for elevating an own-able brand attribute and investing in it, and defending a unique, differentiated positioning? Now that the social media playbook is maturing and gaining adoption, greater alignment is essential to achieving the next level in patient value creation.

These are exciting times, and looking up and around frequently will be key as our health landscape changes over the next few years. If pharma wants to aim at new measurements (like “trust” or health outcomes), looking beyond short-term revenue and ROI maximization is essential for finding new value propositions that will keep R&D manufacturers relevant within the changing health system landscape.

• How to develop and manage FDA-compliant pharmaceutical SEO and SEM efforts
• What Goodle should do to facilitate a better patient search experience
• How to use rich media to maximize digital pharmaceutical campaigns

You can download it for free at RTCRM’s whitepapers site, and while you’re there check out some additional RTCRM thinking.

Email is an incredibly cost-effective, green, response-generating medium, and by implementing best practices , marketers are now delivering real value to their customers via email.  But now i think we need to figure out how to turn all that requested spam into requested content.

To address this challenge, marketers need to focus on where to be flexible, and where to be rigid.  Being flexible in allowing us to opt-in to a frequency that suits them , and allow us easy re-setting of this counter.  Being rigid in sending us content that is deeply relevant – at a reasonable frequency, or, saying "NO" to "spray and pray" when sending us messages, in the hope that a small % of us will respond or buy.

Given the economics of email marketing, paying us this attention and showing restraint in blasting emails will require further discipline and a possible re-thinking of what constitutes"success" when organizing an email marketing plan.  It’s in the marketers interest to do so…

…after all, we’re not really reading our requested spam.

I had originally intended today’s posting on consumer privacy issues to be the second of a three part series. But after last week’s discourse , response from the public was immediate and massive. “We can’t possibly wait two entire weeks to hear about HIPAA or the Final Word on RTCRM’s baseline approach to managing PHI!” they shrieked, frantically wagging their thin claw-like fingers at me. “Post both remaining chapters next week — or else,” they threatened.

“Or else what?” I asked, wishing quietly for the millionth time that I’d gone to librarian school.

“Just finish the post, pretty boy. Don’t make us hurt you,” they said.

“Okay, okay,” I acquiesced. “I’ll finish it up next week. Jeez, Mom.”

Thanks for reading.

ZR

Fair Information Practice Principles

Fair Information Practice Principles are a widely accepted set of guidelines for how companies should collect, store and use personal information collected from individuals. Though technology-agnostic, the ideas behind the principles are fundamental components of relationship marketing ethics, and are as applicable today as they were 30 years ago.

They are:

Notice/Awareness : Data collectors must disclose the intended use of collected data in a clear and forthright manner.

Choice/Consent : Consumers must be given options with respect to whether and how information collected from them may be used for purposes beyond those for which the information was provided.

Access/Participation : Consumers should be able to view and contest the accuracy and completeness of data collected about them.

Integrity/Security: Data collectors must take reasonable steps to assure that information collected from consumers is accurate and secure.

Onward Transfer: Basically requires organizations to apply the Notice and Choice principles before sharing collected data with additional organizations.

Enforcement : A set of rules is only as good as the ability to enforce them. This principle therefore provides for two important stipulations. First, that entities processing personal data be subject to independent oversight. Second, that individuals have a right to legal redress should entities in possession of their data fail to adhere to the law with regard to its use.

Enforcement is where the gap is bridged between ethical principles and tangible law – where specific federal and state privacy statutes come to bear – most notably the Health Insurance Portability and Accountability Act, the federal statute better known as HIPAA.

What Is HIPAA?

Title II of the Health Insurance Portability and Accountability Act provides national standards to protect individuals’ medical records and other personal health information. Among other things, its objectives are to give patients more control over their health information and the ability to set boundaries on the use and release of their personal health records. More specifically, HIPAA requires covered entities to receive written authorization from an individual prior to using or disclosing their PHI to a third party for any reason other than those functions essential to providing quality health care.

Not surprisingly, marketing – defined broadly in the statute as “a communication about a product or service that encourages recipients of the communication to purchase or use the product or service” – is not considered essential to the provision of quality of health care. Covered entities are therefore prohibited from sharing or selling individual PHI to any organization for the purposes of selling a product or service without that individual’s written permission.

