Communicating Along the Regulatory Runway

FDA approval is a big deal, but if it’s the only regulatory milestone you’re sharing with your audience, you’re missing key opportunities to build receptivity and awareness in preparation for FDA approval day. The road to FDA approval provides a meaningful communications runway to help educate key audiences.

FDA filing acceptance, the calling of an FDA advisory committee – they’re all just as important to your brand’s story.

These regulatory milestones provide a steady cadence of communication opportunities that build momentum over time. Building off momentum during Phase 2B and/or Phase III data presentation communications, you can use each of these moments in time to further strengthen the foundation, reviewing the current unmet need your drug is addressing and sharing the “why” behind your investigational product.

Why is this important?

Before announcing FDA approval, there is a significant amount of legwork involved to make sure key stakeholders are aware of your clinical data and your company’s focus and intent on this particular disease category, class of drugs, and so on.

Whether this is your first pipeline product out of the gate or the latest to enter an already established business unit or product portfolio, by actively sharing and participating in the discussion of these milestones as they happen, you help steer the narrative and prime the environment for the moment your drug is approved and launching on the market.Click To Tweet

PR is often the first discipline that is able to be proactive and vocal during this time period – meaning it plays a critical role in brand marketing’s preparations. PR can not only help set the tone for healthcare professional education or patient awareness down the line, but it also helps align all important team members internally around the core messages and platform for the brand. This is then pulled through across all other marketing tactics, such as advertising, CRM, and so on post-approval.

That said, not every milestone needs the same amount of emphasis in order to be marked a success.

Instead, your communication strategy should take an inverted pyramid approach.

FDA Filing Acceptance

At this stage, your pyramid is at its narrowest. This milestone will only be relevant to a small group of people who are interested to know your drug is on the horizon and has reached this meaningful stage of your R&D pipeline. Depending on the disease category and climate, these are mostly like analysts and industry executives, medical thought leaders and societies, and perhaps patient groups for specific underserved disease categories awaiting new solutions to hit the market.

Conduct highly targeted outreach to these groups to share the news that the FDA has accepted your filing, based on your Phase III data and other clinical findings. This announcement not only “starts the clock” toward your action date, but is also an opportunity to remind your audience about your drug’s clinical data/how if approved in what way would your drug help solve a currently unmet need.

FDA Advisory Committee

Your pyramid gets slightly wider here, as a larger group of stakeholders become interested in hearing an advisory committee’s point of view. While ad comms do not occur as a default, when they do, the committee’s feedback is of particular interest to thought leaders in the industry, reporters who cover FDA activities and pharma business milestones, depending on the disease category and patient groups.

Scenario planning is extremely important for this phase. Since the ad comm is a public meeting, webcast and then archived online, it is important for each sponsor company to think through the various comments and questions that could arise. The committee’s final vote is also an opportunity for not only the FDA but your key audiences to hear additional commentary and interpretation of your filing, and how it counters to what you have said in the past. This adds a layer of complexity to your planning – your strategy must be both proactive and reactive.

Ignoring the potential for negative feedback could leave you scrambling to respond. Think through all possible scenarios, determine the right spokespeople and craft messaging, just in case.

An agency partner can be useful in this process. Tap into their breadth and depth of experience across these milestones to determine all the potential outcomes, both good and bad.

FDA Approval

Once your drug is officially FDA approved, more robust marketing/communications efforts can begin. The FDA approval announcement is a key media milestone that should invoke a comprehensive plan. Consumer media, trade media, thought leaders, potential customers – this regulatory milestone is the moment to connect with them all.

At this stage, the storytelling and brand building you did along the way will pay off. Searches will show a consistent narrative throughout your regulatory history, making it more likely that FDA approval coverage will incorporate your key messages.

More often than not, no news is not good news. Understanding how to maximize each of these touchpoints with the right stakeholders is critical for launch planning and being efficient with resources. By capitalizing on seemingly small regulatory milestones, you can build momentum for a big market entry splash.

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