Latest Drugwonks' Blog
Government-Run Health Care means making referees into players. The Public Option: A Flagrant Foul
According to Evan Tracey (Campaign Media Analysis Group, a group that tracks political advertising), those opposed to the healthcare bill passed by the House (led by the U.S. Chamber of Commerce)have spent $24 million on TV commercials over the past month to $12 million spent by those who support the legislation (led by Healthcare for America Now and Moveon.org) This is a reversal from the previous spending advantage by bill supporters enjoyed through most of this year.
Why? Consider that Senate Majority Leader Harry Reid (D, NV) is drafting the Senate’s version of the bill behind closed doors.
"There's no input from any of us, no input from Republicans" said R. Bruce Josten of the U.S. Chamber of Commerce. "So what option do we have than to take our message and story to the American people?"
And the American people need to hear all sides of the argument. According to a new Associated Press poll, 43 percent of Americans oppose the health care plans being discussed in Congress, while 41 percent are in support. An additional 15 percent remain neutral or undecided.
CMPI’s Peter Pitts Talks with Pixels and Pills at the FDA Hearings
Peter Pitts Talks with Pixels and Pills at the FDA Hearings from Zemoga on Vimeo.
CMPI’s Robert Goldberg on America's Nightly Scoreboard Fox Business
Bob Goldberg on America's Nightly Scoreboard (Fox Business News) from CMPI on Vimeo.
Linda Gorman writes: “A little noticed feature of the health reform legislation is the common tendency to regulate insurance premiums in a way that will force young people to pay more so that older people can pay less. The legislation would gouge people at the time of life when their wages tend to be low in order to subsidize people at a time in their life when wages tend to be high.”
She’s absolutely right. No matter which proposal you look at in either the House or Senate, young Americans will get a raw deal.
CMPI recently interviewed Congressman Aaron Schock – the youngest member of Congress at age 28. We asked him about this issue and more.
Schock is optimistic that young Americans will come to recognize that the current proposals under consideration in Congress will lead to less choices and control for them in health care, not more.
Perhaps more importantly, Congressman Schock correctly notes the deleterious effect this legislation would have on an already precarious job market.
It amounts to a double whammy for America’s youth.
For Congressman Schock’s perspective on this issue, watch our interview with him here:
She’s absolutely right. No matter which proposal you look at in either the House or Senate, young Americans will get a raw deal.
CMPI recently interviewed Congressman Aaron Schock – the youngest member of Congress at age 28. We asked him about this issue and more.
Schock is optimistic that young Americans will come to recognize that the current proposals under consideration in Congress will lead to less choices and control for them in health care, not more.
Perhaps more importantly, Congressman Schock correctly notes the deleterious effect this legislation would have on an already precarious job market.
It amounts to a double whammy for America’s youth.
For Congressman Schock’s perspective on this issue, watch our interview with him here:
Congressman Aaron Schock (R,IL) on Health Care reform from CMPI on Vimeo.
Salon.com Liberal writer Camille Paglia on the health care bill that passed the House of Representatives:
“As for the actual content of the House healthcare bill, horrors! Where to begin? That there are serious deficiencies and injustices in the U.S. healthcare system has been obvious for decades. To bring the poor and vulnerable into the fold has been a high ideal and an urgent goal for most Democrats. But this rigid, intrusive and grotesquely expensive bill is a nightmare. Holy Hygeia, why can't my fellow Democrats see that the creation of another huge, inefficient federal bureaucracy would slow and disrupt the delivery of basic healthcare and subject us all to a labyrinthine mass of incompetent, unaccountable petty dictators? Massively expanding the number of healthcare consumers without making due provision for the production of more healthcare providers means that we're hurtling toward a staggering logjam of de facto rationing. Steel yourself for the deafening screams from the careerist professional class of limousine liberals when they get stranded for hours in the jammed, jostling anterooms of doctors' offices. They'll probably try to hire Caribbean nannies as ringers to do the waiting for them.”
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.”
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.
Many thanks to all who sent such kind comments on my FDA Part 15 testimony today. My complete remarks can be found here.
