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It’s the Message, not the Medium, that Landed Duchesnay in the FDA’s Crosshairs

It’s the Message, not the Medium, that Landed Duchesnay in the FDA’s Crosshairs

August 17, 2015 0 Comments

By now, you have probably heard that an Instagram post by Kim Kardashian, promoting morning sickness treatment Diclegis, has landed drug maker Duchesnay in hot water with the FDA. The company received a warning letter from the FDA for an Instagram post the agency says: “entirely omits all risk information.” The post, which appeared on Instagram with a picture of Kim holding a bottle of the treatment, is embedded below.

“OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com.”

When news of the warning letter began to spread, it sparked a narrative focused on the perils of social media for pharmaceutical companies. It was a predictable story line. Every time the FDA issues a warning letter that has even a remote tie to social media, it renews the conversation around whether or not pharmaceutical companies can engage on social media. But here’s the thing: it’s a false narrative.

The problem in this case had nothing to do with the use of Instagram and everything to do with the drugmaker’s failure to include fair balance. Read that Instagram post again – there are several efficacy claims made without any mention of the product’s risks. If there is one golden rule of promotional pharmaceutical marketing, it’s to provide fair balance. The post did include a URL (the link wasn’t even live because Instagram does not allow that functionality) to the safety page of the product’s website, but the FDA has consistently shot down the supposed “one-click” rule. The problem wasn’t the medium, it was the message.

So what could Duchesnay have done differently?

Some will argue that the space constraints of social media make it nearly impossible to run a branded campaign. While it is true that there are more hurdles to branded promotion, that wasn’t a significant roadblock in this case. For starters, the FDA has released draft guidance on how manufacturers can communicate compliantly in space constrained space (namely Twitter). The underlying principle is the same as it has always been: if you include an efficacy claim you have to also include risk information. On Twitter, FDA says a callout of the most serious side effect and a link to the important safety information will suffice. That leaves you with a Tweet that looks something like this (example from the FDA): “NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure 378 disorder www.nofocus.com/risk.” Obviously, that’s not the most effective promotional content but it gives you an idea of how the FDA is thinking. On Instagram, there is a bit more real estate at your disposal. The original post from Kim was about 650 characters. Photo captions can be about 2,200 characters on Instagram. That gave the drug maker a little more than 1,700 characters to work with to communicate risk information. The ISI on Diclegis’ site is about 2,500 characters, but given the FDA’s stance on communicating safety on Twitter, it’s reasonable to assume that the agency would have accepted an abbreviated version that effectively communicated risk information. The drug maker had options to use social media to execute a branded campaign.

There are a lot of lessons to be learned from this incident. It reinforces that the FDA is monitoring social media channels. It highlights that the agency is committed to enforcing its stance on acceptable promotional materials and it confirms that it will not accept the “one-click” rule. However, this is not a lesson on the perils of social media; it’s a lesson on carefully crafting the message.

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