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FDA Cracks Down on Unbranded Promotion

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It might make me a pharma geek, but I like watching what FDA/DDMAC is citing in its letters to pharma on promotional activity. It’s always interesting to me because with every untitled or warning letter for every brand, implications can be far-reaching. Just in the first quarter of 2010 alone, FDA issued 21 letters — a number putting them on track to quadruple the total number of letters sent in 2008. And the latest letter sure got my attention, as well as the attention of other bloggers … and no doubt pharma marketers and their regulatory folks.

On Tuesday May 4, FDA posted a letter to Novartis citing two unbranded Web sites (http://www.gistalliance.com/ and http://www.cmlalliance.com/ ). Neither site is currently live, and even the WaybackMachine doesn’t have them archived. But FDA gives us plenty of information about what they thought about them anyway …

In the letter, FDA states the Web sites were in violation because "they promote the drug for an unapproved use, fail to disclose the risks associated with the use of Gleevec and make unsubstantiated dosing claims, (which) can put patients at higher risk of experiencing adverse events."

The thing is, neither site mentioned Novartis’ oncology drug Gleevec by name. Not once.

Carrie Martin over at the FDA Law Blog pointed this out in her excellent post,

DDMAC’s detective work to link the alliance websites to Gleevec included the following: comparing the alliance websites to Gleevec’s product website and finding them "perceptually similar" in terms of color schemes and layout, locating Novartis logos on the alliance websites, finding direct links to the Gleevac product website on the alliance websites, reviewing the publications referenced and finding one that "recounted" a pivotal trial from one of Gleevac’s approvals, noticing that footnotes referenced imatinib (Gleevec’s established name), and—somewhat surprisingly—looking into the registration of the alliance websites and finding them registered to Novartis AG.
FDA must not have liked having to do all that detective work. The letter’s tone is extremely accusatory and serious, demanding the usual plan of action but also corrective action to "disseminate truthful, nonmisleading, and complete corrective messages about the issues."

I’ve blogged about leveraging unbranded approaches in the past, and PharmaVOICE just did a storyon the growing influence of unbranded promotion. And the point has been made many times that an unbranded approach is the most comfortable and appropriate when it comes to social media. But it seems the FDA is clamping down on the gray area between unbranded and branded pharma marketing. So what do we do now? And where should the lines be drawn?

Our account service teams often are involved in discussions with our pharma clients, especially marketing and regulatoryexperts- about where the line should be drawn. There’s no single or easy answer to the questions that arise:

  1. How close of a link between unbranded and branded is too close?
  2. Can branded and unbranded share the same color, shapes, or other graphic elements? (this was addressed in the Gleevec letter)
  3. If the drug is the only one offered in its class, how conservative should we be with unbranded promotion? Does doing unbranded in a one-drug categoryinherently imply branding?
  4. What are our competitors doing in the unbranded space, and if they haven’t received a warning letter, does that mean it’s ok?
  5. Can we discuss disease symptoms on an unbranded site that the drug does not treat? (even though, often, information on symptoms is exactly what patients are searching for)
  6. Does adding drug safety information to unbranded sites increase or decrease liability?
  7. Does mentioning the company name on an unbranded siteimply a connection to the drug? (according to the Gleevec warning letter, yes!)
  8. Can you link one site to the other? What if you use an "offsite disclaimer" when you do, does that limit liability?
  9. Can you use an unbranded banner or search ad to link to branded content? Should you?
  10. Can you send a branded email to a database that was acquired through unbranded means?

Unfortunately there’s no "Unbranded FAQ" provided by FDA that answers these questions, andcompanies are left tointerpret the rules on their own. All of our pharma clients - at the cultural, philosophical, and individual levels - hold different levels of tolerance and risk for unbranded promotion. (In my experience, it often depends on how recently they received a warning letter, and also how much influence the marketing team has over regulatory’s decisions!) I’m not an attorney or a regulatory expert. But here’s a small bit of advice I can give:

Don’t let regulatory constraints drive all of your marketing decisions.

BUT ...

Pay attention to the latest letters coming out of DDMAC. Follow the known rules. And finally, be smart about any risks you do take. Make sure they’re worth it!

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