It may have been cold and blustery outside in L’Enfant Plaza, but inside the air was heavy in anticipation and the NTSB Conference Center was packed for Day One of the FDA’s Part 15 Hearing on Social Media. The atmosphere was electric (or as electric as it can be for a room full of FDA policy wonks and IT geeks).
Yes – it’s the Super Bowl of FDA Part 15 hearings.
For those of you who keep track of such things, the docket for today’s hearing was ranked #1 (as in the most heavily visited) by regulations.gov.
Woot! Woot!
DDMAC panjandrum Tom Abrams did his best not to look like a deer in the headlights. But the crowd was restless. Would he really be able to squeeze 31 presentations into a single day?
Well, when the going gets tough, the tough get going. And so, at the strike of 8AM, Tom Terrific brought the crowd to order and called the first presenter.
First up was Alan Coukell of the Pew Prescription Project. Not an auspicious beginning. He hit a sour note at the top by opining that, “Social media is the same as mass media.” Hmm. He also offered that some space-limited social media apps might not be viable for healthcare social media usage. Alan – don’t give up so easily – and work on those presentation skills.
Next up was the always effervescent John Kamp (representing the 4As and the Coalition for Healthcare Communication.) He picked up the tempo quite considerably by pointing out that the Internet is the “go-to” medium and that the FDA should step forward and set the global “gold standard” for social media regulations. He also wisely pointed out that the FDA should develop its guidelines in collaboration with the FTC.
Then came the Eli Lilly’s lovely and talented Michele Sharp who wisely pointed out that social media must be used to advance the public health. Bravo. She called for guidance both of the written and “executive” varieties, pointing out the dangerous unintended consequences of either too much or too little regulatory direction. She called for a series of FDA public meetings with stakeholder groups. Showing her Hoosier roots, she pointed out that, when it comes to both the Internet and social media, “the barn door is open and it’s never going to be closed.”
Speaker #3 was Boston Scientific’s Tony Blank (speaking on behalf of AdvaMed). He pointed to that organization’s guiding principles for communications and also thanked his young kids for keeping him current on social media. (Word.) He spoke to the issue of “net” impressions (not going there) and how future FDA guidance will have to deal with the ambiguities inherent in dealing with a medium that changes both form and function on a regular basis. His analogy was that the Internet is a “white wall.” Regulated industry writes on that wall – while others come in afterwards and spray graffiti on it. Industry, Tony pointed out, cannot be responsible either for the street art – or for cleaning it up.
Next on the docket was yours truly. It was an awesome experience. My closing comment was, “Social media is still too young an adventure for us to seek shelter in the caves of caution, complacency and compliance. My complete testimony can be found at www.drugwonks.com.
Rohit Bhargava (Ogilvy 360 Digital Influence) offered a way to determine manufacturer accountability. He called it the “3Cs” – Creation. Compensation. Collaboration. If there’s a “yes” to any of these three, says Rohit, then a company is responsible for content.
There was, during the course of the day, much conversation about “responsibility.” So before I continue the Day One recap – here’s what the current FDA guidance says on the matter as a point of reference:
“Applicants should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that are not sponsored by them.”
("Post-marketing Safety Reporting for Human Drug and Biological Products Including Vaccines:” http://www.fda.gov/cder/guidance/4177dft.pdf.)
Next up was Jeff Francer of PhRMA. He called for guidance to facilitate the use of social media, “the same tools being used today by both the FDA and the White House.” Well Jeff – yes we can! Maybe. He (a la Kamp) also called for risk information to be presented (a la FTC) via “prominently displayed” hyperlinks. And, of course, he discussed PhRMA’s idea for some kind of FDA “Good Housekeeping Seal of Approval.” This set the FDA panelists on edge.
Jeff was followed by John Mack (Pharma Marketing News). John shared an online survey of his readers (354 respondents). One finding was that Pharma companies should all have public social media policies that embrace transparency. Can’t argue with that. He also suggested a special hash tag for any industry-sponsored tweets. And he added another voice to the anti-sidewiki sentiment by declaring, “Google -- tear down this sidewiki!”
