Cari Tornatta, Account Director
Most of us are familiar with pharma ads. You know the ones — a laundry list of side effects and contraindications is rattled off while actors swim, golf, ride a horse, or sit in a bathtub on an ocean cliff. They all end with, “Ask your doctor if this miracle drug is right for you.” As a casual observer, it probably seems silly to list out all the possible outcomes, but this is a perfect example of how regulated the pharma industry is. Something as simple as replacing a word on a website requires a submission process that has to be signed off on by a medical, legal, and regulatory team before it can go live.
Not all healthcare marketing agencies have the deep knowledge or skills to work in this environment. Choosing the wrong agency can create unnecessary risk or market delays. Here’s what to look for when evaluating an agency partner that truly understands pharma marketing and regulatory dynamics.
In pharma, compliance can’t be an afterthought. Planning must start with regulatory constraints in mind, including what can and cannot be said, how claims must be supported, and where review cycles may affect timelines. It often means planning assets and campaigns many more months in advance than typical healthcare marketing deliverables. If an agency talks about compliance only at the final approval stage, that’s a red flag.
Healthcare experience alone isn’t enough. Look for agencies that have worked with pharmaceutical, biotech, or life sciences technology companies and can speak fluently about FDA regulations, medical/legal/regulatory (MLR) review, and promotional boundaries. Experience navigating these environments matters far more than generic healthcare marketing credentials.
Regulatory guidance isn’t static. Things change in the process, which impacts all advertising on all channels. What was okay to say a month ago may no longer be allowed. AI further complicates things, as complete accuracy is always required. That means doing the extra work and checking sources for accuracy and credibility outside of an AI tool. A strong partner stays current, anticipates shifts, and helps you adjust strategy proactively rather than reacting after issues arise.
The pharmaceutical industry is a global business, and delays can frequently happen that are outside of the company's and agency’s control. For example, if FDA inspectors can’t visit a manufacturing site as planned, deadlines get pushed. Months of pre-launch planning and deliverables can be tossed out the window if the drug doesn’t make it past stage III clinical trials. Your agency needs to understand these risks up front and plan accordingly.
The best agencies know how to translate complex, regulated information into clear, compelling messages that resonate with the right audiences. If your agency can make interesting, creative campaigns while staying within the bounds of compliance, you’ve found a great partner.
Find an agency that understands how to build compliance into its strategy, how to plan for regulatory realities, and how to stay flexible when timelines shift. The right partner will help you avoid risk and still market effectively.