FDA social media hearing, the wrapup

November 13, 2009 – 5:14 pm by Chris

The first day of FDA’s hearing on the pharmaceutical industry’s use of social media ended well, from what I could tell. I say that because around 3 PM, my office’s external Internet connection collapsed and was down until well after the day’s proceedings ended. I had no access to the live Webcast, nor could I continue my Tweeting, or even post a summary of the day.

Fortunately for all of us, several people who presented at the meeting have shared their thoughts about the first day. Rohit Bhargava of Ogilvy 360 Digital Influence highlighted seven significant presentations from day one. Among the presentations he highlighted was one I particularly wanted to hear, from Envision Solutions’ Fard Johnmar (Mr. Johnmar’s slides are here). According to Mr. Bhargava, Mr. Johnmar had called for FDA to compel companies to use “natural language” to describe side effects. Mr. Johnmar suggests that if the industry uses more natural language, the barrier of distrust between patients and the industry could be eased. “His suggestion for the FDA to compel companies to state this information in a more meaningful way may be the one takeaway from the day that actually makes the biggest impact in building more trust for the pharmaecutical industry as a whole (a tangential, but important element of the hearings),” Mr. Bhargava says.

Mr. Bhargava also highlighted Google’s end-of-the-day presentation. “It felt something like I imagine it must feel when a rock star walks into their own backstage party,” he says. “People were ’shushing’ each other so they could all pay attention and Google proceeded to share one major point – that sponsored link advertising since the FDA sent their warning letters had resulted in less clear, less transparent, less useful and less clicked on advertising. … Google shared a model for sponsored links that seemed logical and will likely be frequently debated.”

Fleishman Hillard’s Mark Senak, who blogs at Eye on FDA, caught up with one of the Google presenters, Amy Cowan, who spoke to him about Google’s goals with the new paid search concept and whether anyone was using it. Ms. Cowan was “hopeful” that FDA would look at the data Google presented and come up with a policy that would allow for relevant, usable paid search.

Yesterday, Mr. Senak had particularly praised the testimony from Michele Sharp of Eli Lilly and Co., who told the panel that without clear social media guidelines, the company was hesitant in involving itself in social media, including monitoring sites.

Most of the presenters on day one focused over and over again on the issue of how companies should not be responsible for misinformation about their products on third-party sites (in other words, companies can’t be responsible for policing the whole Web). There was also a lot of pleading to the FDA for a policy that would differentiate between sites where companies were actually responsible for the content, and sites where they had no influence over the content whatsoever. Marc Monseau of Johnson & Johnson posted at the company’s blog, JNJ BTW, about the points in this vein presented by Liz Forminard, from J&J’s legal department, and Philomena McArthur, from the company’s regulatory affairs group, as well as summing up how J&J had reacted to the hearing news.

“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,” Mr. Monseau says. “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.”

PhRMA, the industry trade organization, proposed that FDA should create a logo that could be used online to designate “FDA regulated” information. This logo could then be put into any FDA-approved promotional piece. You can find the slides for PhRMA’s presentation here; the statements made by Jeffrey Francer, PhRMA’s assistant general counsel, can be found here. John Kamp from the Coalition for Healthcare Communications also presented along this theme, in that FDA should create a designation for “FDA regulated information.”

Personally, I foresee some problems with PhRMA’s proposal, as any logo can be easily picked up by anyone who can point a mouse and copy a JPG file (my Photoshop skills, let me show you them). And if there are people in this day and age still falling for the misspelled and illogical e-mails sent by Nigerian-style spammers, there will be others who will go onto illegal pharmacy sites, see that “FDA approved” logo, and think everything on that page is 100% true, because ITS TEH INTARWEBZ AFTER ALL. Frankly, PhRMA, the people at 4chan are laughing at you right now.

One of the best-received suggestions (at least on Twitter) given to the panel was from Zen Chu of Accelerated Medical Ventures, who said DDMAC needs to hire more people who are familiar with social media. To afford the new hires, “start charging more fees,” he said.

Not testifying, but giving her perspective of the first day of the hearings, was blogger Donna R. Cryer, AKA DCPatient. (Besides being an impassioned patient, Ms. Cryer is also the head of her own health strategy firm, it seems.)

If you couldn’t tell, a ton of advertising agencies presented at the hearings; here’s a release from Euro RSCG Life summing up the results of the study presented by Euro RSCG Life’s Larry Mickelberg, chief digital officer.

