You know in all those slasher movies how the audience always yells, “don’t go in there!” when the heroine starts to peer into a dark closet? Well Day 2 of the FDA’s Part 15 hearing on social media was kind of like that – especially when it came to the featured topic of the day -- social media and adverse event generation.
As a reminder, the four criteria for an actionable adverse event are: (1) identifiable patient, (2) identifiable reporter, (3) specific use of a drug or biologic, and (4) adverse event.
During the course of the day, there were many graphics showing an ostrich with his head in the sand and another part of the anatomy sticking up, fully exposed, in the air.
Here’s what I had to say on the matter during my remarks on Day 1:
Adverse event generation is the real bête noire of social media. Should companies actively avoid participation – even to the degree of monitoring – lest they uncover an adverse experience? Shouldn’t companies embrace social media so that adverse experiences can be found with greater alacrity? Shouldn’t companies be rewarded for such behavior? If regulated industry wants the FDA to be both regulator and colleague, then it’s not a leap of faith to imagine that the FDA would like industry to be proactive in its search for new ways to surface adverse events.
I know of one large pharmaceutical company whose policy is not to monitor social media sites because they don’t want to unearth adverse events. Is this responsible? Is it even supportable? If this company received a call from a reporter and was asked if they purposely avoid social media so as not to find adverse experiences, would the truth set them free? Legally they may be in compliance, but it wouldn’t look good on Page One or sound very good in front of a congressional subcommittee. “In compliance” and “in the best interest of the public health” must not be mutually exclusive propositions.
Day 2 began with Boston Scientific’s Tony Blank (again representing AdvaMed) saying that industry expects to be held responsible for the responsible reporting of adverse events and for user-generated content (UGC) when it is sought for/requested by a regulated healthcare company – an important finesse. He raised the dicey issue of anonymous AE reports, ending his comments with the question, “How can we separate the wheat from the chaff?” How indeed?
Next was private citizen Kim Witczak, who called for the FDA to make the MedWatch program more accessible and user-friendly (a theme repeated during the course of the proceedings) and that proactive monitoring of social media by industry should be viewed as a “responsible act” – another oft-repeated theme.
Steve Findlay (Consumer’s Union) said that the current AERS is “a glass half full” and suggested that there’s a real need for better early safety signal communications mechanisms. He proposed that a prominent and consumer-friendly AE reporting tool be a part of all industry marketing and communications efforts (both online and otherwise). He went even further, suggesting that similar efforts be required of third parties who receive industry funding. He referred to a “voluntary burden,” but went on to use words like “mandatory.” Later on in the day, he also called for the FDA to “investigate” industry’s use of web optimization – and that FDA’s oversight of social media should be funded by user-fees.
This last point brings up an important issue – what parts of social media can/should FDA regulate? The FD&C Act is pretty specific (and the First Amendment is pretty important) and (at least in my opinion) this will lead to relatively narrow agency guidance (when it comes). This will surely be a crucial point of discussion in the weeks and months ahead.
Is social media really the place patients are taking their adverse event discussions?
Chris Schroeder (HealthCentral) shared new research showing that patients experiencing an adverse event would chose to (1) call their doctor (89%), (2) share their issue on a social media site (2%), (3) contact the FDA (1%). Chris also made the point that, in future guidance, FDA should define what “sponsor” means in the context of an industry “sponsored” Internet or social media site. He also observed that online ads adjacent to user-generated content shouldn’t lead to an advertiser being responsible for that UGC – just as ads on television programs (particularly live ones) aren’t responsible for the content of the programming.
Shaleen Gupta (Semantelli Corporation) introduced a new disease state – FOFDA (“Fear of FDA”). He opined that, per AE reporting and social media, that we need to use technology to help “go beyond the noise.” This issue came up more than a few times – how to address the signal-to-noise ration. (Other speakers referred to this problem as “data smog.”
Jeff Francer (PhRMA) commented that AE reports uncovered via social media need to be addressed not via public response but through private communications --generating some interesting questions from the FDA panel as to how this could be done.
