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Perspectives & Predictions

On The FDAs Part 15 HearingOn Social Media

NOVEMBER 16, 2009

PETER J. PITTS

PARTNER/DIRECTOR

GLOBAL HEALTH

PORTER NOVELLI


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2Perspectives & Predictions On The Fdas Part 15 Hearing On Social Media

able o Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Day One . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Day 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Appendix A: Peter J. Pitts Part 15 estimony . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Appendix B: Part 15 Hearing Speaker List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Appendix C: List o FDA Panel Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Appendix D: FDA Part 15 Hearing Federal Register Notice . . . . . . . . . . . . . . . . . . . . . . . . 20

For more inormation, please contact:

Peter Pittswitter: @PeterPitts

Email: [email protected]

Phone: (212) 601-8208

As a Porter Novelli partner and director o global health care, Peter manages the overallPorter Novelli health care team rom the New York of ce. He works with executive

teams globally and in each region to strategize the course o health care growth across

the organization, and ensures delivery o Porter Novellis value proposition to new and

existing clients. Peter also serves as president o the Center or Medicine in the Public

Interest, a think tank on public health care policy issues.


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Introduction

On September 21st the FDA announced that (on November 12th and 13th) it would hold a two-day Part 15 meeting on the

implications o the Internet and social media. Te bureaucratic-sounding title o the meeting, Promotion o Food and Drug

Administration-Regulated Medical Products Using the Internet and Social Media ools; Notice o Public Hearing,belied

both its importance and urgency.

ACCORDING TO THE AGENCYS FEDERAL REGISTER NOTICE:

Te Internet has become a widely used medium or companies, including manuacturers, packers, ordistributors o medical products regulated by FDA, to disseminate inormation about their products.

Te Internets ability to acilitate communication, inormation sharing, inormation exchange

between systems, user-centered design, and collaboration has also evolved as a result o the second

generation o Web development and Web design, or Web 2.0. Web 2.0 has led to the emergence o

a variety o social media tools (i.e., Web properties whose online content is primarily created and

published by users rather than the property owners).

Te continually evolving nature o the Internet, including Web 2.0 and social media tools, as well

as their expansion to applications such as mobile technology, have raised questions and concerns

over how to apply existing regulations to promotion in these newer media. FDA is evaluating howthe statutory provisions, regulations, and policies concerning advertising and promotional labeling

should be applied to product-related inormation on the Internet and newer technologies. Although

the agency believes that many issues can be addressed through existing FDA regulations, special

characteristics o Web 2.0 and other emerging technologies may require the agency to provide

additional guidance to the industry on how the regulations should be applied.

TO THAT END, THE FDA POSED FIVE BROAD QUESTIONS:

1 For what online communications are manuacturers, packers, or distributors accountable?

2 How can manuacturers, packers, or distributors ulfll regulatory requirements (e.g., air balance,

disclosure o indication and risk inormation, postmarketing submission requirements) in their

Internet and social media promotion, particularly when using tools that are associated with

space limitations and tools that allow or real-time communications (e.g., microblogs, mobile

technology)?

3 What parameters should apply to the posting o corrective inormation on Web sites controlled by

third parties?

4 When is the use o links appropriate?

5 Questions specifc to Internet adverse event reporting


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(For the complete questions, please see the complete FDA Federal Register Notice, attached asAppendix D.)

Te agencys announcement set o a maelstrom o interest and speculation. Within a ew days the agency received more requests to

testiy and or available seats then it could accommodate.

Tere was also conusion. Did this mean an agency guidance was orthcoming? Would the agency tip its hand during the hearing?

No. Unlike an FDA advisory committee meeting, where the agencys position is made known via inormation packets, where

questions are asked and votes taken, a Part 15 hearing is or listening and gathering purposes. No regulatory action is required ater

the meeting is over. Tis led to cynicism in some circles that the meeting would lead nowhere and was, in act, an excuse in lieu o

more serious regulatory excogitation. Tose Doubting Tomases were in or a surprise.

Te FDA designed an aggressive and robust docket o 70 presentations over two days eaturing presenters rom the worlds o public

health, communications, regulatory law, Internet technology, the blogosphere, the pharmaceutical industry, social science, and both

patient and consumer advocacy. (For a complete list o presenters, please seeAppendix B.)

Te stage was set or what was billed as the Super Bowl o Part 15 hearings.