(For more presentations, wrapups of day one, and stories, including from sources such as the Wall Street Journal and Reuters, Shwen Gwee, new media lead at Vertex Pharmaceuticals and a blogger at Med 2.0, provides a nice roundup of links; additionally, Ignite’s Fabio Gratton continues to post all presentations, blog entries, and tweets at his specially created page, FDASM.com. Mr. Gratton also testified, and his data is here).

Day two of the FDA hearings focused mostly on FDA’s question about how adverse event reporting can be handled in social media. Melissa K. Davies presented research from the Word of Mouth Marketing Association and Nielsen BuzzMetrics that showed very few messages, in a sampling taken from social media forums, actually talked about adverse experiences. Although 99% of the 500 messages sampled mentioned an identifiable patient, only 3% mentioned an identifiable reporter and specific patient, and only one message had all four elements needed to make an adverse event report: an identifiable patient, an identifiable drug, an identifiable reporter, and an adverse experience.

Jonathan Richman of Bridge Worldwide (who blogs at Dose of Digital), asked whether the pharmaceutical industry should be turned into sleuths to investigate adverse event reports, and pointed out that part of the industry’s paralyzing fear about spotting adverse events online was not knowing exactly when to report them. “Should they report adverse events right that minute?” he asked. “That hour? That day? That quarter?”

Several presenters focused on how difficult FDA’s Medwatch reporting form is for consumers and patients, not only to fill out, but to find. Dr. Diana Zuckerman of the National Research Center for Women and Families made another appearance, this time calling for a Medwatch link in all pharmaceutical Web pages and online promotional pieces. “These links should be be hard to miss, not hard to find,” she says.

Dr. Zuckerman referred to the Medwatch form as “dehumanizing” and “hard for people to understand,” and suggested that FDA actually change the Medwatch name to something that would be more relevant to patients and consumers.

James Heywood of PatientsLikeMe made similar points about the Medwatch forms; he called them, “hostile,” “uncomfortable,” and “asking for information in language patients don’t understand.”

Suggestions were made on the #fdasm Twitter stream for a widget companies could use on their product sites and online ads that would allow consumers to report adverse events directly to Medwatch.

I suggest that if these ads or sites do not include this link, this could be a tipoff to consumers that the information contained in the ad or site is not legitimate. This also means FDA and PhRMA better have a massive education program to show consumers what the legitimate adverse event reporting form looks like, because I guarantee you that the spammers will see this as a choice opportunity to create their own spoof links and forms and harvest sensitive information from patients.

The last presentations of the day included Bruce Grant from Digitas Health and Wendy Blackburn from InTouch Solutions. Mr. Grant reported the results of research the agency did (marketers don’t like banner ads and consumers have poor recall of these ads; they also shied away from ads that were stuffed with risk information, because they couldn’t even tell what the drug was or what it was used to treat). Ms. Blackburn proposed a “Prescription Risk Internet Provision,” and icon or image or link that can be clicked to get risk information.

Last, but not least on the docket, was Pfizer’s Clifford Thumma and Freda Lewis-Hall, who spoke about meeting the information needs of consumers, patients, and physicians, and Pfizer’s own work with Sermo in creating an experts forum for physicians. “We’re all learning on the go,” Ms. Lewis says. “I ask that you [FDA] sustain the momentum, and continue listening to the [marketing expert, patient, and physician] voices.”

Mr. Senak had some criticism for the way FDA had handled the meeting, wondering if FDA’s transparency initiative was over. “Ironically, FDA’s DDMAC has often stated during these proceedings that there is an intense amount of interest in these proceedings,” he said. “But you wouldn’t know it if you used media presence as a yardstick. They aren’t really here and they weren’t really invited. … There is no media room. There is no WiFi. There is no media support whatsoever.”

Mr. Senak tried to get Thomas Abrams, head of DDMAC, to give him a few words about the hearing and what would happen afterward, but had no luck. “When asked by me at the beginning of the meeting for two minutes to enlighten people about next steps for the FDA after this meeting, he refused,” Mr. Senak says. “He stressed that the FDA was here for these two days to listen, not to talk.”

But the blog Pixels and Pills – a joint venture between the digital company Zemoga and the healthcare advertising agency Palio – did snag an exclusive interview with Mr. Abrams. I guess we should take what we can get, because as Mr. Senak pointed out, there was no effort made to accommodate media during the hearing; that’s why I was listening to the hearing via the FDA’s streaming Webcast and not actually in the hall. (CNBC’s Mike Huckman told me that after he called FDA out yesterday, he got a voicemail offering him an interview with another FDA official).

Mr. Abrams’ final remarks did not leave attendants hopeful that there will be any guidance from the agency anytime in the near future.

(You can expect more followups to the hearing in this blog next week.)