Rohit Bhargava (Ogilvy 360 Digital Influence) made the point that most AEs (broadly defined) on social media are anonymous. Therefore they are not (technically) adverse events. A statement of the obvious and a narrow view of a significant public health problem/opportunity.
Rick Wion (GolinHarris) shared that one such client page (with the interactivity switched “on”) generated only one comment out of 400 addressed could be considered a negative product experience (and not even, technically, an adverse event).
Speaking of FaceBook, I believe the FDA should create a social media adverse event FaceBook page that people can “friend” in order to learn more about how to report “official” adverse events and through which the agency can push out important safety alerts and other important risk information. After all, as Arnie Friede pointed out in his remarks, MedWatch only captures about 10% of all adverse events.
Side note: Many (if not most) of the 69 people who testified over the two-day hearing were not FDA experts, leading to some pretty wild suggestions (such as the call for an “intergalactic social media taskforce”) but also some new and exciting ones. It was clear (from both questions and body language) that the FDA panel was both unaccustomed and uncomfortable being regularly and aggressively challenged – like Anna challenging the King of Siam. “Is a puzzlement” was often written across the faces of the distinguished panel.
This “puzzlement” was particularly evident in the questions posed to multiple presenters by Gerald Del Pan (FDA’s Director of the Office of Surveillance and Epidemiology, CDER). Dr. Del Pan seemed perplexed that presenters wanted to talk more about communicating to patients than about outreach to physicians. And while that may sound narrow-minded, it needs to be understood in the appropriate regulatory context. Del Pan’s questions represent an appropriate understanding as to the regulatory limitations of what the FDA can do. This is very important, because it will significantly impact the range and depth of future FDA social media guidance. And that’s a good thing.
Per the low incidence of adverse event reporting, James Allen Heywood (PatientsLikeMe) asked, “What’s the value to a patient for reporting an adverse event?” Good question. Later on he made another important (and frightening) observation, “There is no longer an authoritative voice of authoritative information.” This statement caused the FDA panel to shift uncomfortably in their seats – but elicited no questions.
Diana Zuckerman (National Research Center for Women & Families) made that point that while AE reports are “anecdotal” and clinical trials are “scientific -- both are important. And she’s right – particularly since AEs are a valuable source of post-market early safety signals. Finally she said that links to MedWatch should be “hard to miss rather than hard to find.” Certainly.
John Mack (Pharma Marketing News) shared research showing that only 1 out of 500 AEs on social media meet all four adverse event criteria.
Paul Roellig (Bulletin News) suggested that any forthcoming FDA regulations should be “technology neutral” so as not to give any one platform an unfair advantage. Specifically, he was referring to e-mail based versus online platforms.
Daniel Palestrant (Sermo) observed that on the physician-only site, participant ability to discern hyperbole is “uncanny.” An example of social media’s ability to self-correct? Maybe.
Donna Wray (TGaS Advisors) cautioned industry on commenting on every social media site, citing “the danger of giving crazy talk validity.” Sound advice. But “crazy” is certainly in the eye of the beholder.
Jonathan Richman (Dose of Digital) commented that “Community Norms” are not the same as “Regulated Norms” – another nod to the reality (both legal and otherwise) that FDA can only hope to impact a small part of a much larger issue.
Fabio Gratton (Ignite Health) shared data showing that only 27% of consumer who visit a brand.com site access safety information. Of that 27%, 32% find the site via a paid search, 19% access the site directly, and 10% find the brand site via a search engine. The important take-away is that paid search options lead to more use of safety data. The more direct public health point is that the FDA’s bevy of sponsored Google link NOVs (and the resulting decline in consumer clicks on them) has actually led to less consumer use of on-line risk information. A dangerous unintended consequence.
Relative to industry oversight of the Internet, Robert Grammatica (Rapp) asked, “To whom should manufacturers be responsible? His answer, “to the patient.” Amen. He also mentioned that social media sites that succeed are those that are designed to do more than just sell product. Common sense but not common enough practice.
Jim Walker (Cadient Group) talked about the importance of social media as a tool to enhance health literacy and suggested that the FDA offer a kind of “X Prize” to those who can develop ways to achieve this laudable goal. Well – maybe not FDA. Secretary Sebelius – are you listening?