PA R T 1 5 H E A R I N G


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DAY

1 Te Super Bowl O Part 15 Hearings

It may have been cold and blustery outside in LEnant Plaza, but inside the air was heavy in anticipation and the NSB Conerence

Center was packed or Day One o the FDAs Part 15 Hearing on Social Media. Te atmosphere was electric (or as electric as it can

be or a room ull o FDA policy wonks and I geeks).

For those o you who keep track o such things, the docket or todays hearing was ranked #1 (as in the most heavily visited) byregulations.gov.

DDMAC panjandrum om 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 stroke o 8AM, om erric brought the crowd to order,

introduced the panel and called the rst presenter. (For a complete list o the FDA panel, please seeAppendix C.)

PANEL 1

First up was Alan Coukell o 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 oered that some space-limited social media apps might not be viable

or healthcare social media usage. Alan, dont give up so easily.

Next up was the always-eervescent John Kamp (representing the 4As and the Coalition or 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

orward and set the global gold standard or social media regulations. He also wisely pointed out that the FDA should develop its

guidelines in collaboration with the FC.

Ten came Eli Lillys Michele Sharp who wisely pointed out that social media must be used to advance the public health. Bravo.

She called or guidance both o the written and executive varieties, pointing out the dangerous unintended consequences o either

too much or too little regulatory direction. She called or a series o FDA public meetings with stakeholder groups. Showing her

Indianapolis roots, she pointed out that, when it comes to both the Internet and social media, the barn door is open and its never

going to be closed.

Speaker #3 was Boston Scientics ony Blank (speaking on behal o AdvaMed). He pointed to that organizations guiding

principles or communications and also thanked his young kids or keeping him current on social media. He spoke to the issue o

net impressions and how uture FDA guidance will have to deal with the ambiguities inherent in dealing with a medium that

changes both orm and unction on a regular basis. Per user-generated content, his is analogy was that the Internet is a white wall.

Regulated industry writes on that wall and others come in aterwards to spray graf ti on it. Industry, ony pointed out, cannot be

responsible either or the street art or or cleaning it up.

I was next up on the docket. My closing comment was, Social media is still too young an adventure or us to seek shelter in the caves

o caution, complacency and compliance. (My complete testimony can be ound asAppendix A.)

Rohit Bhargava (Ogilvy 360 Digital Inuence) oered a way to determine manuacturer accountability. He called it the 3Cs Creation. Compensation. Collaboration. I theres a yes to any o these three, says Rohit, then a company is responsible or

content.


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Tere was, during the course o the day, much conversation about responsibility. So beore I continue the Day One recap heres

what the current FDA guidance says on the matter as a point o reerence:

Next up was Je Francer o PhRMA. He called or guidance to acilitate the use o social media, the same tools being used today by

both the FDA and the White House. Well Je yes we can! Maybe. He also called or risk inormation to be presented (a la FC)

via prominently displayed hyperlinks. And, o course, he discussed PhRMAs idea or some kind o FDA Good Housekeeping

Seal o Approval. Tis set the FDA panelists on edge, as they eared the agency logo would be co-opted and construed as an implied

endorsement.

Je was ollowed by John Mack (Pharma Marketing News), who shared an online survey o his readers (354 respondents). One

nding was that respondents believe that Pharma companies should all have public social media policies and that should all embrace

transparency. Cant argue with that. He also suggested a special hash tag or any industry-sponsored tweets. And he added another

voice to the industrys obvious anti-sidewiki sentiment by declaring, Mr. Google-chev tear down this sidewiki!

PANEL 2

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 air balance and adequate provision to address risk communications, the agency has the authority to

invent a similar procedure or social media and that no new legal authority is required or the agency to do so. He also pointed out,

vis--vis the issue o sponsor interest, that the agency already addresses a very similar concern in its regulation o CME.

Diana Zuckerman (National Research Center or Women & Families) 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 dont know who to trust. (ranslation - but you can trust me.) And, since using social

media is cheaper than either broadcast or print, she believes the FDA should insist that more risk inormation be provided by

Applicants should review any Internet sites sponsored by them or adverse experience inormation,

but are not responsible or reviewing any Internet sites that are not sponsored by them.

(Post-marketing Saety Reporting or Human Drug and Biological Products Including Vaccines:http://www.da.gov/cder/guidance/4177dt.pd.)

James Sandino (the Sandino Group) reminisced about social media back in the day when he

worked on Upjohns Rogaine. Tats when social media meant a 1-800 number. Tanks or

the memories. He also said that social media is a healthcare communications canary in a coal

mine. In other words, its a way to determine switly i a marketing campaign is going to

thrive or die.


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marketers then in either print or broadcast media. She also suggested that Congress impose social media user ees.