End of Panel 1.
Ensuite, ex-FDA attorney and all-around nice guy Arnie Freide. Always keen to point out regulatory precedent, Arnie argued that, since the FDA already created “fair balance and adequate provision” to address risk communications, the agency has the authority to invent a similar procedure for social media – and that no new legal authority was required for the agency to do so. There goes that excuse. He also pointed out, vis-à-vis the issue of sponsor “interest,” that the agency already addresses a very similar concern in its regulation of CME.
Then came James Sandino (the Sandino Group). He told us about social media “back in the day.” That means he worked on Upjohn’s Rogaine – when “social media” meant a 1-800 number. Thanks for the memories. He also said that social media is a healthcare communications “canary in a coal mine.” In other words, it’s a way to determine – swiftly – if a marketing campaign is going to die.
Next was David Adams (Internet Advertising Bureau) who looked like he was waiting on the reception line at the wrong wedding. His big point was that “uncertainty is bad.” Nuff said.
But it was only a momentary lull, because next on the hit parade was everyone’s favorite finger-pointing know-it-all Diana Zuckerman (National Research Center for Women & Families). And she didn’t disappoint. Her first point was to explain why there weren’t more consumer groups on the docket. “They’re too busy on the Hill working for health reform.” Then she commented (relative to the one-click rule) that “one click away is one click too many.” She then talked about how pharmaceutical companies “game” Wikipedia (although she had no evidence to cite). As she commented, “You just don’t know who to trust.” (Translation –- but you can trust me.) And, since using social media is “cheaper” than either broadcast or print, that the FDA should insist that more risk information be provided by marketers. But her best suggestion was that Congress should impose social media user fees. You just can’t make this stuff up.
Then Robert Winder (VuMedia) made the point that “Anonymity is a bad thing on social media.” A point taken up later per the issue of sponsored Google links. But more on that shortly.
Then Wayne Gattinella (WebMD) discussed how social media enhances the doctor/patient relationship and how such engagement leads to better patient outcomes. Now you’re talking.
Final speaker of Panel 2 were the three little maids from WEGO Health (Jack Barrette, Bob Brooks and Marie Connelly). They shared some interesting social media consumer comments. My favorite, “It makes us feel like we’re not yelling into the air.” Been there. Done that.
And at long last lunch.
Panel 3.
First afternoon presenter was Tiffany Mura (Consensus Interactive) who called for the FDA to create a Social Media Advisory Committee. (Isn’t this something that should logically fall to the Risk Communications Adcomm?) She called for social media regulation based on the four principles of speed, responsibility, reasonable effort, and transparency.
Next was Alex Vandevere (Global Prairie Integrated Marketing) who wondered whether we need social media guidelines or guide rails? Not sure what that means – but I like the phrase.
Then Craig Audet (sanofi-aventis) shared that his employer considers itself a healthcare company – not a pharmaceutical company. Très bien! He then wisely suggested that the static elements of social media programs developed by a pharmaceutical company (oops, excuse me, by a healthcare company) be submitted to the agency via Form 2253 (at time of first use) – but that the ensuing user-generated content be allowed to take place in real time. Hard to argue with the realities of the web.
Next was Mark Gaydos, also of s-a, but representing the Social Media Working Group (AZ, s-a, BMS, Millennium, and Amgen). He made a few excellent points. First was that company sites should comply with transparent “terms of use.” That companies should acknowledge and appropriately respond to off-label questions. And that social media sites (such as FaceBook and YouTube) with the interactivity features turned off are not social media.” Nice to have that moose finally on the table.
Mark was followed by David Zinman (Yahoo!) who also made the point that the FDA’s NOVs on sponsored links has resulted in making these ads less transparent to the user. He also discussed an idea to add drop-down ISI (Important Safety Information) boxes to promotional videos – since online viewers aren’t as likely as TV viewers to watch 30 seconds or more of fair balance/adequate provision.
Next up was David Wolin (Waterfront Media) who repeated what others had already said. Not his fault – but it was already getting pretty deep into the docket.
