Navigating the Road to FDA Marketing Approval with Smart & Time-Tested Communications Approaches

Health and science communications are a niche within a niche, and navigating FDA marketing approval is a specialized function. All communications professionals carefully hone language, messages, and media outreach to enhance the visibility and credibility of their organizations while protecting their reputations, industry professionals must do so within the constraints of the regulatory agencies that tightly govern the biotech and pharmaceutical industries.

Communications Phases for New Drugs

Let’s look at how the arc of biotech and pharmaceutical communications changes over the course of drug discovery, development, and regulatory submission to launch and commercialization. Messaging and positioning evolve over time to include more specific target audiences. New messaging is layered on top of earlier talk tracks providing updated information and data collection, affecting target product profile.

• Most pre-clinical companies, involved primarily in drug discovery and scientific research, need to introduce the medical problem and their solution to that problem to investors, potential business partners, scientists, and clinicians.
• Once companies reach the clinic, they need to expand messaging, articulating their story more fully to the medical community. Engaging medical key opinion leaders and pursuing corporate thought leadership become increasingly important as validation of their approach. Late-stage clinical trials are an opportunity to begin introducing the investigational product to patient advocacy groups, setting the table for a potential launch that would benefit the groups’ patient and care partner constituents.
• Upon submission of an investigational product to regulatory bodies such as the FDA or the EMA, communications shift again in specific ways.

Nearing the End of Clinical Trials Proves Tricky Time for Communications

Communications for late-stage clinical companies are tricky due to the possibility of approval or disapproval from regulatory agencies and all eyes on the company’s communications. As companies approach regulatory submissions, they often deploy as broad a swath of communications as possible, from earned media, social postings, and thought leadership initiatives to controlled and paid content. But once the regulatory submission is made and accepted for filing, significant constraints kick in.

Corporate discussion about the product must be very conservative and non-promotional, although within 6 months of anticipated approval companies may add “coming soon” to their asset’s communications. Regular, company public communication still works so long as it’s consistent with prior cadence of news flow.  It is smart at this stage to lean into peer-reviewed publications about the product’s Phase 3 data coupled with disease awareness information.

Even though messaging about an asset under regulatory review must be restrained, the months leading up to a regulatory decision are very busy for the health and science communications team. Potential FDA marketing approval and product launch demand extensive preparation of many tactical elements that will be held until approval including:

• Multimedia press release
• New product website
• Revisions to corporate site and presentation
• Q&A
• Product fact sheets
• Interactive content such as B-roll and KOL videos

Regulatory Approval

Upon marketing approval from the FDA or EMA, there is a flurry of activity to ascertain the mandatory communications boundaries that the agency has set; these are not fully known until approval. For example,

• What specifically is the product approved for on the label?
  • Are there sub-populations of patients for whom the drug is particularly recommended, or ones for whom it is not recommended?
• Is there a “Black Box” warning identifying serious dangers the drug could pose?
• The label from the regulatory agency must align with all public-facing materials.

After adjusting all previously prepared launch communications to align precisely with the mandates of the product label, companies need to issue and pitch an embargoed press release to a strategically targeted group of media. For the first time, the company may introduce the drug as a branded product and indicate, within the constraints of the label, how it may be used. Now is the time to lean in on previously established media relationships and KOL and/or patient advocacy friendlies, leveraging a multimedia press release to capture as much attention as possible.

The new product website and a revised corporate one should go live, and corporate management will want to congratulate and recognize internal staff for a tremendous job well done using internal communications vehicles and perhaps a company Town Hall.

Commercialization

Once a drug has been approved for marketing, communications opportunities expand significantly. Relationships developed with reporters over the course of the drug’s development remain important to continue to build the share of voice around the drug. The health science communications team can expand to consumer health media and social media outlets. Generally patient experiences become a big part of the story – as personal testimonials are communicated through media, the product website, patient advocacy groups, and satellite media tours, and so on.

The focus tends to shift to the drug’s clinical impact, as articulated by clinicians and patients, with less discussion of the underlying science.  Over time, there can be opportunities for HCP education via accredited webinars, panels, and peer-to-peer sessions at professional conferences, and of course continued thought leadership opportunities ensuring the drug is included in ongoing conversations about treatment options.

Depending on the disease state, companies often develop bespoke visibility campaigns with patient advocacy groups to raise the profile of the drug with the patient population that stands to benefit from it – an approach that benefits the advocacy groups as much as the company.

The Wrap on Navigating the Road to FDA Marketing Approval

LaVoieHealthScience is dedicated to supporting clients that bring lifesaving and disease-altering therapies to patients. We partner with companies to connect their medical and scientific breakthroughs with the world from early pre-clinical scientific work to clinical trials and finally to regulatory marketing approval, launch and commercialization. Every disease state is different, but the overall communications efforts of health and science companies are reasonably consistent over the course of their development. We leverage our extensive sector experience and long-standing relationships that span over two decades while also considering current trends. Combined with a modern perspective, we excel in unraveling complex communication problems within the domains of health and science.  Wherever you are on your journey, we’ve got you covered.

Contact us to learn how our purpose and value-driven approach seamlessly connects our clients with their stakeholders.

Written by: Harriet Ullman and Katie Dodge