Who Is Covered?

Entities considered covered by HIPAA, and therefore subject to its privacy and data treatment guidelines, include health care providers, health plans and HMOs. Individuals themselves are free to share their own PHI with whomever they choose, including market research firms, CPG manufacturers, pharmaceutical companies and any number of other entities not covered under HIPAA. Assuming that their data collection and usage practices are in accordance with Fair Information Practice Principles , these entities are free to make full use of individual PHI even without the express, written consent of the individual. Once an individual voluntarily provides his/her PHI, the federal statute ceases to apply.

What Does HIPAA Mean to Marketers?

This is one of the most commonly misunderstood aspects of the law. For non-covered entities, HIPAA does not place specific restrictions on acceptable use of PHI assuming that the information was collected and obtained in a legally compliant manner. There are other important considerations, however, with regard to use of individual PHI:

1. When acquisition names are purchased from third-party sources (e.g., iCOM ), the owner of the data generally limits the number of times mailers may contact list members – excepting cases in which the targeted individual opts in to additional communications from the mailer. In other words, the limiting factor in how many times a consumer can be mailed to in these cases is not any government stipulation, but the data rental agreement between the mailer and list owner.

2. Marketers must consider the consumer experience . Ultimately, PHI is only available from covered entities (who are forbidden from sharing it) or the individual. A positive and mutually beneficial relationship with a consumer cannot exist if the consumer feels unfairly manipulated or, in the extreme, illegally violated. For this reason, it is always a good idea to gain a consumer’s trust and acceptance of a marketing relationship before setting forth without them.

3. Competitive advantage . When health care providers and HMOs partner with pharmaceutical companies, they can become subject to aspects of HIPAA governing the behavior of business associates. Penalties for the non-compliance of a business associate can be steep, therefore these covered entities are going to be much more amenable to partnership with organizations they know to be conservative in their treatment of PHI.

4. A fourth and often frustrating consideration is that HIPAA itself is only the minimum standard set by the federal government; it is the floor, not the ceiling. Individual states can and do impose additional restrictions that govern the way entities can leverage the PHI of their residents.

What Is the Impact of Individual State Laws?

It depends. A number of states, including California, Florida, Maine, Minnesota, South Carolina, Vermont, West Virginia and the District of Columbia have enacted laws affecting pharmaceutical marketing. They impact everything from allowable gifts to physicians to limitations on the mining of pharmacy data.

The Texas Medical Privacy Act expands upon HIPAA’s definition of a covered entity to include, among others, pharmaceutical companies. This prohibits companies from sharing or using individual PHI for any reason other than that given when the information was collected without first obtaining a consumer’s signature. This does not necessarily preclude marketers from using PHI to market a product to an individual as long as the Notice doctrine was appropriately applied.

The state of California requires pharmaceutical companies to comply with The Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines when marketing to consumers. PhRMA is an organization comprised of the country’s leading drug researchers and manufacturers, so its point of view on the subject of DTC marketing is decidedly fair. It begins with an underlying belief that DTC marketing can benefit public health by educating patients and fostering collaboration with the medical community. A selection of PhRMA DTC principles are summarized here at a high level.

> DTC claims must be accurate and clear, supported by evidence, and compliant with FDA regulations.

> DTC advertising should foster communication between patients and health care providers. Providers should be educated about new treatments prior to launch of DTC advertising.

> DTC advertising should be clear about alternative treatments (e.g., diet, exercise) and risks of therapy.

> Companies should submit DTC television advertisements to the FDA prior to broadcast. The PhRMA guidelines here are actually more strongly worded than the FDA rule itself.

The Final Word

Ultimately, we are obligated to act in accordance with our client partners’ legal interpretations and applications of privacy law. Some clients may choose, for example, to always behave as a HIPAA-covered entity in certain states, while others may take a more liberal (and literal) stance. It is important that we not only understand and document our clients’ policies related to PHI; we must also ensure their policies are applied accurately and consistently across their business.

Apart from individual client directives, however, it is imperative to establish our own organizational baseline position on how we collect, store and use sensitive consumer data. It is a standard that must be universally applied across internal business units as well as to external partners and data providers. Our point of view in this area must be coherent, consistent and based on consumer marketing best practices.