Next was the J&J duo from J&J, Philomena McArthur and Liz Forminard. They discussed the power of social media to enhance health literacy and, as a result, safe use. Clearly music to the FDA panel’s ears. They also made the important point that “clicking through” to information (in this case, risk information) is accepted practice both on Internet and social media sites – and is a whole lot better than the infamous “see our ad in the Saturday Evening Post.” I’m sure Norman Rockwell is turning in his grave. Finally, that new rules to govern social media must be as flexible as the medium itself. (I envisage Tom Abrams as Gumby. Pokey we already have.)
And then came Big Mark Bard (Manhattan Research). People had been quoting his research all day, so it was nice to actually hear from the man himself. A few interesting data points – physicians want pharmaceutical companies to participate online 70% to 30%. Asked the same question, consumers aren’t quite so convinced (35% approve, 25% do not and 40% are unsure). Another interesting factoid is that while physicians and consumers are both online in great numbers –physicians are on with greater frequency (it’s their job) while consumers pop in and out (based on anecdotal need).
End of Panel 3 and most of the seats are still taken.
First speaker of the fourth and final panel was Stan Valencis (Acsys Interactive) who pointed out that 13% of Americans hospitals have social media sites.
Then John Mangano (comScore) shared that there are 1,700 dedicated healthcare websites in the U.S. and that 78% of condition sufferers and 56% of caregivers visit those sites.
That was followed by Fard Johnmar (Envision Solutions) who said, “Internet searchers are like animals on the hunt. They go where the information scent is the strongest.” Pretty feral stuff for an FDA hearing. I wonder what the regulatory analogy is for marking your territory?
Rounding the clubhouse turn was Lawrence Mickelberg (Euro RSCG 4D) whose contribution to the day was this memorable soundbite, “Healthcare begins at search.” Pithy and important.
Coming down the stretch, was W. John Reeves (McCann Healthcare Worldwide) who pointed out that (are you ready for this) digital content on the web has increased 876,000% from 1999 to 2009.
The final presenters of the day were Mary Anne Belliveau and Amy Cowan (Google). They presented a proposal for newly formatted sponsored links that includes a “more information” link and an even more robust version for products with a black box. We’ll see.
And so to bed.
To sleep, perchance to dream … of social media guidance.
Yes – it’s the Super Bowl of FDA Part 15 hearings.
For those of you who keep track of such things, the docket for today’s hearing was ranked #1 (as in the most heavily visited) by regulations.gov.
Woot! Woot!
DDMAC panjandrum Tom Abrams did his best not to look like a deer in the headlights. But the crowd was restless. Would he really be able to squeeze 31 presentations into a single day?
Well, when the going gets tough, the tough get going. And so, at the strike of 8AM, Tom Terrific brought the crowd to order and called the first presenter.
First up was Alan Coukell of the Pew Prescription Project. Not an auspicious beginning. He hit a sour note at the top by opining that, “Social media is the same as mass media.” Hmm. He also offered that some space-limited social media apps might not be viable for healthcare social media usage. Alan – don’t give up so easily – and work on those presentation skills.
Next up was the always effervescent John Kamp (representing the 4As and the Coalition for Healthcare Communication.) He picked up the tempo quite considerably by pointing out that the Internet is the “go-to” medium and that the FDA should step forward and set the global “gold standard” for social media regulations. He also wisely pointed out that the FDA should develop its guidelines in collaboration with the FTC.
Then came the Eli Lilly’s lovely and talented Michele Sharp who wisely pointed out that social media must be used to advance the public health. Bravo. She called for guidance both of the written and “executive” varieties, pointing out the dangerous unintended consequences of either too much or too little regulatory direction. She called for a series of FDA public meetings with stakeholder groups. Showing her Hoosier roots, she pointed out that, when it comes to both the Internet and social media, “the barn door is open and it’s never going to be closed.”
Speaker #3 was Boston Scientific’s Tony Blank (speaking on behalf of AdvaMed). He pointed to that organization’s guiding principles for communications and also thanked his young kids for keeping him current on social media. (Word.) He spoke to the issue of “net” impressions (not going there) and how future FDA guidance will have to deal with the ambiguities inherent in dealing with a medium that changes both form and function on a regular basis. His analogy was that the Internet is a “white wall.” Regulated industry writes on that wall – while others come in afterwards and spray graffiti on it. Industry, Tony pointed out, cannot be responsible either for the street art – or for cleaning it up.
