FDA discusses healthcare and social media
The issue of social media and its relation to healthcare has come up time and time again in recent conversations online. It’s a highly regulated and delicate space, so getting the balance right is tough. NHS Direct has achieved this through its outreach to patients on Twitter, but is in the minority.
Earlier this month, the US Food and Drug Administration (FDA) held a two-day conference to discuss this very subject, as well as the implications of the internet and social media on health.
Representatives from public health, communications professionals, regulatory law experts, bloggers and those working within the pharmaceutical space came together to try to understand how the industry as whole can take advantage of the opportunity that social media presents.
We spoke to Peter Pitts, a partner at Porter Novelli, about the outcomes of the session and whether any practical steps had been put in place. But first, it’s important to place this session in context. It was a ‘Part 15′ hearing, which means that it was a listening session for the FDA and that the goal was to discuss rather than take action specifically.
“That being said, the agency was really surprised at the attention it received,” said Pitts. “I know that upper management at the FDA understands the importance of social media in advancing the public health. Later, the organisation will have to decide what – if anything – it wants to do. And that will also take time.”
This is a postive step forwards, even though there’s nothing concrete to measure success by just yet. Tom Abrams, director of the Division of Drug Marketing, Advertising, and Communications, said; “we have much work to do … and it’s too important not to do it right.” But as Pitts pointed out, “this is not an excuse to do nothing – the fear of many at the hearing and in the healthcare industry.”
So when exactly are things likely to come together, and what might that look like? Are guidelines the answer or will we see the FDA take the lead on rolling out something more than that in relation to MedWatch, the FDA’s online information and ‘adverse event’ (unusual reactions to medications etc.) reporting programme.
“My prediction will be guidance sometime in late 2010 or early 2011 that focuses on three issues: first, the range of adverse event reporting responsibility (not a redefinition of what an adverse event is), second, ways to make MedWatch more visible (even to the degree of mandating prominent display of a MedWatch icon on print and broadcast advertising, promotional materials and, obviously, online) and third the creation of “safe harbour” parameters to allow (and, hopefully, encourage) regulated industry to correct misinformation on the Internet.”
This is a very specific way to start integrating what people are saying about particular medical products and devices online into a well-established system. However, this might actually be what the broader industry needs to see in terms of proof of concept, and that it can be done.
“My advice for regulated healthcare companies is that the use of social media is essential for both marketing and public health initiatives. It points a new a paradigm – that healthcare companies must be in the business of advancing the public health as well as the business of selling products. Social media demands the first if it will allow the latter.”
Good sense rules need to apply, and those considering using social media must consider whether their organisation or business is making a valuable addition to public health as Pitts points out above, or whether it’s just a marketing strategy. As with any industry, if this is the case, it might not be the best move and when health is added to the equation – it’s even more risky.





