The FDA’s Objections to Pharma Promotion Are Going Beyond Ads to Target PR Tactics, Too
This is a snippet of today's Cost Curve Apex newsletter, the premium version of my daily email missive. To get on the list for Cost Curve, click here.
I swore I wouldn’t overdo it when it came to the topic of DTC advertising restrictions, in large part because the success or failure of any policy limiting advertising has nothing to do with the merits of the idea and everything to do with what’s legally acceptable.
So, on that basis, it’s worth reading the new Hyman, Phelps & McNamara blog post on the lessons they took out of the now-public warning and untitled letters on DTC made public this week. The HPM folks made a great effort to read between the lines, and it ends with a heartfelt defense of empowering portrayals of patients.
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It’s worth revisiting the subject for a second reason, too: The FDA’s push here is not limited to DTC advertising. There’s a concern, too, about a broader set of promotional tools.
That’s worth noting because there’s been some commentary that, perhaps, the attention of the FDA on advertising is an opportunity for industry to rethink how it talks to the public. I have talked to some communicators this week who believe that the wisest course is a pivot to tactics that tend to be more on the PR side than the advertising side.
“The heart of effective pharma communication is not louder ads, it is clearer and more human ones … our job as communicators is to ensure messages stay empathetic, easy to understand, and supportive of patients rather than overwhelming.”
Yet the FDA reserved special scrutiny for PR-oriented tactics when they began highlighting problematic promotion this month. The only pharma companies to receive warning letters (as opposed to the less-serious untitled letters) received them for PR-like activities. In one case, it was sponsored content, but at least three other letters involved what seemed like standard-issue broadcast journalism where the companies had no editorial control.
I don’t have a legal take here (that’s what in-house counsel is for!), but I’m really hoping this kind of thing doesn’t have a chilling effect on the conversations that are true and constructive for patients.
It’s hard enough for reporters to tell these stories … I fear there may be some pressure now to script company experts to within an inch of their lives.
Which isn’t going to do anyone -- especially patients -- any favors.
Global Health Advocate, Entrepreneur & "Every Patient's Friend" 🇺🇸+🇦🇺
6dPatients see DTC drug ads for what they are: glossy marketing that entertains more than it educates. The fancy production doesn’t build trust, it breeds confusion. Hats off to the ad agencies for selling these campaigns and to the media executives who’ve raked in billions airing them, they’ve mastered the art of selling airtime. But the ~500,000 patients we represent have always told us that they want something different: plain language, real experiences, and resources that actually help them navigate care. Until pharma shifts from pushing ads to fostering engagement, patients will keep tuning out. #SkipAd
Bay City Capital, Managing Director
6dFree speech is important for everyone. Self expression is a fundamental human value. As the Supreme Court has recognized many, many times limits on free speech must meet a very high standard. These tests protect distasteful speech, and -- unless narrow exceptions are applicable -- they protect lots of speech few of us want to see. Let me give you a hypotetheical drug ad example. Let's say a company hires a celebrity endorser who has the exact disease treated by the drug and what they say on camera is fully accurate. Now assume the celebrity is doing their regular job like dancing, acting, swimming or playing golf. This is not false advertising nor does it claim that taking the drug will make patients experts in --or even competent at -- the depicted activities. Focused government enforcement actions to prevent fraud are fair game. But acting like a Nanny State assuming patients aren't smart enough to tell an ad from a fantasy.