Robert Winder (VuMedia) made the point that Anonymity is a bad thing on social media. A point taken up later per the issue o

sponsored Google links.

Wayne Gattinella (WebMD) discussed how social media enhances the doctor/patient relationship and how such engagement leads

to better patient outcomes. Now youre talking.

Final speaker o Panel 2 were the three little maids rom WEGO Health (Jack Barrette, Bob Brooks and Marie Connelly) who shared

some interesting comment rom healthcare consumers who use social media social media. My avorite, It makes us eel like were

not yelling into the air. Been there. Done that.

And at long last lunch.

PANEL 3

First aternoon presenter was iany Mura (Consensus Interactive) who called or the FDA to create a Social Media Advisory

Committee. (Isnt this something that should logically all to the Risk Communications Adcomm?) She called or social media

regulation based on the our principles o speed, responsibility, reasonable eort, 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.

Ten Craig Audet (sano-aventis) shared that his employer considers itsel a healthcare company rst and a pharmaceutical company

second. rs bien! He then wisely suggested that the static elements o 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 o rst use) but that the

ensuing user-generated content be allowed to take place in real time. Hard to argue with the realities o the web.

Next was Mark Gaydos, also o s-a, but representing the Social Media Working Group (AZ, s-a, BMS, Millennium, and Amgen).

He made a ew excellent points. First was that company sites should comply with transparent terms o use, that companies should

acknowledge and appropriately respond to o-label questions, and that social media sites (such as FaceBook and Youube) with the

interactivity eatures turned o are not social media. Nice to have that moose nally on the table.

Mark was ollowed by David Zinman (Yahoo!) who commented that the FDAs 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 Saety Inormation) boxes topromotional videos since online viewers arent as likely as V viewers to watch 30 seconds or more o air balance/adequate

provision.

Next was the dynamic duo rom J&J, Philomena McArthur and Liz Forminard. Tey discussed the power o social media to

enhance health literacy and, as a result, sae use. Clearly music to the FDA panels ears. Tey also made the important point that

clicking through to more inormation (in this case, risk inormation) is accepted practice both on Internet and social media sites

and is a whole lot better than the inamous see our ad in the Saturday Evening Post. Finally, that new rules to govern social media

must be as exible as the medium itsel.

Ten came Mark Bard (Manhattan Research). People had been quoting his research all day, so it was nice to actually hear rom the

man himsel. According to Bard, physicians want pharmaceutical companies to participate online 70% to 30%. Asked the same

question, consumers arent quite so convinced (35% approve, 25% do not and 40% are unsure). Another interesting actoid is thatwhile physicians and consumers are both online in great numbers physicians are in cyberspace with greater requency (its their job)

while consumers pop in and out (based on anecdotal need).


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PANEL 4

First speaker o the ourth and nal panel was Stan Valencis (Acsys Interactive) who pointed out that 13% o Americans hospitals

have social media sites.

Ten John Mangano (comScore) shared that there are 1,700 dedicated healthcare websites in the U.S. and that 78% o condition

suerers and 56% o caregivers visit those sites.

Fard Johnmar (Envision Solutions) said, Internet searchers are like animals on the hunt. Tey go where the inormation scentis

the strongest. Pretty eral stu or an FDA hearing. I wonder what the regulatory analogy is or 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 or this)

digital content on the web has increased 876,000% rom 1999 to 2009. I wish I could say the same or my 401(k).

Te nal presenters o the day were Mary Anne Belliveau and Amy Cowan (Google). Tey presented a proposal or newly ormatted

sponsored links that includes a more inormation link and an even more robust version or products with a black box. Well see.

End o Day 1 and so to bed.

o sleep, perchance to dream o social media guidance.


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DAY

2 Friday Te Tirteenth

You know in all those slasher movies how the audience always yells, dont go in there! when the heroine starts to peer into a dark

closet? Well Day 2 o the FDAs Part 15 hearing on social media was kind o like that especially when it came to the eatured topic

o the day -- social media and adverse event generation.

As a reminder, the our criteria or an actionable adverse event are: (1) identifable patient, (2) identifable reporter, (3) specifcuse o a drug or biologic, and(4) adverse event.

During the course o the day, there were many graphics showing an ostrich with his head in the sand and another part o the anatomy

sticking up, ully exposed, in the air.

Heres what I had to say on the matter during my remarks on Day 1:

Day 2 began with Boston Scientics ony Blank (again representing AdvaMed) saying that industry expects to be held responsible

or the responsible reporting o adverse events and or user-generated content (UGC) when it is sought or/requested by a regulatedhealthcare company an important nesse. He raised the dicey issue o anonymous AE reports, ending his comments with the

question, How can we separate the wheat rom the cha? How indeed?