A few tidbits:
As Walter O’Malley – the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”
The Internet can be extremely useful in informing patient discussions with doctors. It can be a helpful tool to empower an individual in their medical decisions. But it is important to remember that not everything online is true. The Internet has made it easier than ever before for charlatans and quacks to spread fear and misinformation. Mark Twain wrote, “Beware of health books. You might die of a misprint.” Having a website does not replace having insight.
Regulated companies mustn’t feel safe behind a social media Maginot Line. Social media is a social movement and using the excuse that healthcare firms can’t engage because “we’re different,” misses the point. Compliance issues are very important, but it’s precisely because of the “special difference” -- the responsibility of advancing the public health -- that these companies must engage actively and creatively in social media.
As the great social media philosopher, Buffalo Springfield, opined, “There’s something happening here. And what it is ain’t exactly clear.”
One thing that healthcare companies’ worry about is that social media commentators will not factually report the news. A legitimate concern, but is this any different then accurately pitching a story to a reporter at the New York Times and having her miss or misrepresent a clinical data point?
Whether it’s the New York Times or a blog or a social media site for caregivers, information “in” is vetted and controlled. Information “out” is not. Errors and hyperbole are, for better or worse, freedoms of the press.
According to the Pew Internet and American Life Project, 113 million Americans search online for answers to their health questions. Three quarters of these individuals rarely, if ever, check the sources of the material they find
Without the participation of regulated healthcare players, the social media field is left to snake-oil salesmen, Internet drug dealers, unscrupulous trial lawyers and others who operate without almost any constraints whatsoever. Nature abhors a vacuum. It is irresponsible not to correct healthcare information errors. And yet that is precisely the advice being regularly given by regulatory consultants. It is a sad state of affairs indeed that ambiguity on behalf of the FDA has led us to this dangerous state of affairs.
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.
As F. Scott Fitzgerald wrote, “At 18 our convictions are hills from which we look; at 45 they are caves in which we hide.”
Social media is still too young an adventure for us to seek shelter in the caves of caution, complacency and compliance.
A few tidbits:
As Walter O’Malley – the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”
The Internet can be extremely useful in informing patient discussions with doctors. It can be a helpful tool to empower an individual in their medical decisions. But it is important to remember that not everything online is true. The Internet has made it easier than ever before for charlatans and quacks to spread fear and misinformation. Mark Twain wrote, “Beware of health books. You might die of a misprint.” Having a website does not replace having insight.
Regulated companies mustn’t feel safe behind a social media Maginot Line. Social media is a social movement and using the excuse that healthcare firms can’t engage because “we’re different,” misses the point. Compliance issues are very important, but it’s precisely because of the “special difference” -- the responsibility of advancing the public health -- that these companies must engage actively and creatively in social media.
As the great social media philosopher, Buffalo Springfield, opined, “There’s something happening here. And what it is ain’t exactly clear.”
One thing that healthcare companies’ worry about is that social media commentators will not factually report the news. A legitimate concern, but is this any different then accurately pitching a story to a reporter at the New York Times and having her miss or misrepresent a clinical data point?
Whether it’s the New York Times or a blog or a social media site for caregivers, information “in” is vetted and controlled. Information “out” is not. Errors and hyperbole are, for better or worse, freedoms of the press.
According to the Pew Internet and American Life Project, 113 million Americans search online for answers to their health questions. Three quarters of these individuals rarely, if ever, check the sources of the material they find
Without the participation of regulated healthcare players, the social media field is left to snake-oil salesmen, Internet drug dealers, unscrupulous trial lawyers and others who operate without almost any constraints whatsoever. Nature abhors a vacuum. It is irresponsible not to correct healthcare information errors. And yet that is precisely the advice being regularly given by regulatory consultants. It is a sad state of affairs indeed that ambiguity on behalf of the FDA has led us to this dangerous state of affairs.
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.
As F. Scott Fitzgerald wrote, “At 18 our convictions are hills from which we look; at 45 they are caves in which we hide.”
Social media is still too young an adventure for us to seek shelter in the caves of caution, complacency and compliance.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
