Unlike most other industries, the regulatory atmosphere surrounding a healthcare product or service can be a sword or a shield–virtually any statement about healthcare risks can draw unwanted scrutiny or can benefit from regulatory advantage.

Government regulators are often the forgotten stepchild when marketers are forming their brand strategy, but they can have just as much influence over whether a product is prescribed. That is why it is imperative that marketers find a way to integrate brand marketing with public policy.


Between the Supreme Court upholding the Affordable Care Act and the Senate passing a last-minute fiscal cliff deal that included more than 30 healthcare provisions, 2012 was quite a year for our sector—and rife with challenges for healthcare marketers trying to navigate the implications of these new regulations. But it is because of that very complexity that marketers, now more than ever, must integrate legislative strategy into brand strategy.

Marketers understand the power of messaging—it is the essence of their mission and work. Connecting the right message to the right audience can leverage decision drivers and create an environment that enables sales to thrive. However, in the healthcare industry, one core audience is often neglected by marketers: government regulators. Though they do not prescribe your product, regulators and policymakers exert tremendous influence on the sales environment—and the messages they hear from government affairs contacts should be consistent with the messages projected through marketing channels. By working more closely with colleagues in government/regulatory affairs, marketers can amplify brand messages consistently to all key stakeholder audiences—elevating company reputation and clarity of information for patients, physicians and policymakers alike.

Understanding the Reality of the Healthcare Policy Environment

While the integration of policy and public relations may not be intuitive in most industries, it is imperative in healthcare. The healthcare industry is one of the most highly regulated, and technically complex, industries in the world. The FDA, Medicare and Medicaid statutes are renowned for being dense, lengthy, and complex,1 and are accompanied by continued Congressional oversight on the impact of healthcare products on both the federal benefits programs and public health. Thus, unlike most other industries, the regulatory atmosphere surrounding a healthcare product or service can be a sword or a shield—virtually any statement about healthcare risks can draw unwanted scrutiny or can benefit from regulatory advantage. The key to navigating this environment is integrating marketing—and specifically, public relations—with public policy to ensure that brand marketing becomes an advantage, not an Achilles heel, to a successful product.

Integrating brand marketing with public policy is particularly important given the potency of marketing materials in the policy debate. Congressional staff are overwhelmed with information, and often do not have the time or resources to “dig deep” into an issue brought to their attention by a constituent or the media (including social media). As a result, Wikipedia and Google can often become principal information sources, and brand marketing materials have special prominence as often the principal (and sometimes the only) source of information about a given product. This reality presents a double risk. For those companies who do not have Washington representation, the brand presentation will be the sole message, and both Congressional and federal regulators will use the brand communications as a proxy for the company’s voice. For those companies with Washington representation, conflicting policy and marketing messages risk confusion at best, and mutually negate each other at worst.

Integrating policy and marketing messages not only protects companies against this scenario, it can elevate both endeavors, producing a more powerful marketing message and significantly enhancing policy advocacy if and when it’s needed.

The Importance of Integration

Over the years, we’ve seen that as big pharmaceutical companies become leaner, with individuals taking on more and more responsibilities, there has been less interaction and integration among departments. Yet, it is ever more critical to avoid silos as government continues to play a greater role in healthcare. When we have silos, we tend to see our discipline as the solution to the problem. As the old saying goes, when you have a hammer, everything looks like a nail.
It’s critical for marketing executives to reach out to legislative colleagues to understand how their words and actions could impact company interests on the Hill—and vice versa.
A critical first step to engaging the government regulator audience is by understanding how it consumes information in the first place. A recent study by National Journal entitled “Washington in the Information Age: Inside the Beltway Media Consumption in a Digital World,” offers insight for marketers to consider in enlightening brand strategy:

  1. While the private sector is more likely to be interacting with LinkedIn, Congressional staffers—perhaps as an indication of their younger demographic—are more likely to use social media products like Twitter and Facebook.
  2. Mirroring similar trends nationwide, the iPad has quickly gained traction in the Beltway, with up to 44% of Congressional staffers indicating that they either own or plan to purchase one.
  3. While Android adoption rates nationwide soar, BlackBerry remains the top mobile device on the Hill.
  4. Email newsletters are a prominent and consistent source of information throughout the workday for Congressional staffers. In the morning, they are the top news source and rank second throughout the day after websites on a computer.
  5. Print is still relevant and desirable for Congressional staffers: 62% indicated that they prefer reading longer content in print rather than on a computer. More than half of those between the ages of 31 and 40 felt this way about print, and 42% of people under 30 rely on print for more in-depth content.

