Companies in all industries face an ever-growing and increasingly complex web of regulations that extend into every business function, including marketing, advertising and promotion. In the United States, there are thousands of both federal and state statutes governing their actions. Inadvertently breaking the law is no excuse, and willfully ignoring it can bring the wrath of the government and the courts down on your head. But pharma and medical device companies are even more heavily regulated, and their marketing practices have been intensely scrutinized in recent years.

Since 2003, pharmaceutical manufacturers have paid more than $7.7 billion in off-label drug use penalties alone. One company paid fines of $600 million after pleading guilty to a misdemeanor for aggressively promoting off-label uses for one of its drugs and financially rewarding top users of the products. Physicians received payment under the guise of serving on advisory boards but, instead, were paid for listening to company presentations given in resort settings. Another manufacturer settled a similar suit for $81 million in 2010 and pleaded guilty to a misdemeanor charge of misbranding a drug after paying physicians to recommend 27 off-label uses for one of its anti-seizure drugs. A third company was ordered to pay a record $1.2 billion in criminal penalties, plus another $1 billion in civil penalties for continuing to promote off-label use of several drugs after being told by the FDA to stop the practice. The company was also found guilty of giving kickback payments to doctors in the sale of nine other drugs, among other practices.

Now two new marketing-related sets of regulations are making their debut. The first is a set of FDA-issued guidelines for social media and other online marketing channels. Called “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” these guidelines would allow comprehensive answers to unsolicited questions about off-label drug use through private communications with individuals, but would not allow detailed discussions on social media like Twitter or Facebook. Instead, pharma companies would be required to tell inquiring individuals to contact them directly for more information. Additionally, the answers they provide would have to be non-promotional in nature and come from someone other than a sales or marketing employee.

The second new piece of legislation is the Physician Payments Sunshine Act. This law requires drug and medical device manufacturers and suppliers to report any “payments or transfer of value” to doctors and teaching hospitals of $10 or more, as well as aggregate payments of $100 or more in a given year. While product samples and educational materials are exempted, virtually everything else — from lunches and coffee mugs to travel, entertainment, speakers’ and consultancy fees — is covered. Unknowingly failing to report covered payments carries penalties ranging from $1,000 to $10,000 per unreported transaction, with a maximum of $150,000 per year. Knowingly failing to report can get you fined $10,000 to $100,000 per incident, up to $1 million per year.

Because marketers often outsource key functions like fulfillment, they need to make sure their business partners are up to speed on regulatory compliance, as well as policing their own internal policies and procedures. At minimum, you should be looking for a fulfillment vendor who offers:

• The ability to capture, index, securely store, archive, and retrieve all versions of both paper and electronic documents (including email and instant messaging).

• An online ordering system that controls user access and ordering privileges and ensures that all required disclosures and addenda accompany any marketing materials ordered

• Reports and auditing tools to track and manage inventory and records management programs (and, in light of the Physician Payments Sunshine Act, the value of all items shipped, as well as cumulative records of shipments to any particular site or individual)

• Timely on-site or off-site destruction that protects confidential information by using modern shredding equipment, highly secure processes and certification of destruction to create a legal audit trail.

As the old saying goes, “an ounce of prevention is worth a pound of cure.” That’s advice pharma marketers can take to the bank.

Iron Mountain will demo some of its Intelligent Fulfillment^TM solutions for pharmaceutical and biomedical manufacturers at INTERPHEX 2012, May 1-3, in New York City. Register as our guest and receive free exhibit hall admission and 15% off conference passes.

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Software may seem like the all-encompassing solution your company is looking for to make your marketing easier and more nimble. But, if you’re among those considering the purchase of marketing automation software, you may save yourself some money and quite a bit of frustration by talking to your fulfillment vendor first. Why?

• First, because your fulfillment vendor may have capabilities that duplicate or at least augment those of popular software solutions.
• Second, because you want to make sure that any software you purchase will integrate seamlessly with your fulfillment programs.
• Third, you want to be ready with the right communication strategies and collateral when your automation program goes live.

The right fulfillment partner can help in all three of these areas, in addition to delivering the fast, accurate lead fulfillment you need to make any marketing program – automated or not  –  a success.

You can read more about each of these issues in my article titled “3 Keys to Fulfilling Automated Marketing,” which was just published in the Today@TargetMarketing newsletter.

Your thoughts and comments are welcome! Join the discussion below.
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Marketing being the complex endeavor it is, you’ll need to talk not just to your peers and staff, but also your immediate superior and, possibly, the executives in the C suite. While you may be focusing on the number of campaigns you want to launch, the response rates you’re anticipating and the leads you’re hoping to generate (something that usually resonates with sales), you may find your CFO is concerned about the costs to generate those leads, while the CEO is asking about ROI. If your marketing also includes public relations, your PR people may be looking at column inches or the number of bylined articles they get published.

It’s your job, as the CMO, to pull all of these disparate hopes, dreams, wants and wishes into some kind of unified plan for the year, complete with measures for success. (As if you didn’t already have enough to worry about!)

While you’re at it, don’t forget that at least a portion of your ability to successfully implement all of your plans depends on the performance of your vendors. You may think of your fulfillment partner as the company that pushes things out the door after the fact, but fulfillment can be a useful resource during the planning phase. Your account team can work with you to analyze how well your previous and current communications, media and underlying production processes are working and suggest ways to increase efficiency and enhance results.

