The FDA has completed a two-day Part 15 Public Hearing titled “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools”.A total of 76 presentations were heard by a packed room and large webcast audience.This phase of the public hearing will continue until February 28, 2010, which is the last day to submit public testimony.The current thinking is that guidelines could emerge as early as Summer, 2010, although no formal commitment to a timeline has been given.
The tenor of the presentations was quite clear.It is time to figure out how manufacturers can engage directly with customers online.This was a nearly unanimous theme.On the flip side, very few solutions were offered at this time.And as Tom Abrams, Director of DDMAC said, “conversations are enduring and seen by millons”, so we need to figure out how to engage in the right way.
So, out of 76 presentations, here’s a “cut through the clutter”.Part I addresses key questions discussed of importance to future guidelines.Part II reflects how the world has changed and why guidelines will need to account for these market changing developments.
#1 – If you correct information online, are you responsible for the full conversation? — Speakers made the point that companies cannot be held responsible for every comment made on every site worldwide. However, it is important for companies to be empowered to correct information on third-party sites in a conversational style and continue to monitor those sites to see if a 2nd or 3rd comment is warranted to provide further clarification.In other words, the future will be about how to monitor and engage selectively and effectively to ensure the right benefit and safety info is available online.
#2 – What is the Most Effective Way to Share Safety Information? – I don’t believe anyone is defending the current approach of mentioning side effects at the end of a TV commercial or clicking to highly detailed, hard to read information.Rather, in today’s world, we have an opportunity to display safety info online that is easier to read and navigate before the first click.The good news is that the web makes it much easier for us to create the right experience.
#3 – Current paid search ads suffer from lack of clarity and lack of conversion – data shows that when you understand upfront what is being advertised, click conversion is higher.Many of today’s ads require you to click to find out more, since the upfront ad is not clear enough.Conversion goes down.FDA was encouraged to work with companies to make it possible to have more transparency upfront.
#4 — How much identifiable criteria must be there to report an AE? – several people pointed out that the current MedWatch form for AE reporting to FDA is onerous.Others discussed how few AE’s exist online vs. the total online conversation.The conclusion is that current AE reporting mechanisms need to modernize and be simplified.We also need the guidelines to clarify what a company’s obligations are as they further engage in conversation online.
#5 – Why extending a brand’s reach is linked to extending monitoring – if companies want to reach a wider audience online, then it’s important to conduct monitoring of a wider audience online, as well.The two go together.Responsibility for monitoring widens as your reach widens.
#6 — Companies are responsible for communications they create or cause to be created – if a company has a hand in the creation of content, it’s responsible.The presentations centered more around defining this from a financial standpoint.
How the World Has Changed
As the FDA considers new guidelines, here are examples of how the marketplace has changed.
#1 – Communities self-regulate effectively – online communities look out for the best interests of the community and self-regulate.They are often the best at correcting information.One example at the Hearing was VU-MEDI, a community for 10,000 surgeons, which provides a continual review more comprehensive and quicker than a typical peer-review process on new surgical procedures.
#2 – We don’t live in a simple one-click world – people search for the information they need/want and links are a critical part of the learning process.It is normal to click horizontally for broader info or click vertically for deeper info on a given topic.We don’t control a person’s search.But, we can provide them with the most options on how and where to learn via clicks. .
#3 – Search now forms the first impression for a brand – where are your customers going for information about your brand, whether it involves benefits or safety info?
#4 – Offline/Online synergy is increasing – ComScore showed that 52% of people who see an offline campaign search online for more information.This integration is becoming standard for our customers.
#5 – The importance of peers — Customers increasingly look to peers for advice.They don’t need companies in the conversation to make a decision, but they would like companies to participate, which was clear in the surveys shown this week. Companies and brands that are part of the full conversation will build trust and will be considered relevant to decision-making.The same comment applies to the FDA.
#6 – Old-style websites are decreasingly relevant -- it is content syndication that matters, not traffic to a site. The FDA will need to adjust what they require of websites to meet the new reality of how people utilize content, so content can be more easily shared.
#7 – The importance of the “core community” – Customers will often spend their days in their core community.Think of Facebook.All the more reason why we need the ability to reach people in their communities, rather than asking them to visit our sites, which they may never do.
#8 – We can improve the reach of safety information – we can extend a brand’s safety information online simply by participating in forums, Yahoo! Answers and other parts of the web where we share approved FAQ’s and other related safety information.When you combine with a strong SEO plan and knowledge of the right keywords, a brand’s reach can be extended widely with time.
#9 – The future is not with closed communities — closed communities complicate the ability to publicly share information.They prevent the syndication of important and relevant content.Place more time on open communities when possible.
#10 – Physician and patient influence is changing – we are seeing more physicians proactively utilize the web to find patients and share information.At the same time, patients with the most influence may not be affiliated with a patient group.They will be affiliated with great content and a loyal online audience.Our customers are becoming more saavy online every day.
Overall, social media guidelines will require industry to provide innovative solutions to the FDA and for the FDA to create guidelines that can evolve with the medium, rather than place increasing constrictions on it.
All the best, Bob