Marketing while regulated: a creative’s guide
Want to give your creative marketing mind a workout? Embrace constraints. Meaningful ones, not just micro-budgets or Twitter character limits. The kinds of strict regulatory scrutiny faced by drug developers, tobacco companies, and alcohol purveyors, all of whom must walk a considerably narrower path than your average marketer.
Granted, many of the agencies and talent in those fields have developed it as a specialty, but being prepared to work under serious constraints is not just a hypothetical exercise. Changes in public priorities can bring regulatory scrutiny into a marketer’s kitchen in no time flat—see the financial crisis and the vastly different playing field for mortgage products today. And emerging markets, such as cannabis marketing, represent (if you’ll pardon the pun) greenfield opportunities for marketers willing to dance through a wildly shifting and largely unpredictable minefield of local and national regulations and prohibitions.
I asked Dale Cooke, who serves pharmaceutical and medical device clients as president of PhillyCooke Consulting, for his insights into managing the challenges of customer communications when regulators are watching every move.
To find creative, compelling, and compliant solutions for a regulated industry, you’re going to need to buy in. Cooke has that down. He values the message his clients want to convey, and even though he aids from the outside, he understands the very high stakes they face if anything goes wrong.
“The information they provide addresses some of the most important and intimate details about human beings: how they and their loved ones live,” he says. “And the consequences for violating FDA regulatory requirements for the manufacturers of prescription products are severe, potentially leaving them liable for billions of dollars.”
Accept your constraints.
Let another part of the business lobby for change, if you like, but keep marketing focused on the mission at hand. That mission will be subject to numerous and considerable shackles for the foreseeable future.
“What I often say to companies is that you can do everything that you need to do while remaining compliant with FDA regulations,” he says. “You cannot do everything that you would like to do and remain compliant with FDA regulations.”
Don’t assume that domain experience means regulatory experience.
Particularly in the most heavily-scrutinized fields, like tobacco and medical/pharma, outside agencies have deep roots and experience in those industries, meaning that the CMOs in those fields see the same names in pitch meetings quite often. But that doesn’t mean agencies are necessarily on top of every minute regulation.
“The understanding at agencies ranges from nonexistent to extremely sophisticated,” he says. “Part of the reason I and my service offering exist is that for the most part, agencies do not have the internal expertise around all of the regulatory requirements.”
Scrutinize credentials when building a team.
Every regulated field is different. Snack food makers have to answer to government authority, but that doesn’t make them qualified to take on tobacco regulators.
“You don’t want to be like people who say, ‘We’ve created software that helps nuclear facilities, so obviously we have experience in regulated industries,’” he says.
Build a collaborative, well-educated team.
The review-and-approval process in a regulated field needs much more discipline than a typical brand newsroom. Reviewers need to be the most careful and detail-oriented minds in the chain, with as full an understanding of the guidelines, rules, and precedents governing the industry. Beyond that, creative teams can be fully aligned and informed of regulatory requirements, or they can be allowed to throw aggressive ideas into the hopper to later be shut down.
Cooke favors the former approach, as over the long run the two teams will be more likely to take aggressive and unproductive views of each other if most ideas must be rejected for technical reasons.
“Pushing the envelope puts an undue burden on the reviewers to prevent things from going wrong, and sets up an inherently adversarial relationship: ‘I want to do X, and you won’t let me,’” he says. “When the process is functioning properly, everybody has the same goals: getting good information to the people who need it.”