OPDP and Me
I don’t think I’m revealing any industry secrets when I say that pharmaceutical advertising is a minefield of rules and regulations. If the devil lives in the details, he’s got a summer home somewhere at the FDA.
Getting marketing materials for a new drug approved and out into the world takes an enormous amount of time, effort, and alignment from multiple teams, all with the goal of meeting FDA guidelines for prescription drug promotion.
There are all kinds of things those of us in the agency world have heard over the years to help us stay on the right side of regulation, such as “We’ve got to make all the copy the same size; those are FDA guidelines,” or “You can’t put those colors together, it’s against FDA guidelines.”
It’s certainly easy to imagine someone at the FDA sitting at a table with a set of calipers, meticulously measuring each word on the page to make sure they’re of equal size, ready to bring the hammer down for even a minor difference. But, after hearing these “hard and fast rules” for so long, I decided to poke around a little and see just how set in stone they really are. So, I called the Office of Prescription Drug Promotion (OPDP) at the FDA and asked whether they had any calipers.
The answer was no.
That’s not a joke, by the way. As it turns out, OPDP has a team of project managers whose job is to answer questions about promotional pieces, and you can call them at 301-796-8522. You may have to leave a message, but they usually get back to you within a couple of days. I know because I’ve called that number multiple times, both for the good of our clients’ projects and for my own peace of mind.
During the “calipers” discussion with a project manager, I asked about the presentation of important safety information (the "ISI"—aptly named, but the bane of every art director) and whether it truly had to be the same size as the smallest body copy in the piece. The upshot is, so long as it’s not egregious, the FDA isn’t going to send your client a letter just because the ISI is on the small side.
Because as high as the stakes are, the actual FDA guidelines are open to some interpretation.
Very helpfully, the FDA occasionally publishes “Guidance for Industry” documents. These are lengthy explanations about how agencies and pharmaceutical companies might approach their promotional pieces to stay compliant with the various laws that govern them. But right at the start of each of these documents is this disclaimer:
FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
And at the top of each page are the words “contains nonbinding recommendations.”
Now, don’t misunderstand me. I’m not suggesting that we should ignore FDA guidance because it’s not legally binding. That would be madness.
What I am saying is that there’s a little bit more flexibility than you might think when it comes to those details. Just a little bit, mind you—this is still the FDA we’re talking about, after all.
The FDA doesn’t want to play copy editor or design critic. They don’t really sweat your color schemes or font choices. So long as your choices fall within the realm of reasonable and prudent, you’re probably fine.
But if you’re ever wondering whether you’re doing the right thing by your client and following those stringent FDA guidelines you’ve heard so much about, just put down your calipers and pick up the phone. They’ll be happy to take your call.