PHARMA: What next for DTC regulation? by James Gardner

Those of you following along at home know that big Pharma is trying to get ahead of a suddenly hostile Congress (including Bill Frist turning on them) on the subject of DTC advertising. This week they’re holding hearings on direct-to-consumer promotion of regulated medical products. Joining us from Washington DC as a guest blogger, James Gardner of One to One Interactive shares his observations on today’s hearings. James is an authority on Internet marketing and how the channel should most effectively be used by pharmaceutical and device marketers. As well as sharing his observations, he’ll also be addressing the panel and advocating for the interactive channel to be regulated differently than traditional TV, radio, and print. His agency’s past and current clients include GlaxoSmithKline, Pfizer, Roche, Boston Scientific, Schering/Berlex, and Digene.

Hello, welcome, and a big “thank you” to Matthew for allowing me to share my observations from today’s FDA hearings on direct-to-consumer (DTC) promotion of regulated pharmaceuticals and medical devices. I’m in Washington for the day to address the hearings with a point-of-view on the internet’s role in DTC promotion, but I’m excited to also provide some color commentary.

As some of you surely know, the FDA announced its intention in mid-September to hold a series of public meetings on a range of issues related to DTC marketing. The FDA’s goal, quite clearly, is to develop a new regulatory paradigm for pharmaceutical and device marketers. While the FDA has been down this path before, the political and business environment today seems more conducive than ever to having real change actually happen. In that sense, these hearings could be an important regulatory milestone.

My personal expectation, shared by many (but not all), is that we’ll see several things emerge from this process:

  • Blanket restrictions on several currently popular promotional tactics
  • Significantly clearer guidelines articulated about still-permissible tactics, and
  • Much stiffer consequences for those failing to comply with the letter and spirit of the new rules.

I don’t see an outright ban on DTC promotions happening, although some will certainly advocate for that approach. Indeed, with the DTC promotion envelope continually and aggressively being pushed by adventurous marketers, one could plausibly argue that wholesale change is both inevitable and desirable.

That said, I think cooler heads will prevail and the FDA will choose a path of lesser resistance by instead adopting many of the voluntary guidelines articulated this summer by PhRMA, the industry’s trade group. Most of their proposals were quite sensible and all would serve as a good starting point for the FDA to regain control of the DTC promotion agenda, if nothing else. A pragmatist always, I see some positive change as being better than no change at all.

For those of you new to the world of FDA hearings, here’s what you’re missing:


There’s a large podium across the front where the first group of FDA panel members are sitting. Below them, on the audience’s left, are additional panel members. Also below them, but to the audience’s right, sit the 3-4 speakers in each “wave” awaiting their turn to address the group. Speakers use a podium on the audience’s right, projecting slides on two very large television screens. If you look closely, you’ll also see that we’re using the National Transportation and Safety Board’s auditorium – hence, their “shield” on the wall behind the podium.

Speakers have 12 minutes to make their case. When their time ends, the moderator thanks them graciously for participating and helps field questions from his colleagues and, time permitting, the audience. Questions from the FDA panel to speakers are obviously allowed, but questions to the panel in return are generally frowned upon.

Kudos to the FDA — it’s all quite well organized. We’re keeping to the agenda and making good progress.

Tomorrow: Thoughts and reactions to Patrick Kelly from Pfizer and speakers from the ASHP, AARP, and other organizations. I’ll also post my presentation with the hope of stimulating some discussion!

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2 replies »

  1. Hi John:
    Good questions, thank you.
    The overall tone was — and I know this may be hard to believe — somewhat sleepy. The presenters, while representing many points of view, were generally factual, well-informed, and professional. Mirroring this, the FDA panel was polite and gracious to a fault. They seem to be searching for answers and implored everyone to speak up and/or submit materials to the docket for post-review.
    The Merck trial verdict announcement was made today, I believe. Since the hearings were on Tuesday and Wednesday, this news was not a factor. However, Astra Zeneca’s surprise announcement about their proposed approach to DTC advertising clearly caught many off-guard. In my second posting, I discuss their proposed plan and how it seemed to catch Pat Kelly of Pfizer flat-footed.
    I don’t seen the online channel as deserving exemption from regulatory oversight, but I did want to make the point to the FDA that it’s a very *different* medium than television, print, or radio. I’ve posted my presentation for comment, but my thinking is simple:
    1. It’s not intrusive like TV (who can ever forget or forgive Cialis for bringing the phrase “erectile dysfunction” into our 2004 Superbowl family parties?);
    2. It’s user-initiated and controlled (you choose to visit a website or search for health information, unlike TV);
    3. It’s potentially more effective at balancing risk and benefit information (you can review a package insert, print it for review, or use it as a jumping off point for more research, unlike TV);
    4. It’s less expensive than mass channels which, while not an FDA concern, does help defuse the issue of pharma’s multi-billion dollar media spend.
    And lastly, potentially the most important difference of all:
    Everyone would agree that banning DTC advertising on television, radio, and print would, at least in theory, prevent US consumers from being exposed to its allegedly harmful impact. Forgotten is the fact that banning DTC advertising online would only remove a currently regulated source of information and replace it with millions and millions of *unregulated* sources. Some have good quality content but many are marginal — and some are outright dangerous.
    To bring it to life — consider that Cialis alone produces 6 million Google results — only one of which is currently scrutinized by the FDA. Remove that one, and you’d still have 5,999,999 sources! Likewise for any major drug on the market.
    So … awareness of the web’s uniqueness is critical for the FDA: an outright ban on online DTC advertising could actually hurt the public interest.
    They don’t call it the “Wild, wild web” for nothing 🙂
    – James

  2. Nice post, James.
    I’m with you on the progress through pragmatism front.
    A couple of things, when you have a second.
    (A). How would you characterize the tone of these hearings in a general way? Congenial? A little adversarial, perhaps? I know it is often difficult to generalize about these things …
    (B). Did word of the Merck decision filter in this morning, if so did you sense any reaction?
    (C). I’m keen to know why you feel the interactive medium should be exempted from any new guidelines. I look forward to reading your proposals …