With the FDA social media docket closing this Sunday (along with the Olympics--there's an analogy there somewhere) I wanted to share some excerpts from our new white paper, which summarizes the FDA hearings from HealthEd's point of view and provides an outlook for our clients and partners.
Before I do, a quick list of some other viewpoints on this very compelling topic:
You probably know that at HealthEd, our business is to deeply understand patients and help healthcare companies use that knowledge to build effective solutions, improving outcomes. In our white paper, "Clearer Paths—Stronger Burdens," we recognize that one of the key themes coming out of the FDA hearings is the changing role of the patient:
An underlying theme of many presentations during the hearings was that the historical focal point of healthcare in America—the healthcare provider—appears to be shifting. In contrast, the empowered healthcare consumer is taking form, energized by the free flow of online information and perhaps a sense of frustration with the medical establishment.
Understandably, the establishment is uneasy. When Bill Drummy of Heartbeat Digital finished a thoughtful proposal for an AE reporting system for consumers, panelist Gerald Dal Pan, MD, asked: “What’s the role of the physician in all of this?” His question remains to be answered.
We identify 5 key takeways, coming out of the hearings, that could potentially
impact digital communications in the pharma industry. Of course, nobody can really know today what the FDA will decide tomorrow, but I think it's a good exercise to help frame out the issues our clients are facing. One takeaway is quite clear to us: Pharma will not have to patrol sites like Sidewiki and Wikipedia.
Speakers both supportive and critical of the pharma industry said basically the same thing: The Web is too large and too diffuse for the FDA to require manufacturers to police the whole of it.
An example that speakers cited again and again is Sidewiki, a new Google tool that lets users who install it attach comments to any Web page as if the comments were part of the page’s content. When other Sidewiki users visit the page, all the comments appear … even those that are patently false.
To balance negative comments, webmasters are allowed to post a comment in the “first position” on Sidewiki for their pages—say, a Brand.com. However, Lilly’s Michele Sharp stated that if a pharma company were to do this, it would imply an endorsement of the Sidewiki content that followed. If a future user came along and posted off‐label information, the pharma company would be liable.
It’s a good point. We believe it’s highly unlikely a manufacturer would be held accountable for content posted by somebody else on a site (or an application) not influenced by the pharma company, such as Sidewiki or Wikipedia. The question that remains: Where will the FDA draw the line between “influenced” and “noninfluenced” Web sites?
Another takeaway: MedWatch will evolve. Right now, the current MedWatch site requires users to print out a complex form (you can download it here) to report an adverse event (AE). Users must then complete the form by hand and fax it back to the FDA. That may change in the not-so-distant future.
Perhaps the greatest weakness of a fax‐based MedWatch is its lack of portability—it can’t live as an interactive widget accepting submissions directly on a Brand.com, as proposed by John Mack of Pharma Marketing News. Clearly the FDA realizes MedWatch must change with technology. Consumers and healthcare providers can now subscribe to alerts via RSS feed or text message. And consumers can download a simple widget that displays links to the MedWatch Web site.
We believe the FDA will add forms technology to a new version of MedWatch, possibly by late summer 2011, enabling healthcare consumers to type AEs directly into the system. If the agency goes that far, it would be only a short additional jump to build syndication into MedWatch, enabling manufacturers to place a standard AE reporting widget on sites they own or next to sponsored content on sites such as WebMD and YouTube. To be sure, such a reporting system would add certain requirements to pharma’s Web launches and online sponsorship initiatives. But we believe that inserting a few simple lines of code would be a fair price for the increased certainty pharma companies would enjoy in knowing they were operating within guidelines.
In my opinion, the most controversial takeaway cited in our white paper concerns the reporting of AEs. In our view, the same FDA that pulled the plug on paid search ads lacking fair balance may be as literal in its interpretation of the federal code that governs AE collection.
The requirement for AE reporting is stated clearly in the Code of Federal Regulations, 21 CFR 314.80 (b). Manufacturers must report postmarketing AEs that are “obtained or otherwise received by the applicant from any source, foreign or domestic, including information derived from commercial marketing experience.” If the pharma industry wants to benefit from commercial marketing opportunities on the social Web—and 2 days of testimony made that abundantly clear to the FDA—it makes strong policy sense for pharma to cover its tracks there as well.
Should the FDA move in this direction, it would be hard for the industry to cry foul. A 2008 study on social media AEs, presented by Nielsen’s Melissa Davies, found that only 1 of 500 online healthcare messages (.002%) met the FDA’s 4 criteria for reporting: an identifiable patient, an identifiable reporter, a specific drug, and an adverse event.To be fair, this
percentage might increase if the FDA expanded its definition of “identifiable reporter” to include screen names with associated contact information. Davies also noted that the percentage would increase if she had searched for a specific brand name rather than reviewed a random sample of health postings.
Still, the number of AEs appeared manageable for manufacturers to track, and this may have been on the mind of the FDA’s Dal Pan when he asked Davies how long it had taken to review the 500 messages. She answered that Nielsen’s human analyzers can typically review 100 messages in a day. We believe the FDA will spend time doing the math using different scenarios and will ultimately recommend some base level of social media reporting for companies that choose to participate in the medium.
HealthEd and our clients will be watching and waiting to see what really emerges from all of the testimony and data presented to the FDA. In the meantime, if you would like to receive a copy of the white paper, please reply below or drop a note to [email protected] and I would be glad to add you to the list.
Jeff Greene
Director of Strategic Services
HealthEd