Wendy Blackburn (Intouch Solutions) shared research demonstrating that the more prominent safety information is on a brand.com site, the greater the “bounce” rate. (“Bounce rate” is the rate at which a visitor to a site leaves that site.) Frightening.
The final presentation of the day was by the Pfizer duo of Freda Lewis-Hall and Cliff Thumma. They presented research on using social media to communicate with physicians (example: 64% of physicians have smart phone and 81% will have them by 2012). They ended their remarks with an appropriate end-of-hearing comment to “sustain the momentum.”
And so, at 5pm – right on time – DDMAC Director Tom Abrams returned to the podium, released a big sigh and said, “Wow. We made it.”
Well, not quite yet. Not by a mile. Having held the Super Bowl of Part 15 hearings, while a memorable accomplishment, isn’t the end. Nor is it the beginning of the end. And, no, it’s not even the end of the beginning. It was just the end of the day.
CONCLUSIONS
Where will this all lead? Abrams said, “We have much work to do … and it’s too important not to do it right.” Certainly. But it’s not an excuse to do nothing – the fear of many in the room and in the healthcare industry.
The FDA docket closes in February. After that, DDMAC will review all the materials – and there will be a lot of material to be reviewed by a pretty spare DDMAC staff. That will take time. Then the FDA will have to decide what – if anything – it want to do. And that also will take time.
So what will we see and when will we see it?
Don’t hold your breath. FDA operates in FDA time (“the time it takes to get it right”) -- almost the opposite of social media time (immediate gratification).
My prediction – a guidance sometime in late 2010 or early 2011 that focuses on three issues: (1) the range of adverse event reporting responsibility (not a redefinition of what an adverse event is), (2) 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, (3) the creation of “safe harbor” parameters to allow (and, hopefully, encourage) regulated industry to correct misinformation on the Internet.
Aaron Burr said, “Never do today what you can put off till tomorrow. Delay may give clearer light as to what is best to be done.”
But things didn’t turn out so good for Mr. Burr.
Better for the FDA to heed the words of Benjamin Franklin, “You may delay, but time will not.”
As a reminder, the four criteria for an actionable adverse event are: (1) identifiable patient, (2) identifiable reporter, (3) specific use of a drug or biologic, and (4) adverse event.
During the course of the day, there were many graphics showing an ostrich with his head in the sand and another part of the anatomy sticking up, fully exposed, in the air.
Here’s what I had to say on the matter during my remarks on Day 1:
Adverse event generation is the real bête noire of social media. Should companies actively avoid participation – even to the degree of monitoring – lest they uncover an adverse experience? Shouldn’t companies embrace social media so that adverse experiences can be found with greater alacrity? Shouldn’t companies be rewarded for such behavior? If regulated industry wants the FDA to be both regulator and colleague, then it’s not a leap of faith to imagine that the FDA would like industry to be proactive in its search for new ways to surface adverse events.
I know of one large pharmaceutical company whose policy is not to monitor social media sites because they don’t want to unearth adverse events. Is this responsible? Is it even supportable? If this company received a call from a reporter and was asked if they purposely avoid social media so as not to find adverse experiences, would the truth set them free? Legally they may be in compliance, but it wouldn’t look good on Page One or sound very good in front of a congressional subcommittee. “In compliance” and “in the best interest of the public health” must not be mutually exclusive propositions.
Day 2 began with Boston Scientific’s Tony Blank (again representing AdvaMed) saying that industry expects to be held responsible for the responsible reporting of adverse events and for user-generated content (UGC) when it is sought for/requested by a regulated healthcare company – an important finesse. He raised the dicey issue of anonymous AE reports, ending his comments with the question, “How can we separate the wheat from the chaff?” How indeed?
Next was private citizen Kim Witczak, who called for the FDA to make the MedWatch program more accessible and user-friendly (a theme repeated during the course of the proceedings) and that proactive monitoring of social media by industry should be viewed as a “responsible act” – another oft-repeated theme.
