In pharmaceutical marketing, the journey from drafting a drug label to achieving launch readiness is more of a marathon than a sprint – fraught with regulatory complexities, strategic missteps, and operational hurdles.
Industry data shows that many drug launches in the U.S. fail to meet expectations, with sales performance up to 42% below benchmarks and more than half failing to reach $250 million in their first year.[1] A key reason is that the marketing teams often struggle to align their strategies with approved labeling and compliance requirements, making it harder to achieve launch targets.
As pressure builds in today’s evolving pharma landscape, many turn to AI to streamline processes and improve outcomes. While AI is reshaping how work gets done, the real drivers of launch success remain unchanged: strong leadership, clear communication, and efficient project management. These fundamentals are often overlooked, yet they are more critical than ever.
Leadership challenges in pre-launch claims development
- Effective communication across teams
One of the biggest hurdles for marketers is maintaining clear communication across cross-functional teams while building flexibility into the process. At least twelve months before a drug launch, marketing teams begin drafting claims based on the draft label, which serves as the foundation for all marketing assets.
However, the term “draft” often triggers hesitation from regulatory, legal, compliance, biostatistics, safety, and medical teams – many of whom prefer to wait until final data is available. This puts marketers in the position of needing to convince everyone of the urgency of the process and push cross-functional teams forward, even as questions arise about the validity of early claims development.
For example:
- The necessity and accuracy of a claim about symptom improvement at 90% may be questioned by regulatory and biostatistics teams, before the data is finalized.
- Marketers must clarify that while the exact figure could change, it’s unlikely to impact the overall validity of the claim or marketing materials like an eDA slide.
Most claims are expected to align with the final label, and even if one is invalidated, the marketing team can pivot effectively since many claims are being reviewed during the draft approval process. This illustrates a larger, complex process that can span up to 1.5 years, emphasizing the importance of strong leadership in successful navigation.
- Navigating regulatory constraints
Regulatory and legal teams are tasked with minimizing risk and ensuring all claims are supported and balanced. However, an overly cautious approach can sometimes go too far, leading to unnecessary delays over a single word. In pharma marketing, brief meetings can unexpectedly extend over weeks or even months, debating whether to use “kill,” “eradicate,” or “reduce.”
These nuances can significantly impact the tone and effectiveness of marketing materials, and pharmaceutical marketers invest considerable effort into getting it right. After all, pharmaceutical products must be sold in a clear, compliant manner – though “clear” is often easier said than done.
When regulatory feedback requires significant pivots, especially under tight launch timelines:
- Marketing team morale can drop
- Overly conservative approaches can also stifle creativity
Marketers may shy away from bold or innovative messaging, opting instead for safer, more conservative language that reads like a copy-paste from the label – accurate but unmemorable. This is problematic, especially with HCPs who have limited time to absorb information and decide if they want to learn more.
Proposed solutions for marketing success
Navigating these challenges, pharma marketers must foster stronger alignment with medical and regulatory teams. Strong leadership that builds confidence from the top down is critical to navigating this complex process.
Often, investing in external consultants with specialized expertise to manage communication and coordinate workflows can alleviate pressure on the marketing team and introduce fresh perspectives. After all, even champions need coaches to identify blind spots, regardless of skill level.
Here are actionable strategies:
- Build trust through team workshops: Invest in team-building workshops focused on understanding personalities and improving interpersonal communication. This helps reduce friction and build empathy across functions, critical for smooth collaboration during launch.
Since such workshops are difficult to run effectively using only internal resources, bringing in expert consultants has proven to be a smart investment.
- Establish regular cross-functional updates: Leadership should implement monthly cross-functional team meetings, led by a professional project manager, to ensure alignment and transparency throughout the development cycle. Effective project management is essential for this process.
While some pharma companies have internal project management capabilities, more often than not, engaging a professional project manager – even for a short period – is an investment that significantly increases the chances of a successful launch. It may seem simple on the surface, but its impact on the launch outcome is greater than many realize.
- Create a deal-breaker culture: Introduce a clear, step-by-step process that enables teams to identify and flag only critical issues posing real compliance risks, minimizing debates over minor details. This helps maintain momentum and avoids unnecessary delays. Introducing this cultural shift through third-party facilitators can help drive smoother adoption by internal teams.
- Develop differentiated value propositions with regulatory and medical teams: Marketing teams should focus on developing tailored, visually engaging assets that resonate with HCPs, but this must be done in close collaboration with regulatory and medical teams from the start to avoid time consuming revisions or rejections later on.
According to an online report, HCPs engage more with content that clearly explains the mechanism of action, includes peer insights, and is backed by strong clinical data. Companies using advanced analytics to personalize outreach have seen up to 45% higher market penetration and 23% better launch outcomes.[2] Whether through congress materials or MSLs, the message should spark scientific curiosity.
Conclusion: Invest in your people and industry experts
Successful marketing at launch demands strong leadership that balances compliance with creativity while fostering clear communication across teams.
Such leadership becomes especially critical when navigating complex regulatory and cross-functional challenges, requiring the ability to maintain momentum without sacrificing accuracy or innovation. To support this, investing in structured processes, expert guidance, and early collaboration between marketing, regulatory, and medical teams can significantly reduce delays and improve message effectiveness. A unified and well-led team is ultimately vital to delivering compliant, compelling marketing that drives launch success.
References
- Overcoming Pharma’s Launch Performance Problem (iqvia.com)
- Strategic HCP Engagement for Product Launch (qpharmacorp.com)
