Managing the development of your product’s label is a challenging process with very high stakes. Yet, many companies neglect opportunities they have to simplify the process and increase their odds for a satisfactory outcome. Here are a few missteps we often see sponsors make:
They Don’t Make Use of The Target Product Profile
Sponsors are not required to use the FDA’s target product profile (TPP) document, but there are good reasons to do so. The TTP provides a logical and tidy template for outlining a product label. From pre-IND, all the way through your development program, you can modify this document to build your label step by step. The FDA provides a draft guidance on the TPP. Read up on it.
They Don’t Look Far Enough Into the Future
Planning a label that will serve you well in today’s marketplace is no simple task, yet, as challenging as it may be, it’s not enough. You also need to think about what label you will want five or ten years out, when you will actually launch your product. The landscape will look much different at that time. What competitors will you have then? What are their labels likely going to look like? What can you do now while developing your label to be prepared?
They Don’t Have a Clear Vision of the Label That They Want — and the One They Don’t Want
While developing your label, you want to have a vision of your ideal, the label that would give your marketing team the most opportunity. A study of your competitors’ labels will inform that. Those competitive labels that have been most recently approved will be most valuable to you.
With the ideal in mind, you then want to create and hold onto a vision of two other potential labels:
1. One that you could live with even though it wouldn’t be ideal.
2. One that you cannot accept.
With these three benchmarks in hand, you and your team can better prepare for effective negotiation with the FDA. You’ll know definitively when you can afford to acquiesce and when you must push back.
They Don’t Optimize Meeting Logistics
You might have team members in multiple locations around the world. Travel is inconvenient, and expensive. A teleconference or video conference with the FDA will work just fine, right? It’s common practice, after all. We recommend that you don’t risk it. Consider this:
While distant team members struggle with phones and video, the clock is ticking on your meeting. If your technology breaks down, so do your communications. And consider this: The FDA might put you on hold at some point during your meeting. You can’t talk with each other during that time because the agency might come off hold at any moment.
Here’s the better plan: Get everyone into the same room. Make sure that “everyone” includes the individuals who have the ability and the right to negotiate and to veto. Prepare a room that can serve as your “war room”. Have everything you could possibly need laid out there and readily at hand.
This might mean a little more preparation for you up front, but it could save you a vast amount of challenges in the end.