Tuesday, January 10, 2012

My Pollyanna View of Recent FDA Guidance

Now that we’ve had time to digest it, the industry is bursting with reviews, opinions, analyses and unanswered questions stemming from FDA’s “Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” issued Dec. 27. I weighed in with my initial “so what” analysis on the Intouch blog last week. In case you missed it, see it here.

There are many, many more reviews and analyses out there, of which Ignite’s Fabio Gratton has done a good job of curating into one handy Storify collection of more than 45 stories from other blogs, pharma companies, law firms, agencies, trade organizations and media. Wow! Talk about an industry that was hungry for some FDA news! Even Advertising Age and the Wall Street Journal Health Blog cared enough to weigh in on the topic. AstraZeneca also quickly acknowledged the release of the guidance, applauding FDA's "attention to these changing mediums."

But some of the reviews, articles, and related tweets were veiled (and not-so-veiled) complaints that FDA wasn’t more clear and that it wasn’t really social media guidance. I agree it wasn’t direct social media guidance and that plenty of questions remain. But I also believe it was important in that FDA not only acknowledged, in written guidance, that these new media exist and deserve reference, but they also provided helpful examples involving these new media. That, as far as I know, was a first.

Maybe I’m being Pollyanna and my glass is half-full on this one. Maybe if I'd taken an antognistic view, I'd garner more blog readers. Whatever. I still maintain that what we received in this document is better than what we had before. We'll take what we can get. And I hope it’s a harbinger of more clarification to come.

In case you missed them, in a nutshell, these were my six initial takeaways from my perspective:

1. Hooray for Clarity. While no doubt some questions remain, the direction is fairly specific in terms of not only what type of information can be used in responses, but also what information should and shouldn’t be provided in both public and private forums. FDA also provides an example where the use of a link to PI is appropriate. We applaud any communication from FDA that is clear (if not concise) on direction.

2. Time to Revisit Social Media Workflows. The guidance, though draft, provides enough information at this point to revisit existing social media workflows that address responawa to off-label inquiries or comments. In most cases, off-label inquiries are already routed through the appropriate channels, but FDA now lays out guidelines on how to publicly direct the queries.

3. Offline-to-Online SOPs. Since companies have been responding in a similar manner to requests for off-label information already, the document essentially acknowledges that – as many have done with social media – adapting offline processes for online application is the right way to go.

4. Let's Still Be Human. Those familiar with social media conversation norms will groan at the prospect of providing a response in a public forum in the manner in which FDA suggests. We should further assess how companies can best communicate in the manner and tone in which FDA requires without sounding like robots. Consumers won’t necessarily always welcome a terse response that redirects them to a different channel. Pharma and med device companies should work hard to craft responses that meet the requirements but still sound human!

5. Social Media Is Still an Option. FDA did not state that a company cannot respond to requests made via the Internet or social media. Indeed, the agency acknowledged that, if done correctly, pharmaceutical companies could be in a position to further the interest of public health by doing so.

6. Policing the Internet. FDA also did not state that companies are REQUIRED to respond to off-label inquiries; it’s the company’s choice. Pharma’s responsibility for policing the entire Internet was a hot topic at the 2009 hearings. This document gives us a peek into FDA’s position .

I’ll continue to noodle it and post my thoughts here. Interested in your thoughts too … am I reading too much into it with my Pollyanna perspective?


Jason Boies said...

Hi Wendy,

Given the reactions I've read in some corners of the web, you may actually get more hits right now with this more optimistic piece.

I would think most patients can appreciate discussions surrounding their health being moved to more private channels.

Overall, I think this SHOULD give Pharma a bit more confidence as far as wading into social media conversations and touching base with people using their products.

It's progress.


Jason Boies
Radian6 Community Team

Wendy W. Blackburn said...

Thanks for your comment, Jason. The discussion is certainly something in which Radian6 has a stake. When engaging in and even just monitoring the social space, pharma fears the off-label remark. At least this provides a bit more clarity on if and how pharma should deal those comments.

Yes - its progress! Thanks for joining my Pollyanna-fest.