Next was private citizen Kim Witczak, who called or the FDA to make the MedWatch program more accessible and user-riendly

(a theme repeated during the course o the proceedings) and that proactive monitoring o social media by industry should be viewed

as a responsible act another ot-repeated theme.

Steve Findlay (Consumers Union) said that the current AERS is a glass hal ull and suggested that theres a real need or better

Adverse event generation is the real bte noire o social media. Should companies actively avoid

participation even to the degree o monitoring lest they uncover an adverse experience?

Shouldnt companies embrace social media so that adverse experiences can be ound with greater

alacrity? Shouldnt companies be rewarded or such behavior? I regulated industry wants the

FDA to be both regulator and colleague, then its not a leap o aith to imagine that the FDA

would like industry to be proactive in its search or new ways to surace adverse events.

I know o one large pharmaceutical company whose policy is not to monitor social media sites

because they dont want to unearth adverse events. Is this responsible? Is it even supportable?

I this company received a call rom a reporter and was asked i they purposely avoid social

media so as not to fnd adverse experiences, would the truth set them ree? Legally they may be in

compliance, but it wouldnt look good on Page One or sound very good in ront o a congressional

subcommittee. In compliance and in the best interest o the public health must not be mutually

exclusive propositions.


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early saety signal communications mechanisms. He proposed that a prominent and consumer-riendly AE reporting tool be a part

o all industry marketing and communications eorts (both online and otherwise). He went even urther, suggesting that similar

eorts be required o third parties who receive industry unding. He reerred to a voluntary burden, but went on to use words like

mandatory. Later on in the day, he also called or the FDA to investigate industrys use o web optimization and that FDAs

oversight o social media should be unded by user-ees.

Tis last point brings up an important issue what parts o social media can/should FDA regulate? Te FD&C Act is pretty specic

(and the First Amendment is pretty important) and (at least in my opinion) this will lead to relatively narrow agency guidance (when

it comes). Tis will surely be a crucial point o 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

uture guidance, FDA should dene what sponsor means in the context o an industry sponsored Internet or social media site.

He also observed that online ads adjacent to user-generated content shouldnt lead to an advertiser being responsible or that UGC

just as ads on television programs (particularly live ones) arent responsible or the content o the programming.

Shaleen Gupta (Semantelli Corporation) introduced a new disease state FOFDA (Fear o FDA). He opined that, per AE

reporting and social media, that we need to use technology to help go beyond the noise. Tis issue came up more than a ew times

how to address the signal-to-noise ration. (Other speakers reerred to this problem as data smog.

Je Francer (PhRMA) commented that AE reports uncovered via social media need to be addressed not via public response butthrough private communications generating some interesting questions rom the FDA panel as to how this could be done.

Rohit Bhargava (Ogilvy 360 Digital Inuence) made the point that most AEs (broadly dened) on social media are anonymous.

Tereore they are not (technically) adverse events. A statement o the obvious and a narrow view o a signicant public health

problem/opportunity.

Rick Wion (GolinHarris) shared that one such client page (with the interactivity switched on) generated only one comment out o

400 addressed could be considered a negative product experience (and not even, technically, an adverse event).

Side note: Many (i not most) o the 69 people who testied over the two-day hearing were not FDA experts, leading to somepretty wild suggestions (such as the call or an intergalactic social media taskorce) but also some new and exciting ones. It was

clear (rom both questions and body language) that the FDA panel was both unaccustomed and uncomortable being regularly

and aggressively challenged like Anna challenging the King o Siam. Is a puzzlement was oten written across the aces o the

distinguished panel.

Tis puzzlement was particularly evident in the questions posed to multiple presenters by Gerald Del Pan (FDAs Director o

the Of ce o Surveillance and Epidemiology, CDER). Dr. Del Pan seemed perplexed that presenters wanted to talk more about

Speaking o FaceBook, I believe the FDA should create a social media adverse event FaceBook

page that people can riend in order to learn more about how to report o cial adverse events

and through which the agency can push out important saety alerts and other important risk

inormation. Ater all, as Arnie Friede pointed out in his remarks, MedWatch only captures about

10% o all adverse events.


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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 Pans questions represent an appropriate understanding as to the regulatory limitations o

what the FDA can do. Tis is very important, because it will signicantly impact the range and depth o uture FDA social media

guidance. And thats a good thing.