Steve Findlay (Consumer’s Union) said that the current AERS is “a glass half full” and suggested that there’s a real need for better early safety signal communications mechanisms. He proposed that a prominent and consumer-friendly AE reporting tool be a part of all industry marketing and communications efforts (both online and otherwise). He went even further, suggesting that similar efforts be required of third parties who receive industry funding. He referred to a “voluntary burden,” but went on to use words like “mandatory.” Later on in the day, he also called for the FDA to “investigate” industry’s use of web optimization – and that FDA’s oversight of social media should be funded by user-fees.
This last point brings up an important issue – what parts of social media can/should FDA regulate? The FD&C Act is pretty specific (and the First Amendment is pretty important) and (at least in my opinion) this will lead to relatively narrow agency guidance (when it comes). This will surely be a crucial point of discussion in the weeks and months ahead.
Is social media really the place patients are taking their adverse event discussions?
Chris Schroeder (HealthCentral) shared new research showing that patients experiencing an adverse event would chose to (1) call their doctor (89%), (2) share their issue on a social media site (2%), (3) contact the FDA (1%). Chris also made the point that, in future guidance, FDA should define what “sponsor” means in the context of an industry “sponsored” Internet or social media site. He also observed that online ads adjacent to user-generated content shouldn’t lead to an advertiser being responsible for that UGC – just as ads on television programs (particularly live ones) aren’t responsible for the content of the programming.
Shaleen Gupta (Semantelli Corporation) introduced a new disease state – FOFDA (“Fear of FDA”). He opined that, per AE reporting and social media, that we need to use technology to help “go beyond the noise.” This issue came up more than a few times – how to address the signal-to-noise ration. (Other speakers referred to this problem as “data smog.”
Jeff Francer (PhRMA) commented that AE reports uncovered via social media need to be addressed not via public response but through private communications --generating some interesting questions from the FDA panel as to how this could be done.
Rohit Bhargava (Ogilvy 360 Digital Influence) made the point that most AEs (broadly defined) on social media are anonymous. Therefore they are not (technically) adverse events. A statement of the obvious and a narrow view of a significant public health problem/opportunity.
Rick Wion (GolinHarris) shared that one such client page (with the interactivity switched “on”) generated only one comment out of 400 addressed could be considered a negative product experience (and not even, technically, an adverse event).
Speaking of FaceBook, I believe the FDA should create a social media adverse event FaceBook page that people can “friend” in order to learn more about how to report “official” adverse events and through which the agency can push out important safety alerts and other important risk information. After all, as Arnie Friede pointed out in his remarks, MedWatch only captures about 10% of all adverse events.
Side note: Many (if not most) of the 69 people who testified over the two-day hearing were not FDA experts, leading to some pretty wild suggestions (such as the call for an “intergalactic social media taskforce”) but also some new and exciting ones. It was clear (from both questions and body language) that the FDA panel was both unaccustomed and uncomfortable being regularly and aggressively challenged – like Anna challenging the King of Siam. “Is a puzzlement” was often written across the faces of the distinguished panel.
This “puzzlement” was particularly evident in the questions posed to multiple presenters by Gerald Del Pan (FDA’s Director of the Office of Surveillance and Epidemiology, CDER). Dr. Del Pan seemed perplexed that presenters wanted to talk more about communicating to patients than about outreach to physicians. And while that may sound narrow-minded, it needs to be understood in the appropriate regulatory context. Del Pan’s questions represent an appropriate understanding as to the regulatory limitations of what the FDA can do. This is very important, because it will significantly impact the range and depth of future FDA social media guidance. And that’s a good thing.
Per the low incidence of adverse event reporting, James Allen Heywood (PatientsLikeMe) asked, “What’s the value to a patient for reporting an adverse event?” Good question. Later on he made another important (and frightening) observation, “There is no longer an authoritative voice of authoritative information.” This statement caused the FDA panel to shift uncomfortably in their seats – but elicited no questions.
Diana Zuckerman (National Research Center for Women & Families) made that point that while AE reports are “anecdotal” and clinical trials are “scientific -- both are important. And she’s right – particularly since AEs are a valuable source of post-market early safety signals. Finally she said that links to MedWatch should be “hard to miss rather than hard to find.” Certainly.
