Xpectives News


Unlocking Patient Engagement: The FDA Wants You to Know This

March 12, 2024 by Oliver Portmann0
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Career highs and lows sometimes feel random: We often call a success “lucky” and a setback “unfortunate.” In biopharma, we may think of a drug launch that turns out to be a blockbuster as such a lucky break. But possible setbacks lurk all along the drug life cycle: The molecule might not meet its endpoints, or we might hit a snag with approvals or with payer formularies, or the market might be much tougher to penetrate than anticipated. Our minds don’t need to wander all the way to the spectacular ethical and legal failures of the Sacklers, Shkrelis, and Holmeses of the world to understand that, in our industry, you can find boom as well as bust.

However, here’s the truth: Even if you can’t control your successes and setbacks completely, they’re not entirely random either. Our careers have higher peaks and flatter valleys if we pay attention to certain seemingly minor details that could blow up to become major problems. The fear of becoming the next Purdue or the next Turing can sometimes cause some degree of paralysis. But it would be foolish to try and solve business problems by refraining from doing business. More often than not, it’s the omission of regulatory and ethical precautions, rather than the actual conduct of marketing, that’s the problem.

Working with the Consumer

Take patient engagement, for example. It’s a crucial part of any medical marketing plan, and not only because the other strategies are becoming harder to execute—we all know that pharma reps have a harder time getting in front of doctors. But more profoundly, the empowerment of patients in their healthcare decisions has revolutionized the way pharmaceutical companies approach the market. It’s not just about keeping pace with industry trends, it’s about leading the charge in a healthcare environment that increasingly values personalized care. In today’s digital age, patients have access to a wealth of information and a voice through social media platforms, patient forums, and advocacy groups. They are well-informed advocates for their health, often arriving at the doctor’s office armed with research and questions about their treatment options. This shift requires pharma marketers to engage in two-way conversations, where listening becomes as crucial as informing. In this environment, the role of the marketer evolves to that of an educator and facilitator, providing the tools and information necessary for patients to make informed decisions about their care. If you’re a pharma marketer in 2024, whatever you do, don’t ignore the consumer.

But not everybody seems to understand that working with consumers in the pharma industry differs from working with consumers in other industries in important ways. If you let inexperienced marketers implement strategies that might work in other industries, you can expect FDA warning letters, or worse, to land on your desk. Does this mean patient engagement is dangerous or a bad thing for companies or patients? Of course not! What it means is that biopharma marketing requires an approach, expertise, and infrastructure that are specialized. A Patient Ambassador® Program is not like running any other speaker bureau. A patient video is unlike a consumer review, and a patient advisory board is unlike conventional market research. To a layperson, the difference may not be instantly apparent, but regulators can tell what is what and will enforce their rules.

Efficient Compliance

First, the agency handling patient engagement must be familiar with the regulatory rules and obligations that apply. This starts with thorough training. From adverse event reporting to privacy protections, from fair balance to approval processes and honoraria, teams can only be successful in this if everyone receives training on how to handle any given situation. This requirement extends to all members of the organization, not just those directly interacting with patients. These trainings also need to be regularly updated and refreshed annually.

Second, your patient engagement agency also needs to invest in the technical infrastructure that enables team members to efficiently fulfill or even automate their regulatory duties. It can’t work if, for every adverse event, the exact reporting procedure has to be reinvented or rediscovered by someone who hasn’t submitted a report before. It also won’t work if compliance with GDPR is left to individual team members to sort out which piece of data needs to be purged on any given day.

An Authentic Perspective

Third, beyond the rigidity of regulatory compliance, your agency must also understand the softer, yet equally vital, nuances that come into play when working with patients. Your initiative must emphasize authenticity over brand promise. With consumer goods, it’s commonplace to market with a brand promise that’s aspirational and exaggerated: By buying this or that beverage, car, or vacation, you hope to get closer to—or become a little bit more like—the person you see in the commercial. Drugs are no status symbols, and nobody wishes to become a little bit more like a sick person. You’re not interested in being enticed by someone who doesn’t know anything about your condition, no matter how good-looking or otherwise admirable they may be. The perspective that counts is that of people who know what you’re going through. Most of the time that will be other patients or caregivers. Actors and models have no place in this unless they also happen to be real patients.

Finally, the team you put together must treat patients like the human beings they are. This includes being realistic in expectations and anticipating limits of any kind: Mobility, cognition, fatigue, dietary restrictions, vision, hearing, and emotional trauma are some of the factors that commonly play a role. If you expect a patient or caregiver to open their heart (or home) to your team, make sure you enter with respect and leave things the way they were. You don’t want to roll up with a crew truck and run over the patient’s manicured garden (figuratively or literally). You also don’t want to rush patients along or disrespect them with insensitive lines of questioning. You’re not dealing with career talent but with individuals who can provide tremendous value if you allow them to show their true selves.

Setting a Standard

Companies and executives find themselves in very uncomfortable positions if their teams and vendors neglect to take care of important steps like these that keep the organization safe. Incidentally, by safeguarding their reputations and legal compliance, biopharma teams also happen to serve and protect patients’ interests, so it’s a win-win. Nobody wants to be on the front page of the Wall Street Journal for the wrong reasons. Companies that manage to strike the delicate balance between assertive market presence and steadfast legal and ethical adherence do not just avoid the ignominy of negative press—they set a standard for the industry. By fostering a culture of compliance, championing patient-centric approaches, and continuously innovating on engagement strategies, biopharma entities not only propel their brands to the forefront but also underwrite the narrative of their own integrity.

Walking the tightrope of biopharma marketing requires a blend of agility, foresight, and unwavering ethical commitment. Compliance and patient satisfaction aren’t lofty goals, they’re the foundations of success, the cornerstones of marketing excellence. That’s how pharma marketers extend career highs and mitigate any potential lows.

Oliver Portmann


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