When Government Payers Threaten Access

Several years ago, the Center for Medicare and Medicaid Services (CMS) cleared managed care plans to include Kos Pharmaceuticals’ Niaspan (extended-release nicotinic acid) on their Medicare Part D formularies, ensuring that seniors prescribed the product would be able to safely and effectively raise their HDL cholesterol by as much as 26%. Shortly before Part D launched, however, CMS withdrew coverage for Niaspan based on a federal statute prohibiting reimbursement for all “prescription vitamins” except prenatal vitamins—regulators had mistakenly classified Niaspan as a vitamin (niacin). Following this reversal, many Medicare Part D plans dropped Niaspan coverage.

For Kos, the goal was clear: Regain Part D coverage for Niaspan. The strategy was debated hotly as departments each found their own discipline to be the answer. Lawyers thought the right approach would be to sue the federal government. Government affairs colleagues wanted to tell Congress that the decision would cost jobs. Marketers and public relations executives wanted to go to the media. We worked with the company to bring all the departments together and define a strategy that would achieve the goal without being wedded to a single discipline. Our strategy was to apply positive pressure to the CMS Administrator to enable him to realize he had the legal authority to reverse his decision.

To achieve this, we sought allies. We leveraged intra-government disagreement on the definition of “vitamin” and collaborated with government agencies to increase dialogue within CMS. We mobilized third-party advocates (legislative, administrative and medical) around patient safety and efficacy, reminding stakeholders that there is no over-the-counter (OTC) niacin, only supplement and prescription, so removing prescription niacin from formularies would pose risk to seniors whose doctors had specifically prescribed therapeutic-level prescription niacin in accordance with clinical guidelines. We enabled third-party patient and healthcare provider advocacy groups to apply positive pressure on CMS to reverse the decision. They felt the battle was theirs, and provided a groundswell of support for remaining within clinical guidelines. These groups met with Congress, CMS and FDA decision makers to discuss data and to provide the necessary information for the Administrator to realize he had the authority to reverse the decision.
To keep the pressure positive, we avoided media coverage, with the exception of one article in the hometown paper of many of the Administrator’s key staff. Within just a few months, CMS, in consultation with FDA, revised its decision. All Medicare beneficiaries now have access to Niaspan under Part D basic. This happened only because of the integration of marketing and public policy efforts.

Recommended Steps for Brand Marketers

As discussed above, brand marketing in the healthcare industry, perhaps more than any other, requires integrating branding and public policy communications. We recommend the following steps that brand marketers can take to ensure consistency in brand and advocacy messaging:

  • Understand the policy space—is the brand category under investigation or the subject of Congressional (or state) action?
  • Does the brand marketing approach touch on a political sensitivity (e.g., price or the drug’s contribution to the therapeutic category)?
  • Does the marketing message compete with the company’s policy messaging? With the industry messaging?
  • What price is the medication?
  • What percentage of patients will be under government payer plans?
  • How can the brand marketing enhance policy advocacy and vice versa?
  • How can regular communications be established between the two teams?

When coordinated, brand marketing and policy advocacy can each truly enhance the other. Indeed, as demonstrated by the case study above, there are often times in which both are needed for a product to survive. Whether due to crisis, or simply as the ordinary course of business, integrating legislative strategy into brand strategy is becoming mandatory in the healthcare sector. And that is a good thing.

1. Social Security Act Section 1395 and 1396. See also Part 42 Code of Federal Regulations. The statutes alone are hundreds of pages long, with thousands of pages of regulation and tens of thousands of pages of other guidance documents.

  • David Farber, JD

    David Farber is a partner at the law firm of King & Spalding, based in Washington, D.C. David is a health policy expert, representing clients before the Courts, CMS and the Congress on a range of healthcare issues.


You May Also Like

What Does a Microsoft, LinkedIn Deal Have to do With Healthcare Marketing? Everything.

Microsoft is buying LinkedIn. The eye-popping $26 billion headline number aside, does this matter? ...

Measuring the Impact of Telehealth Marketing

In a recent “State of the Point of Care Marketing Industry 2022” report, a ...

Cutting Edge

What’s not to love about the latest technology and the hottest trendy products? Our ...