Per the low incidence o adverse event reporting, James Allen Heywood (PatientsLikeMe) asked, Whats the value to a patient or

reporting an adverse event? Good question. Later on he made another important (and rightening) observation, Tere is no longer

an authoritative voice o authoritative inormation. Tis statement caused the FDA panel to shit uncomortably in their seats but

elicited no questions.

Diana Zuckerman (National Research Center or Women & Families) made that point that while AE reports are anecdotal and

clinical trials are scientic both are important. And shes right particularly since AEs are a valuable source o post-market early

saety signals. Finally she said that links to MedWatch should be hard to miss rather than hard to nd. Certainly.

John Mack (Pharma Marketing News) shared research showing that only 1 out o 500 AEs on social media meet all our adverse

event criteria.

Paul Roellig (Bulletin News) suggested that any orthcoming FDA regulations should be technology neutral so as not to give any

one platorm an unair advantage. Specically, he was reerring to e-mail based versus online platorms.

Daniel Palestrant (Sermo) observed that on the physician-only site, participant ability to discern hyperbole is uncanny. An

example o social medias ability to sel-correct? Maybe.

Donna Wray (GaS Advisors) cautioned industry on commenting on every social media site, citing the danger o giving crazy talk

validity. Sound advice. But crazy is certainly in the eye o the beholder.

Jonathan Richman (Dose o 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 o a much larger issue.

Fabio Gratton (Ignite Health) shared data showing that only 27% o consumer who visit a brand.com site access saety inormation.

O that 27%, 32% nd the site via a paid search, 19% access the site directly, and 10% nd the brand site via a search engine. Te

important take-away is that paid search options lead to more use o saety data. Te more direct public health point is that the FDAs

bevy o sponsored Google link NOVs (and the resulting decline in consumer clicks on them) has actually led to less consumer use

o on-line risk inormation. A dangerous unintended consequence.

Relative to industry oversight o the Internet, Robert Grammatica (Rapp) asked, o whom should manuacturers 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 o social media as a tool to enhance health literacy and suggested that

the FDA oer a kind o 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 saety inormation 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.

Te nal presentation o the day was by the Pzer duo o Freda Lewis-Hall and Cli Tumma. Tey presented research on using

social media to communicate with physicians (example: 64% o physicians have smart phone and 81% will have them by 2012).Tey ended their remarks with an appropriate end-o-hearing comment to sustain the momentum.

And so, at 5pm right on time DDMAC Director om 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 o Part 15 hearings, while a memorable accomplishment, isnt the

end. Nor is it the beginning o the end. And, no, its not even the end o the beginning. It was just the end o the day.


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Conclusions

Where will this all lead? Abrams said, We have much work to do and its too important not to do it right. Certainly. But its

not an excuse to do nothing the ear o many in the room and in the healthcare industry.

Te FDA docket closes in February. Ater that, DDMAC will review all the materials and there will be a lot o material to be

reviewed by a pretty spare DDMAC sta. Tat will take time. Ten the FDA will have to decide what i anything it want to

do. And that also will take time.So what will we see and when will we see it?

Dont hold your breath. FDA operates in FDA time (the time it takes to get it right) almost the opposite o social media time

(immediate gratication).

My prediction a guidance sometime in late 2010 or early 2011 that ocuses on three issues: (1) the range o adverse event reporting

responsibility (not a redenition o what an adverse event is), (2) ways to make MedWatch more visible (even to the degree o

mandating prominent display o a MedWatch icon on print and broadcast advertising, promotional materials and, obviously, online)

and, (3) the creation o sae harbor parameters to allow (and, hopeully, encourage) regulated industry to correct misinormation

on the Internet.

Aaron Burr said, Never do today what you can put o till tomorrow. Delay may give clearer light as to what is best to be done.

But things didnt turn out so good or Mr. Burr.

Better or the FDA to heed the words o Benjamin Franklin, You may delay, but time will not.

# # #


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APPENDIX A: Peter J. Pitts Part 15 estimony

Te role o marketing communications is to advance the bottom line and the public good and not necessarily in that order. Giving

back is an integral part o the New Normal. And there has never been a better tool to accomplish this mission than social media.

But healthcare marketing and particularly o the regulated variety is between a rock and a hard place. On the one hand,

marketers understand the importance and opportunity in social media. Its where the people are. Its where the action is. But then

there are all those pesky regulatory concerns.As Walter OMalley the man who moved the Brooklyn Dodgers to Los Angeles once commented, Te uture is just one damn

thing ater another.