Specifically, our agency’s policy is to consider Fair Information Practice Principles and PhRMA DTC advertising guidelines as the minimum required of new programs that incorporate the collection and use of sensitive consumer data – the starting points from which to build marketing strategies that benefit our clients and their customers while further establishing RTCRM as a leader in the business of Relationship Marketing.

Data is the lifeblood of relationship marketing and we live and breathe it. Industry studies and sales numbers are starting points, but a more profound understanding of consumer behavior requires insight at a more granular level. So we assimilate, study and mine data provided to us by our clients to inform how we segment, target and position marketing communications. And when existing data about our clients’ customers is not enough, we go directly to the customers themselves through the administration of surveys and the integration of transactional data. We build upon and enhance our data – constantly seeking better means of nurturing the delicate relationship between a brand and its customers.

Use and possession of this type of data brings with it a solemn responsibility to protect individuals’ privacy, and nowhere are these issues more important than in the pharmaceutical industry. Customer data related to health is not only inherently more private, it is also protected by a host of industry ethical guidelines and legal statutes.

Th is post summarizes our agency’s fundamental approach to the management of privacy issues as they relate to the marketing of products and services using individuals’ Protected Health Information. Adherence to these principles and a contextual understanding of where they come from will ensure that we remain consistent with the highest legal, ethical and relationship marketing standards.

This post is part one of three; it covers the basics. Subsequent postings will expand upon additional industry guidelines, important legal statutes (e.g., HIPAA) and other key considerations.

Privacy and Security: The Least You Need to Know

It is imperative that every tactic we recommend to our clients is:

> Compliant with all applicable state and federal statutes

> Amenable to our clients and their legal counsel

> Conducive to a positive consumer experience and, ultimately, profit for our client

These objectives should form the foundation of every new campaign we develop, but are especially important within the pharmaceutical vertical. Drug manufacturers have received increased scrutiny in recent years, so it is critical that we in the industry maintain the highest standards when it comes to protecting consumer privacy. Failing to do so not only exposes our clients and us to the risks of negative publicity and costly litigation, it compromises the very thing we stake our reputation upon: the ability to build a symbiotic relationship with today’s consumer.

The golden rules when collecting consumer data to market a product where privacy may be a concern are to: a) tell consumers exactly what we are doing with their information, b) strictly adhere to those stated limits. Our policy must be to remain beyond reproach with regard to the methodologies we develop to collect, store and use consumer data.

Several notable industry organizations have set forth recommended practices when dealing with PHI for marketing purposes, including The Direct Marketing Association (DMA), the American Medical Association (AMA) and The Pharmaceutical Research and Manufacturers of America (PhRMA ). Each is in agreement that marketing organizations must adhere to certain universal policy guidelines.

For most of our clients, this is not a major issue. We work with database vendors or internal database groups that handle the day-to-day management of consumer data. However, there are instances where we possess sensitive customer data and therefore must be vigilant in its treatment. The technical details of how to move, store and encrypt sensitive data are beyond the scope of this document. In general, however, the following rules should be followed when handling this type of data:

1 Do not store sensitive data on an enterprise shared server.
2 Do not store sensitive data on your personal computer.
3 If data must be stored, protect it with a password and strong encryption. (Marketing Intelligence or IT can assist with this if needed.)
4 Do not email sensitive data! Use a secured FTP site to upload and download encrypted files.

Guideline 3: Collect only PHI for which a clear and genuine benefit to the consumer exists

In general, no customer data should be collected unless there is a clearly articulated plan for its use. In the case of sensitive information, it is especially important that consumers perceive an equitable return in exchange for providing their personal information. For example, asking about an individual’s health is acceptable if we then leverage the information to serve more relevant information to them. It is not acceptable to simply store it with no plan for its use.

Guideline 4: Comply with Fair Information Practice Principles

Beginning in the early 1970s, government agencies in the United States, Canada and Europe began to take notice of the how, why and by whom consumer information was being gathered. Their collective goal was to ensure that “information practices” were fair and provided for adequate personal privacy protection. The results of these efforts have been a myriad of reports and codified guidelines through the years. As technology continues to push world economies to an ever-increasing need for better information, it is certain that these rules – collectively known as Fair Information Practice Principles – will only grow in importance.

The universal elements of the principles are widely disseminated, and will be summarized here next week .

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