As I’ve mentioned before on this blog, though healthcare companies (like Johnson & Johnson) would like to take a more active role in the ongoing conversations online, most are still sitting on the sidelines. Why? Well, there are a number of reasons, but one of the biggest is that there is quite a bit of uncertainty about just what is appropriate under the current regulatory framework.
It’s all rather complicated, but in the US a lot of the uncertainty around how to engage online concerns how companies that sell highly regulated prescription medications and medical devices can do so and still meet their regulatory requirements to 1) report any side effects that people may experience while taking their products and 2) to ensure they don’t promote their products beyond what is covered in their approved product label. It may sound relatively straightforward, but the reality is that these requirements cause pause since there is no clear guidance from the regulator about what behaviors or approaches are frowned upon and which are acceptable.
This uncertainty has not gone unnoticed, and for the past two days the FDA has held a hearing on the subject. I’ve been sitting in a crowded (and increasingly hot) conference room WITHOUT WiFi watching a steady stream of presentations. It’s been an interesting series of presentations so far – and it will take a while to digest all that has been discussed.
For those unable to be at the hearing or watch the webcast, some of the presentations and testimonies made can be found over at Health Central. You can also follow the flow of information from the two-day meeting on Twitter at #FDASM. I’ve also been noticing some interesting posts on the events over the past two days from Mark Senak over at Eye on FDA.
Between suggestions for different regulatory approaches, thoughts around how technology can be used to spread information and discussions about who is responsible for what, one theme kept recurring –that through responsible engagement, companies can help address and even correct misinformation about their products online. This ultimately could help patients and physicians make informed health decisions.
Hearing this theme come up again and again made me smile. You see, when the hearing was announced, it set off a flurry of meetings and discussions with people from throughout Johnson & Johnson – from legal, regulatory, public affairs and marketing -- to determine whether we would participate in the meetings and, if so, what we would say.
Though there was a lot of back and forth, one thing was clear to us – that the Internet and social media play an enormously important role in public health and health literacy and that through responsible behaviors and actions companies can – and should – help address confusing or inaccurate information online. We wanted to advocate for flexibility in the regulatory approach to online content so that companies can participate more fully, and in so doing add their voices to the online conversation with the benefit of helping to advance health literacy by providing accurate and credible product information in real time. By speaking at the hearing, we felt we could share some of our ideas about how companies like Johnson & Johnson could engage responsibly in this space.
And so yesterday, Liz Forminard from Johnson & Johnson’s legal department and Philomena McArthur from regulatory affairs for our pharmaceuticals group, stood before the FDA’s panel and provided some thoughts on behalf of the company.
What did they say?
Well, the transcript will be captured in the docket, but I thought I’d highlight a few things they touched on:
- Companies should not be held responsible for policing the whole of the Internet.
- There should be some flexibility in regulatory approaches online, and for more opportunities to take advantage of technological resources to get people accurate, credible and current information where and when they need it.
- Having clarity in regulatory approach to social media is critical to enable participation from healthcare companies that provide a valuable source of product information
There was, of course, much more said – but I think the key to all of this will be an ongoing dialog between companies, patients and the regulator to develop workable – and flexible -- approaches that will enable companies to be part of this conversation.