While everyone else is using social media as a healthcare communications blitzkrieg, or lightening war, regulated industry is

digging in or a sitzkrieg, a sitting war.

Tis is not good news or pharma, physicians, or patients (also known as consumers). Social media is the newest arrow in the

communications quiver, but its a discipline both misunderstood and rightening to those operating in the heavily regulated world

o healthcare.

Te Internet can be extremely useul in inorming patient discussions with doctors. It can be a helpul tool to empower an individual

in their medical decisions. But it is important to remember that not everything online is true. Te Internet has made it easier thanever beore or charlatans and quacks to spread ear and misinormation. Mark wain wrote, Beware o health books. You might die

o a misprint. Having a website does not replace having insight.

Regulated companies mustnt eel sae behind a social media Maginot Line. Social media is a social movement and using the excuse

that healthcare rms cant engage because were dierent, misses the point. Compliance issues are very important, but its precisely

because o the special dierence the responsibility o advancing the public health that these companies must engage actively

and creatively in social media.

Tere are a number o key issues relative to the use o social media by regulated healthcare entities. Let me address ve:

1 USER-GENERATED CONTENT

I a consumer with no nancial relationship or corporate interest posts a comment on a social media site thats supported by a

regulated entity say a pharmaceutical company is the regulated entity responsible or the content o the comment?

User-generated content is de acto interested (otherwise there would be no content generation) but does that mean that, de jure,

it should be considered as regulated speech?

As they say, where you stand oten depends on where you sit. And i you sit in Europe, consider a new European Court o Justice

ruling that says inormation about medicines produced by independent third parties outside anycommercial or industrial activity

may constitute advertising, even though they have no connection with the products manuacturer or marketer. According to the

As the great social media philosopher, Bualo Springfeld, opined, Teres something happeninghere. And what it is aint exactly clear.


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court, even though the third party in question is acting on his own initiative and completely independently o the manuacturer

and the seller o such a medicinal product.

Tats carte blanche or an almost complete gag order on anyone who wants to discuss anything to do with medicines.

Under such a regulatory environment would letters to the editor become liable or an FDA warning letter? What about radio call-

in comments? What about reedom o speech?

2 BLOGS

What about blogs and other social media sites that accept pharmaceutical advertising? Why are social media sites that accept

advertising any dierent rom publication such as the New York imes, or the Washington Post, or theNew England Journal o

Medicine? When is interest not conict o interest?

A related issue is that o user versus property owner. Specically, websites owned and maintained by a regulated entity, but

whose online content is created exclusively by users without any nancial interest behind their participation. For example, a social

media site or people with diabetes thats created and maintained by a company that markets a diabetes medicine. What are the

responsibilities o the property owner and what do they need to prove vis--vis disinterest?

Relative to intended to promote How can this be dierentiated rom intended to share and educate? And whose job is it to

dene such dierentiation?

As Don Draper said, Im enjoying the story so ar, but I have a eeling its not going to end well.

3 SUBSTANTIVE INFLUENCE

Which leads us to the issue o substantive inuence. What rules should apply when a healthcare company wants to pitch a story

to a blog or some other social media site with an audience thats relevant to its marketing strategy?

As the agency asked in its Federal Register notice, Are there dierent considerations that should be weighed depending on the

specic social media platorm that is used or based on the intended audience? I so, what are these considerations?

One thing that healthcare companies worry about is that social media commentators will not actually report the news. A legitimate

concern, but is this any dierent then accurately pitching a story to a reporter at the New York imesand having her miss ormisrepresent a clinical data point?

Whether its theNew York imesor a blog or a social media site or caregivers, inormation in is vetted and controlled. Inormation

out is not. Errors and hyperbole are, or better or worse, reedoms o the press.

4 CORRECTIVE INFORMATION

Te FDAs Federal Register notice comments that:

companies have stated that they have not corrected what they believe is misinormation in the belie that they could be viewed

by such an action as being responsible or all the inormation on the target Web site rather than just the inormation that they postor submit.

Tis is an issue that really strikes at the heart o the matter the unintended consequences o having responsible and regulated

companies shy away rom social media even to correct erroneous inormation.

According to the Pew Internet and American Lie Project, 113 million Americans search online or answers to their health questions.

Tree quarters o these individuals rarely, i ever, check the sources o the material they nd

Without the participation o regulated healthcare players, the social media eld is let to snake-oil salesmen, Internet drug dealers,


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unscrupulous trial lawyers and others who operate without almost any constraints whatsoever. Nature abhors a vacuum. It is

irresponsible not to correct healthcare inormation errors. And yet that is precisely the advice being regularly given by regulatory

consultants. It is a sad state o aairs indeed that ambiguity on behal o the FDA has led us to this dangerous state o aairs.

