As researchers work at a never-seen-before pace to develop a safe and effective COVID-19 vaccine, the FDA has taken center stage. Founded in 1906, the Food and Drug Administration is a federal agency of the Department of Health and Human Services. The agency is responsible for protecting the public health by ensuring the safety and efficacy of human and veterinary drugs – which is where its role comes into play with the current race to find a COVID-19 vaccine.
And of course the FDA’s medical purview is much broader than vaccines. It is also responsible for regulating medical devices – everything from at-home genetic test kits to implanted heart pumps. For many companies, the approval milestones are cause for promotion and communication – to investors, to customers, to employees. Regulatory milestones include approval to begin rounds of clinical trials, clearance to commercialize and sell to consumers and approval to go to market via health care professionals.
Each of these milestones is an opportunity to communicate but, the “when” of communicating the news is where it becomes tricky. That’s because companies are often completely uncertain of if or when approval will occur. What’s more is that it is not out of the ordinary for the FDA to issue its own press release about a milestone, with or without a coordinated effort from the product’s company.
So how does a company, whose business success relies on leveraging regulatory milestones, prepare especially in a media landscape that is unpredictable and still dominated by coronavirus?
Here are a few tips to keep in mind:
- Be ready to jump. Once the submission to the FDA has been completed, it’s time to start getting your story organized. Identify and train spokespeople and patient stories; gather data that demonstrates efficacy and need. Draft your own press release and other media assets, including multimedia ones.
- Prioritize trade outlets. If you feel like COVID-19 is still dominating consumer and business news outlets, you’re right. Newsrooms continue to focus on the pandemic and how everyday life is adjusting. Lately, the coverage has been on how schools are or aren’t opening. As we approach the colder seasons – and their respective holidays – the coverage is expected to shift to those topics. Trade media, however, is tracking regulatory milestones, even if they are not related to COVID-19. These outlets may be your best for coverage once your product is approved or cleared.
- Lean on the full PESO model. Earned media is just one leg of the PESO stool. Paid digital, sponsored content, satellite media tours and desk side briefings are all tools in your PR toolbox. There has never been a more important time to use all of the tools available to you in order to amplify your message far and wide – and deep among those that matter most.
Regulatory milestones are major accomplishments. They help inform the safety and efficacy of your product. So seize the opportunity to communicate to your business and medical stakeholders – just make sure you’re ready for it.
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