Next on the docket was yours truly. It was an awesome experience. My closing comment was, “Social media is still too young an adventure for us to seek shelter in the caves of caution, complacency and compliance. My complete testimony can be found at www.drugwonks.com.
Rohit Bhargava (Ogilvy 360 Digital Influence) offered a way to determine manufacturer accountability. He called it the “3Cs” – Creation. Compensation. Collaboration. If there’s a “yes” to any of these three, says Rohit, then a company is responsible for content.
There was, during the course of the day, much conversation about “responsibility.” So before I continue the Day One recap – here’s what the current FDA guidance says on the matter as a point of reference:
“Applicants should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that are not sponsored by them.”
("Post-marketing Safety Reporting for Human Drug and Biological Products Including Vaccines:” http://www.fda.gov/cder/guidance/4177dft.pdf.)
Next up was Jeff Francer of PhRMA. He called for guidance to facilitate the use of social media, “the same tools being used today by both the FDA and the White House.” Well Jeff – yes we can! Maybe. He (a la Kamp) also called for risk information to be presented (a la FTC) via “prominently displayed” hyperlinks. And, of course, he discussed PhRMA’s idea for some kind of FDA “Good Housekeeping Seal of Approval.” This set the FDA panelists on edge.
Jeff was followed by John Mack (Pharma Marketing News). John shared an online survey of his readers (354 respondents). One finding was that Pharma companies should all have public social media policies that embrace transparency. Can’t argue with that. He also suggested a special hash tag for any industry-sponsored tweets. And he added another voice to the anti-sidewiki sentiment by declaring, “Google -- tear down this sidewiki!”
End of Panel 1.
Ensuite, ex-FDA attorney and all-around nice guy Arnie Freide. Always keen to point out regulatory precedent, Arnie argued that, since the FDA already created “fair balance and adequate provision” to address risk communications, the agency has the authority to invent a similar procedure for social media – and that no new legal authority was required for the agency to do so. There goes that excuse. He also pointed out, vis-à-vis the issue of sponsor “interest,” that the agency already addresses a very similar concern in its regulation of CME.
Then came James Sandino (the Sandino Group). He told us about social media “back in the day.” That means he worked on Upjohn’s Rogaine – when “social media” meant a 1-800 number. Thanks for the memories. He also said that social media is a healthcare communications “canary in a coal mine.” In other words, it’s a way to determine – swiftly – if a marketing campaign is going to die.
Next was David Adams (Internet Advertising Bureau) who looked like he was waiting on the reception line at the wrong wedding. His big point was that “uncertainty is bad.” Nuff said.
But it was only a momentary lull, because next on the hit parade was everyone’s favorite finger-pointing know-it-all Diana Zuckerman (National Research Center for Women & Families). And she didn’t disappoint. Her first point was to explain why there weren’t more consumer groups on the docket. “They’re too busy on the Hill working for health reform.” Then she commented (relative to the one-click rule) that “one click away is one click too many.” She then talked about how pharmaceutical companies “game” Wikipedia (although she had no evidence to cite). As she commented, “You just don’t know who to trust.” (Translation –- but you can trust me.) And, since using social media is “cheaper” than either broadcast or print, that the FDA should insist that more risk information be provided by marketers. But her best suggestion was that Congress should impose social media user fees. You just can’t make this stuff up.
Then Robert Winder (VuMedia) made the point that “Anonymity is a bad thing on social media.” A point taken up later per the issue of sponsored Google links. But more on that shortly.
Then Wayne Gattinella (WebMD) discussed how social media enhances the doctor/patient relationship and how such engagement leads to better patient outcomes. Now you’re talking.
Final speaker of Panel 2 were the three little maids from WEGO Health (Jack Barrette, Bob Brooks and Marie Connelly). They shared some interesting social media consumer comments. My favorite, “It makes us feel like we’re not yelling into the air.” Been there. Done that.