5 ADVERSE EVENT REPORTING

Te real bte noire o social media adverse event generation.

Should companies actively avoid participation even to the degree o monitoring lest they uncover an adverse experience?

Shouldnt companies embrace social media so that adverse experiences can be ound with greater alacrity? Shouldnt companies be

rewarded or such behavior? I regulated industry wants the FDA to be both regulator and colleague, then its not a leap o aith to

imagine that the FDA would like industry to be proactive in its search or new ways to surace adverse events.

I know o one large pharmaceutical company whose policy is not to monitor social media sites because they dont want to unearth

adverse events. Is this responsible? Is it even supportable? I this company received a call rom a reporter and was asked i they

purposely avoid social media so as not to nd adverse experiences, would the truth set them ree? Legally they may be in compliance,

but it wouldnt look good on Page One or sound very good in ront o a congressional subcommittee. In compliance and in the

best interest o the public health must not be mutually exclusive propositions.

As F. Scott Fitzgerald wrote, At 18 our convictions are hills rom which we look; at 45 they are caves in which we hide.

Social media is still too young an adventure or us to seek shelter in the caves o caution, complacency and compliance.

Social media is communications at the speed o lie. As Marshall McLuhan wrote, At electric speed, all orms are pushed to the

limits o their potential. Tats a terric challenge, to be pushed to the limits o our potential. But are we willing to be roused and

animated by the new rontier that is social media and the nascent healthcare experience? Are we up to the challenge?

Yes we are. Yes we can.

Yes we must.


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Individual

Kim Witczak

Individual Consumer

Accelerated Medical Ventures

Zen Chu

Founder, Accelerated Medical Ventures

Acsys Interactive

Stan Valencis

President, Acsys Interactive

AdvaMed

ony Blank

Co-Chair, AdvaMed Advertising and Promotion Working

Group

American Association o Advertising Agencies/Coalition or

Healthcare Communication

John KampExecutive Director, Coalition or Healthcare Communication

Arnold I. Friede & Associates

Arnold I. Friede, Esq.

