Thursday, January 5, 2012

The FDA's End-Run Around Social Media

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You've read the FDA’s new partial guidelines for pharma in social media titled "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices," right? (If you haven't, go now. We're all waiting. Try Dose of Digital or Fierce Pharma.)

Okay, so in a nutshell, if I'm reading this right, it says that pharma companies are allowed to respond to people who post in private and public internet spaces about off-label uses of their drug. But have to respond privately. Specifically, these are unsolicited requests, so you can't coordinate with your marketing company to seed the idea that Brand XYZ cured baldness. There are some other considerations, but that's the gist. (Those of you waiting for complete guidelines from the FDA should get comfortable, because if this is what we got in a year or two of discussion, you're in for a long wait.)

So, here’s what is interesting:

1) The words "liability," "expectation," or "anticipate" are nowhere in this document. The FDA is not yet ready to place the burden of having to listen to every online channel on pharma. Yet. So pharma can hang back and choose not to get involved in social if they don't want to because the FDA is not forcing them to.

2) The rules for what pharma is allowed to say seem to differ depending on whether or not the request came in public or private, despite the fact that the answer must be private. (Private requests will answer scientific questions with scientific information, public requests will pretty must stick to the label and ask the requestor talk to a healthcare professional.) Thus, the same questions asked in two different medium might get two different responses.

3) The FDA is saying while pharma can respond to all unsolicited requests about their own brands, they have to respond privately. But we all know in social media nothing stays private for very long.

Let’s walk through a scenario to see how these new rules are applied.

So I write Brand XYZ and ask them a question. The brand is now allowed to respond privately, but they, as good corporate pharma citizens, must be "truthful, non-misleading, accurate and balanced," and include standard response information. Then, I go on Twitter and ask the same question and get a different response via DM or email. This isn't much on the surface, except that the FDA has done everything to keep pharma from ever saying anything anywhere that hasn't been reviewed seven ways to Sunday. The review process is the FDA's way of getting everyone to stick to the script (because it's far cheaper to stick to the script than to try something new, and gamble on whether it survives medical, regulatory and legal reviews). To allow two different responses from pharma on the same question is new.

But since the FDA is quite clear on keeping those responses private, maybe it thinks it can control the message in the world’s most porous communication environment. Which would be silly.

So either A) the FDA is asking pharma to do nothing new (i.e. "stick to the script, kids") or the FDA is anticipating (or worse, not realizing) that every private response will quickly be copied and pasted into public forums all over the internet, thus negating the FDA's own intent of keeping off-label information private.

On one hand, the new guidelines seem to focus on solving a very narrow problem in social media. On the other, the FDA may be trying to learn how quickly these "private" messages will become public, indicating that the FDA is serious about understanding the social media environment–not just in theory, but in practice.
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