And at long last lunch.
Panel 3.
First afternoon presenter was Tiffany Mura (Consensus Interactive) who called for the FDA to create a Social Media Advisory Committee. (Isn’t this something that should logically fall to the Risk Communications Adcomm?) She called for social media regulation based on the four principles of speed, responsibility, reasonable effort, and transparency.
Next was Alex Vandevere (Global Prairie Integrated Marketing) who wondered whether we need social media guidelines or guide rails? Not sure what that means – but I like the phrase.
Then Craig Audet (sanofi-aventis) shared that his employer considers itself a healthcare company – not a pharmaceutical company. Très bien! He then wisely suggested that the static elements of social media programs developed by a pharmaceutical company (oops, excuse me, by a healthcare company) be submitted to the agency via Form 2253 (at time of first use) – but that the ensuing user-generated content be allowed to take place in real time. Hard to argue with the realities of the web.
Next was Mark Gaydos, also of s-a, but representing the Social Media Working Group (AZ, s-a, BMS, Millennium, and Amgen). He made a few excellent points. First was that company sites should comply with transparent “terms of use.” That companies should acknowledge and appropriately respond to off-label questions. And that social media sites (such as FaceBook and YouTube) with the interactivity features turned off are not social media.” Nice to have that moose finally on the table.
Mark was followed by David Zinman (Yahoo!) who also made the point that the FDA’s NOVs on sponsored links has resulted in making these ads less transparent to the user. He also discussed an idea to add drop-down ISI (Important Safety Information) boxes to promotional videos – since online viewers aren’t as likely as TV viewers to watch 30 seconds or more of fair balance/adequate provision.
Next up was David Wolin (Waterfront Media) who repeated what others had already said. Not his fault – but it was already getting pretty deep into the docket.
Next was the J&J duo from J&J, Philomena McArthur and Liz Forminard. They discussed the power of social media to enhance health literacy and, as a result, safe use. Clearly music to the FDA panel’s ears. They also made the important point that “clicking through” to information (in this case, risk information) is accepted practice both on Internet and social media sites – and is a whole lot better than the infamous “see our ad in the Saturday Evening Post.” I’m sure Norman Rockwell is turning in his grave. Finally, that new rules to govern social media must be as flexible as the medium itself. (I envisage Tom Abrams as Gumby. Pokey we already have.)
And then came Big Mark Bard (Manhattan Research). People had been quoting his research all day, so it was nice to actually hear from the man himself. A few interesting data points – physicians want pharmaceutical companies to participate online 70% to 30%. Asked the same question, consumers aren’t quite so convinced (35% approve, 25% do not and 40% are unsure). Another interesting factoid is that while physicians and consumers are both online in great numbers –physicians are on with greater frequency (it’s their job) while consumers pop in and out (based on anecdotal need).
End of Panel 3 and most of the seats are still taken.
First speaker of the fourth and final panel was Stan Valencis (Acsys Interactive) who pointed out that 13% of Americans hospitals have social media sites.
Then John Mangano (comScore) shared that there are 1,700 dedicated healthcare websites in the U.S. and that 78% of condition sufferers and 56% of caregivers visit those sites.
That was followed by Fard Johnmar (Envision Solutions) who said, “Internet searchers are like animals on the hunt. They go where the information scent is the strongest.” Pretty feral stuff for an FDA hearing. I wonder what the regulatory analogy is for marking your territory?
Rounding the clubhouse turn was Lawrence Mickelberg (Euro RSCG 4D) whose contribution to the day was this memorable soundbite, “Healthcare begins at search.” Pithy and important.
Coming down the stretch, was W. John Reeves (McCann Healthcare Worldwide) who pointed out that (are you ready for this) digital content on the web has increased 876,000% from 1999 to 2009.
The final presenters of the day were Mary Anne Belliveau and Amy Cowan (Google). They presented a proposal for newly formatted sponsored links that includes a “more information” link and an even more robust version for products with a black box. We’ll see.
And so to bed.
To sleep, perchance to dream … of social media guidance.