John Mack (Pharma Marketing News) shared research showing that only 1 out of 500 AEs on social media meet all four adverse event criteria.
Paul Roellig (Bulletin News) suggested that any forthcoming FDA regulations should be “technology neutral” so as not to give any one platform an unfair advantage. Specifically, he was referring to e-mail based versus online platforms.
Daniel Palestrant (Sermo) observed that on the physician-only site, participant ability to discern hyperbole is “uncanny.” An example of social media’s ability to self-correct? Maybe.
Donna Wray (TGaS Advisors) cautioned industry on commenting on every social media site, citing “the danger of giving crazy talk validity.” Sound advice. But “crazy” is certainly in the eye of the beholder.
Jonathan Richman (Dose of Digital) commented that “Community Norms” are not the same as “Regulated Norms” – another nod to the reality (both legal and otherwise) that FDA can only hope to impact a small part of a much larger issue.
Fabio Gratton (Ignite Health) shared data showing that only 27% of consumer who visit a brand.com site access safety information. Of that 27%, 32% find the site via a paid search, 19% access the site directly, and 10% find the brand site via a search engine. The important take-away is that paid search options lead to more use of safety data. The more direct public health point is that the FDA’s bevy of sponsored Google link NOVs (and the resulting decline in consumer clicks on them) has actually led to less consumer use of on-line risk information. A dangerous unintended consequence.
Relative to industry oversight of the Internet, Robert Grammatica (Rapp) asked, “To whom should manufacturers be responsible? His answer, “to the patient.” Amen. He also mentioned that social media sites that succeed are those that are designed to do more than just sell product. Common sense but not common enough practice.
Jim Walker (Cadient Group) talked about the importance of social media as a tool to enhance health literacy and suggested that the FDA offer a kind of “X Prize” to those who can develop ways to achieve this laudable goal. Well – maybe not FDA. Secretary Sebelius – are you listening?
Wendy Blackburn (Intouch Solutions) shared research demonstrating that the more prominent safety information is on a brand.com site, the greater the “bounce” rate. (“Bounce rate” is the rate at which a visitor to a site leaves that site.) Frightening.
The final presentation of the day was by the Pfizer duo of Freda Lewis-Hall and Cliff Thumma. They presented research on using social media to communicate with physicians (example: 64% of physicians have smart phone and 81% will have them by 2012). They ended their remarks with an appropriate end-of-hearing comment to “sustain the momentum.”
And so, at 5pm – right on time – DDMAC Director Tom Abrams returned to the podium, released a big sigh and said, “Wow. We made it.”
Well, not quite yet. Not by a mile. Having held the Super Bowl of Part 15 hearings, while a memorable accomplishment, isn’t the end. Nor is it the beginning of the end. And, no, it’s not even the end of the beginning. It was just the end of the day.
CONCLUSIONS
Where will this all lead? Abrams said, “We have much work to do … and it’s too important not to do it right.” Certainly. But it’s not an excuse to do nothing – the fear of many in the room and in the healthcare industry.
The FDA docket closes in February. After that, DDMAC will review all the materials – and there will be a lot of material to be reviewed by a pretty spare DDMAC staff. That will take time. Then the FDA will have to decide what – if anything – it want to do. And that also will take time.
So what will we see and when will we see it?
Don’t hold your breath. FDA operates in FDA time (“the time it takes to get it right”) -- almost the opposite of social media time (immediate gratification).
My prediction – a guidance sometime in late 2010 or early 2011 that focuses on three issues: (1) the range of adverse event reporting responsibility (not a redefinition of what an adverse event is), (2) 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, (3) the creation of “safe harbor” parameters to allow (and, hopefully, encourage) regulated industry to correct misinformation on the Internet.
Aaron Burr said, “Never do today what you can put off till tomorrow. Delay may give clearer light as to what is best to be done.”
But things didn’t turn out so good for Mr. Burr.
Better for the FDA to heed the words of Benjamin Franklin, “You may delay, but time will not.”