Often, the same technology or tool can achieve both of those ends. Data-driven, variable digital printing is a good example. Using this technology, you can personalize your materials for greater relevance – and do it cost-effectively for a market of as little as one person – because digital print eliminates expensive, time-consuming make-ready and press preparation. Because digital print allows you to print just in time, it also lets you eliminate storage, insurance (and, ultimately, disposal of) large quantities of inventory, for further cost savings.

You can also use digital print to produce other materials on an as-needed basis – perhaps when offset inventory reaches a certain quantity, or for materials needed only during certain periods of the year, or for items that change frequently, such as price lists. Your fulfillment partner can help you identify which materials are good candidates for this type of production.

The point is – your fulfillment partner has a lot more to offer than just pick-and-pack. Getting your account team involved whenever you’re in planning or reevaluation mode can help put you on the road to greater success in the months to come.

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At some point in our lives, we’ve all asked ourselves whether we would rather be big fish in a little pond, or little fish in a big pond. It may have come up when considering what college to attend or which company to work for.

As it turns out, individuals aren’t the only ones to ask themselves this question. During a conversation I had with a new client the other day, he mentioned that the big fish/little fish dynamic had been a concern for his company when deciding on a new marketing production and fulfillment partner.

The advantages to swimming in a big pond, this company reasoned, include financial stability and longevity, as well as a larger array of resources. One point of access to tools like digital and variable data printing, custom kitting, electronic delivery and design on demand capabilities, in turn, make it easier to plan and execute integrated, multi-touch, multi-channel marketing campaigns. On the other hand, a smaller fulfillment company might be more responsive, give them a higher degree of individual attention and offer more customized solutions.

Happily, as this client learned, we’re able to deliver the advantages of both. We started out more than 40 years ago with an operating philosophy of personal service and accountability, with dedicated account teams and employee compensation and advancement based, in large part, on helping clients meet their goals. We made strategic investments in technology to advance the state of the art in marketing production and fulfillment, based on customers’ expressed needs, as well as market trends. And we set up production and warehouse facilities in key locations across the nation, to provide fast, localized service at the lowest possible cost.

At the same time, as part of Iron Mountain, we offer unequaled financial stability, scalability and global reach. We’re able to draw on the innovative resources of this world leader in document management and compliance to provide a comprehensive array of tools and services for marketers of every size, in any industry or geographic locale.

In short, whether you’re a “big fish” or a “small fish,” we’ll give you the same individualized attention and work with you as though we were members of your own staff. So swim on over to our pond — the water’s fine!

• Identifying Your Needs to the Right Fulfillment Partner
• B2B Sales Lead Generation: Achieve Balance Between Online and Offline
• Special Report: Solve Document Retention Dilemmas with Integrated Digital Archiving
• Webcast: Mastering Your Distributed Marketing Challenges

Consider direct mail, for instance.  Target Marketing Magazine’s Media Usage Forecast 2011 found that direct mail is the marketing medium with the highest ROI for both client retention, and the acquisition of new clients.  Surprised? 

Assuming the research was skewed to older clients?  Think again.  According to a 2010 study from ICOM, a division of Epsilon Targeting, “North American consumers in the valued 18-34 year-old demographic prefer by a wide margin to learn about marketing offers via postal mail and newspapers rather than online sources such as social media platforms.  Additionally, the ICOM research shows that preferential attitudes about the trustworthiness of mail strengthened for consumer respondents in all age groups from 2008 to 2010.”

Why the preference for offline marketing?  One major reason could be the high percentage of email spam messages we’re constantly subjected to.  The June 2011 Symantec Intelligence Report found that spam accounts for nearly 73 percent of all email – and that number is actually down from recent years – Symantec said spam was at its lowest level since November 2008.  It sure didn’t feel that way wading through the junk in my inbox every day.

Do spending trends reflect this offline marketing preference?  Advertising and marketing consultancy Winterberry Group’s “Outlook 2011: What to Expect in Direct & Digital Marketing” projected a 5.8% increase in spending on direct mail in 2011, to $47 billion dollars, after a decrease the previous year.  By comparison, direct and digital ad spending will increase by only a slightly higher percentage (6.2%) to $163.9 billion. 

In an interview with Direct Marketing News, Bruce Biegel, Winterberry Group’s managing director said, “Direct mail is seeing an increase because while acquisition in the online market is improving, it is not yet as effective for local marketing, trade area marketing, or targeting at scale.  Therefore, because [direct mail] still works for many verticals, money is flowing back, because it’s controllable and measurable.”

No matter how you deliver your messages, they should focus on solutions rather than raw product data or features alone.  Remember to offer content prospects can really use; the content must be relevant to the recipient.  Along with systematically moving prospects one step closer to the point of purchase, your strategy should center on building confidence in your company and its products.

Curious about how to apply these ideas in the BtoB space?  Iron Mountain Fulfillment services will be at #DMA2011, October 1-6 in Boston.  If you’re coming to the exhibit hall, stop by booth 321, ask for me and say hello.

Related Links

• Webcast: Mastering Your Distributed Marketing Challenges
• Event: DMA 2011 – The Global Event for Real-Time Marketers