Pharma Marketing Preparation Before FDA Approval

How do I prepare pharma marketing materials before launch without busting my budget?

Your drug has passed its phase-III trial, you’ve submitted a new drug application (NDA) to the FDA, and they let you know they’re filing it for review. Awesome! What now?

Obviously, FDA approval isn’t guaranteed. Not only that, the time between the beginning of the review process and approval can vary or change. If the review process seems to be going well, you’re on the clock to develop a go-to-market strategy. Since the FDA calls the shots about when your pharmaceutical product can launch (and exactly what you can say about it), pre-launch preparation is notoriously tricky.

Big changes to a drug’s labeling can take pre-launch materials back to square one, so there’s always a risk to starting before labeling is finalized. That said, you can’t wait until FDA signoff to build a brand, test messaging, or create core materials. It’s a delicate balancing act between under-preparation and over-preparation, with a successful launch and your marketing budget at stake.

In our experience, there are cost and time efficiencies for core pharma marketing materials that make the balancing act a little easier. While no amount of strategy will completely spare you the headaches that come from a last-minute FDA pivot, a structured approach can help. The goal of this article is to explore efficiencies that can help you create a viable, on-budget strategy before launch. One caveat—this applies to conventional marketing channels (targeting patients, providers, pharmacists). Pharma market access, for example, needs to play by different rules.

What about market access in pharma?

An ace strategy, full stable of effective pharmaceutical messaging, and compelling creative are powerful—but they can’t persuade a patient to pay hundreds extra for the drug at the pharmacy because their plan doesn’t cover it or puts it on a lower tier of coverage. That’s why market access strategy and materials should be on a totally different level of priority before launch.

I can’t overstate the importance of having a strong, proactive approach to market access. Getting a drug placed advantageously on major formularies is foundational for the success of all your marketing efforts down the road. Payer presentations and monographs benefit from the polish and insights that an expert pharmaceutical advertising partner can provide.

How do I know which pharma marketing materials should be on the to-do list before launch?

Below I’ll outline core pharma marketing materials, list some nice-to-have, stretch items may be feasible if your budget and timeline allow, and note which materials warrant more of a wait and see approach:

Must Haves

Brand identity – Developing a brand identity (brand name, logo, colors) is always square one. If you don’t already have one, you need it before you start anything else. Read more on that here.
Core messaging for providers and patients – Based on disease state information, your indication, and study results, you should start developing and testing messaging across your desired audiences. This is a lengthy process, so starting early (even if there are changes to the labeling) is crucial.
ISI / brief summary – These fair balance pieces must go on marketing materials that have promotional copy, so you need to start developing them according to FDA guidance. Labeling changes can be easily pushed through on these with minimal expense.
Basic launch webpage – We’ve seen brands rush to get a full website ready before launch, but the cost associated with doing so before labeling is finalized is just one reason why we don’t recommend it. Another is the long internal review and regulatory process. Save building that full webpage for later and create a branded, polished single-page website for each of your core audiences that showcases branding and simple core messaging instead.
Press release copy – This is another easily edited item that builds on your core messaging and data, so there’s little risk to developing it ahead of time.

Nice-to-Haves

Product photography – Photoshoots are expensive, but if you have mostly settled on your packaging look and feel with no complications anticipated from the FDA, it’s good to have actual product imagery on your materials. For many brands, this could be considered a core item. For others, it’s not as crucial.
Basic announcement letters or eblasts – Having launch announcements for providers and pharmacists ready to push out at launch is time-sensitive. If you’ve got the bandwidth and budget, these aren’t too expensive to create or edit.
Simple print and/or digital ad – Adapting and pushing out a single branded ad over multiple mediums is a good way to spread brand awareness. At launch, you don’t need lots of variations—just one ad per audience will do. Having product photography makes these work even better.
Core detail aid for providers – Your core detail aid for healthcare providers will typically be a touchstone for your provider collateral moving forward. If you want your reps prepared from day one, consider getting this one started early. Plus, how you talk about your pivotal study data isn’t likely to change too much before approval. Extensive edits to creative and content can be pricier in a designed piece like this, which is why this is a nice-to-have for launch.

Wait and See

Influencer content and agreements – Locking down influencers and creating content to push out on social is its own regulatory minefield, and you don’t get that money back if there’s a big change to your labeling or timeline. You might be tempted to do this to build buzz ASAP for launch, but there’s just too much risk before approval.
Patient collateral – Patient pieces for doctor’s offices or download can be useful, but you may not have nailed down co-pay agreements or other commercial aspects before launch. When these things change, they can confuse patients. Wait until you have this stuff set in stone so you can create the most effective and accurate patient collateral possible.
Fully-fledged website – Websites are crucially important—but they’re also complicated. Labeling changes can throw a wrench in the works of a website that’s already being developed and set the process even further back. Wait to finalize your messaging and commercial agreements so website development is as simple as it can be (which still isn’t very simple).
Kickoff commercial – It should go without saying, but shooting video is massively expensive. Reshoots, even more so. Wait until labeling is finalized and you’ve got your messaging polished to save yourself a pretty penny.

Need more insight on how to navigate the early phases of commercializing or launching a product? Get in touch with one of our pharma advertising experts. In the meantime, check out some strategies for executing messaging for potentially delicate or embarrassing indications.