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Preparing to Launch: Navigating the road to PDUFA

Whether you’ve been through it yourself or have only heard tales from co-workers, you may have heard that preparing for PDUFA as a marketer can be intimidating. The volume and pace at which you will work is unmatched, so what can you expect and how much of it can you actually plan for?

On average, the FDA approves approximately 20 drugs a year, and as a pharmaceutical marketing/advertising professional, there’s a good chance you’ll find yourself preparing for the herculean task of executing the campaigns that support the launch of a new drug. PDUFA (Prescription Drug User Fee Act) is an FDA process, and the culmination of months and sometimes years of hard work coming to an end. It’s when your broad strategy and detailed tactics go to work for patients, HCPs, and the brand. 

If you’re new to the industry or a launch, relax; no one expects you to know it all on your first go. Read up on the approval process and ask around internally at your agency to gain as much knowledge as you can from someone who’s been in your shoes before. Remember to lean on your teammates and learn along the way. After two consecutive launches, there are a few things I wish I knew beforehand that I plan to incorporate from Day 1 on my next go-around: 

  • Expect the unexpected. It is likely that the remit of your role will change at least once before launch day. Brand strategies evolve and client-agency relationships may grow. The safest way to approach this, is understanding that what you know to be true today, may not be true tomorrow. Learning to greet every day with flexible expectations is a penny in the bucket of the things you can control, and you’re going to want to cash those in when you can. 
  • Overcommunication is key. Brand teams often bring on different teams across the industry to ensure category experts are involved. Collaborating with these teams yields consistency and open lines of communication that will only propel everyone forward. While KPIs can still be achieved with a more siloed approach, behind the scenes collaboration positions every team in a more favorable light, reducing the probability of a disjointed approach. 
  • Get the full picture. Request time to review and prioritize launch assets with all agency partners and brand stakeholders. If you’re lucky enough to have a relationship with the review team on the account, hearing their take on how they prefer the day will go will be crucial. 
  • Establish a team lead and practice for what’s headed your way. Working internally to establish a PDUFA captain for all day-of communications will optimize the process. Things will be moving quickly, and you’ll be communicating with stakeholders outside of your day-to-day brand team. Communicating with one individual will reduce confusion both externally and internally. Once you have an idea of the asset prioritization and a team captain, consider building in a dry run before the big day to see if there are any speed bumps in your process. Act as if you’ve received changes, and actually work to update and create a new submission. This proved to be extremely helpful in pulling off a successful virtual PDUFA at the onset of the COVID-19 pandemic.
  • Keep it personal and nurture client relationships. This goes without saying, but I’ll offer some advice on approaching your clients during a launch. Here at imre, our core value is empathy, and it’s embedded into everything we do. Keeping empathy at the forefront of client relationships means remembering that on days where we cannot keep up with our inboxes, our clients are likely feeling that tenfold. Approaching conversations with clients with “How are you feeling?” cultivates trust and a sense of understanding. 

Above all, have fun and enjoy your team. The road to launch is long, and the days can feel even longer. There’s no hiding that the launch grind is not always rainbows and butterflies and being honest about that can bring some levity to the situation, when needed. Trust and believe that your campaign will be successful. You’ll achieve brand KPIs and raise awareness all at once. 

When all is said and done, it is important to realize that you were a part of a team that built something to help reach patients in need. Remember to approach this time as fleeting, because it is - even if it doesn’t feel like it. When the dust settles, the campaign you created will live on (at least until LOE), even when your time with this team comes to an end.


Author: Gina Turdo-Orner (Account Director – imre Health)

This article was created in collaboration with the sponsoring company and our sales and marketing team. The editorial team does not contribute.