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Your Company’s Messaging and the FDA: What You Need to Know

Posted on January 29th, 2019. Posted by

Your Company’s Messaging and the FDA: What You Need to Know

Your leadership spends a lot of time developing and writing public messages about your company’s story — whether a press release, the corporate deck, or the script of an earnings call. And while the intended audience is often the investment community, it’s important to consider what other constituencies will read these public documents. Your competitors, the media, and even the U.S. Food and Drug Administration (FDA) will likely read your news as well.

Deciding what content should or should not be included in your public communications is influenced by a number of factors: legal materiality, how much management has guided in the past, and what metrics management is willing to share going forward. Balancing transparency with disclosure can be challenging but adding these important considerations to your process upfront can help avoid issues down the road.

Ask Tough Questions Early in the Process

When crafting written materials, ask your team tough questions that can help guide your content. Think about questions like: Are you providing too much detail about your lead asset to the competition? In future quarters, will you still be able to provide the same, consistent criteria? Is your content and messaging aligned with how you want your stakeholders to judge you?

Avoid Setting a Negative Tone with the FDA

When it comes to the FDA, always assume that they will be reading your public content too. Comments that may come across as overly aggressive, including topics like the outcome of an advisory committee meeting, may inadvertently set a negative tone with the FDA. Straining your relationship with the FDA is usually not in a company’s best interest. While potential repercussions may not be obvious, confrontation with the agency should generally be avoided. Commenting on detailed aspects of other sensitive topics, such as Complete Response Letters (CRL) or details about the ways physicians may be prescribing your drug off-label, are considered off limits.

A few best practices to keep in mind — especially knowing that the FDA is watching — include:

  • Present factual information and try not to speculate.
  • Avoid commenting on things that are not FDA-endorsed.
  • Avoid making controversial claims.
  • Pressure test messaging by looking at it from the FDA’s perspective.
  • Keep opinions limited.
  • Don’t attempt to speak for the FDA.

As an example, if you just had an End-of-Phase 2 meeting, don’t share the takeaways from that meeting too soon. Take a conservative approach and wait until you receive the meeting minutes to ensure that you are in alignment with the FDA’s stance.

Use Discretion in Public Forums

For those times when you do find yourself at odds with the FDA, publicly attacking the agency can be risky. Transparency in a public forum may not be the right place for a debate. Instead, consider taking a dispute off-line in a confidential setting, based on advice from your legal counsel.

Be thoughtful about what you share. Putting information into a public domain means you will need to live with the message that you deliver. Think strategically and examine your overall objectives. Consider how the information affects your program, the totality of your programs, and your ongoing relationship with the FDA.

By considering the strategic and long-term objectives and implications of your content as you develop it, you can ensure you’re presenting information that is valuable to your intended audience while protecting your reputation with the FDA and stakeholders. Need help developing messaging that resonates with your audience while considering secondary readers? Reach out to start a conversation about how we can help.

Patti Bank

Patti Bank is a Managing Director on Westwicke's life sciences team. She has extensive analytical experience, specifically within the pharmaceutical and specialty pharmaceutical sectors. She has a BA in neurobiology and economics from Rutgers University and an MBA from Drexel University.

View full bio   |   Other posts by Patti Bank

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