In Light of FDA Draft Guidance? Keep Going


by Briana Campbell (@MsMatchGirl)

By now, youve all had time to review the FDAs draft guidance on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. And youve had time to read the multitude of responses that came after (if you didnt, Fabio Gratton has compiled many of them for you). And, as this is something weve been talking about for over two years now, youve probably been waiting for our response.

We were disappointed in Advertising Ages write up calling this Social Media “Guidelines. While this draft guidance should clear some things up for pharmaceutical companies surrounding responding to unsolicited off-label inquiries via electronic media, without being the definitive guidelines that weve been waiting for since 2009 (heads up, those are not coming anytime soon, if at all), it should be used as just that a guide. Were not lawyers (well be getting you insight from one ASAP!), but wed guess that keeping social media responses in line with these guidelines should keep pharma companies out of hot water for at least the near future.

As recently as December 2011, we posted a piece, “Shoot First, Apologize Later: Why Pharma Needs to Proceed Without Social Media Guidelines, that offered up the idea that, with a bit of thoughtfulness behind it, pharma could easily embrace social media platforms, not only for the benefit of their own brands, but the patients that are searching the social web for answers.

Companies that want to change, lead or influence need to take calculated risks and proceed even without formal guidelines. Often, a permissible approach results in delays, obstacles and stagnation. For companies waiting for permission, by the time they get it, itll be too late. Someone else will lead the pack and theyll again be reduced to playing catch up.

That doesnt mean to proceed without caution and strategic foresight, but it does mean the time to act is now not at some undetermined point in the future. Consider how the U.S. Navy has embraced social media for recruiting. Realizing that conversations are happening online, with or without guidelines, they chose to not fight it and insteadpromote social media usage throughout the ranks.

There are loads of heavily regulated industries joining in online. Why shouldnt pharma be amongst them?

In lines 338 through 351 (on page 10) of the draft guidance, the FDA lays out some of the thought behind the draft guidance release, writing that “the Internet has revolutionized communication and that it has “spawned a variety of social media tools that host online content primarily created and published by users other than the intellectual property owner or product manufacturer. Given the nature of online communities and the publics growing reliance on the social web to gather information about their personal healthcare via internet communities, web pages, social platforms and discussion groups, it makes sense that the FDA should offer some thoughts on how their already stated policies for responding to off-label inquiries (first laid out in 1982, and restated many times after) can be applied to trends in emerging electronic media. From lines 207 through 209: “This draft guidance sets forth FDAs current thinking on this topic consistent with Agencys past policy statements about responding to unsolicited requests.

Many have mentioned, and we agree, that the language, as laid out in this draft guidance, seems a bit confusing. Our friend Jonathan Richman at Dose of Digital has you covered, with a handy flow chart explaining what pharma can and cannot do in responding to these requests. Wed recommend printing it out and hanging it eye-level, for easy reference.

The internet, web sites and the social web as we know them are constantly changing, evolving and growing. This draft guidance, while maybe not the set-in-stone policy so many marketers and the pharma companies they work with so many of whom are terrified to dip a toe in the water of social media, for fear of drowning in misunderstood or mis-handled regulations and red-tape were hoping for, are a nice step forward in clarifying how pharma can respond to inquiries, public and private, via the web.

So. Next steps?

Lets keep moving. Lets keep innovating, building, growing and pushing forward as the social web continues to do the same. With an eye to this guidance, and some strategic thinking before jumping on the bandwagon, there is no reason that pharma companies cant join finance and insurance in finding out the all the good that can happen from participating in social media.

We say, listen to the conversation, develop a plan around it and go forth. Stop running scared. Be smart and youll be okay.



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