Principal, Arnold I. Friede & Associates

Bridge Worldwide/Dose o Digital

Jonathan Richman

Director o Strategic Planning, Bridge Worldwide

Blogger, Dose o Digital

Bulletin News/Custom BriengsPaul Roellig

CEO, Bulletin News/Custom Briengs

Cadient Group

Jim Walker

Director, Emerging Media, Cadient Group

Center or Medicine in the Public Interest

Peter J. Pitts

President, Center or Medicine in the Public Interest

Partner/Director, Global Healthcare, Porter Novelli

Compass Healthcare Communications

Peter Nalen

President, Compass Healthcare Communications

Maureen Miller

Account Supervisor, Compass Healthcare Communications

comScore

John Mangano

Vice President, comScore

Pharmaceutical and Healthcare Marketing Solutions eam

Lead

Consensus Interactive

iany A. Mura

Managing Partner/Director, Digital, Consensus Interactive

Consumers Union

Steven Findlay, MPH

Senior Health Policy Analyst, Consumers Union

Digitas Health

Bruce Grant

Senior Vice President/Business Strategy, Digitas Health

Eli Lilly and Company

Michele Sharp, PharmDSenior Director, US Regulatory Aairs, Eli Lilly and Company

Envision Solutions, LLC

Fard Johnmar

Founder, Envision Solutions, LLC

Euro RSCG Lie 4D

Lawrence Mickelberg

Chie Digital Of cer, Euro RSCG Lie 4D

Global Prairie Integrated Marketing

Alex VandevereDigital Strategy Lead, Global Prairie Integrated Marketing

GolinHarris

Rick Wion

Vice President o Social Media, GolinHarris

Google

Mary Ann Belliveau

Industry Director, Health, Google

Amy Cowan

Head o Industry, Health, Google

HealthCentral

Christopher M. Schroeder

Chie Executive Of cer, HealthCentral

Appendix B: Part 15 Hearing Speaker List


17/28


Heartbeat Digital

Bill Drummy

CEO, Heartbeat Digital

MK antum

Strategist, Heartbeat Digital

Ignite Health

Fabio Gratton

Co-ounder and Chie Innovation Of cer, Ignite Health

imc2 health and wellness

Hensley Evans

President, imc2 health and wellness

Integrated Media Solutions/Te Sandino Group/Caleco

Pharma Corp

James A. Sandino

Chie Marketing Strategist, Integrated Media Solutions

President and CEO, Te Sandino Group

Director, Caleco Pharma Corp

Interactive Advertising Bureau

David G. Adams

Partner, Venable, LLP

Intouch Solutions

Wendy Blackburn

Executive Vice President, Intouch Solutions

Johnson & Johnson Family o Companies

Philomena McArthur

Sr. Director Pharm. HCC Regulatory Advertising and

Promotion, Johnson & Johnson, PRD, LLC

Elizabeth Forminard

Senior Counsel, Johnson & Johnson

LehmanMillet

David A. Saggio

Director o Interactive Strategy, LehmanMillet

Manhattan Research

Mark Bard

President, Manhattan Research

McCann Healthcare Worldwide

Dr. W. John Reeves

Global Director, Digital, McCann Healthcare Worldwide

MISI Company

Kathleen Fourte

Experience Design Architect, MISI Company

Alejandra Diaz

Experience Design Architect, MISI Company

National Research Center or Women & Families

Diana Zuckerman

President, National Research Center or Women & Families

Ogilvy 360 Digital Inuence

Rohit Bhargava

Senior Vice President, Digital, Strategy & Planning Group,

Ogilvy 360 Digital Inuence

ORC Guideline, Inc.

Morris S. Whitcup, Ph.D.

Chie Research Of cer, ORC Guideline, Inc., An inoGroup

Company

PatientsLikeMe

James Allen Heywood

Co-ounder and Chairman, PatientsLikeMe

Pew Prescription Project/Te Pew Charitable rusts

Allan Coukell

Director, Pew Prescription Project/Te Pew Charitable rusts

PzerCliord Tumma

Senior Director eam Leader, Worldwide Market Analytics,

Pzer

Freda C. Lewis-Hall

Chie Medical Of cer, Pzer

Pharma Marketing News

John Mack

Publisher, Pharma Marketing News

PhRMA

Jerey K. FrancerAssistant General Counsel, PhRMA

PricewaterhouseCoopers LLC

Karla Stricker Anderson

Managing Director, Pharmaceuticals and Lie Sciences

Advisory, PricewaterhouseCoopers LLC

RAPP

Robert Grammatica

Global Chie Healthcare Of cer, RAPP

Rosetta

Jamie Peck

Healthcare Managing Partner, Rosetta

sano-aventis

Craig M. Audet

Vice President, U.S. Regulatory Aairs Marketed Products,

sano-aventis U.S.


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Semantelli Corporation

Shaleen Gupta

President, Semantelli Corporation

Sermo

Daniel Palestrant, MD

CEO and Founder, Sermo

Social Media Working Group

Mark Gaydos

Senior Director, U.S. Regulatory Aairs Marketed Products,

sano-aventis U.S.

GaS Advisors

Donna Wray

Executive Director, GaS Advisors

VeoMed

Aaron Krinsky

CEO, VeoMed

v-Fluence Interactive

Jay ByrnePresident

VuMedi, Inc.

Robert Winder

CEO, VuMedi, Inc.

W2 Group, Inc.

Larry Weber

Chairman, W2 Group, Inc.

Waterront Media Inc.

Ben Wolin

Chie Executive Of cer, Waterront Media Inc.

WCI Consulting, Ltd.

ara M. Churik

Senior Consultant, WCI Consulting, Ltd.

WebMD

Wayne Gattinella

President & CEO, WebMD Health Corp

WEGO Health

Jack Barrette

CEO, WEGO Health

Bob Brooks

Vice President, WEGO Health

Marie Connelly

Community Director, WEGO Health

Word o Mouth Marketing Association

John Bell

President o the Board o Word o Mouth Marketing

Association

Managing Director, Ogilvy Public Relations Worldwide

Melissa Davies

Healthcare ask Force at Word o Mouth Marketing

Association

Research Director, Nielsen

Yahoo!

David Zinman

Vice President and GM, Display Advertising, Yahoo!


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Tomas W. Abrams, RPh, MBA Presiding Of cer

Director

Division o Drug Marketing, Advertising, and

Communications

Of ce o Medical Policy

Center or Drug Evaluation and Research

Kathryn J. Aikin, Ph.D.

Social Science Analyst


Communications



Rachel E. Behrman, MD, MPH

Associate Director or Medical Policy


Gerald Dal Pan, MD, MHSDirector

Of ce o Surveillance and Epidemiology


Kristin Davis, JD

Deputy Director


Communications



David J. Horowitz, JDAssistant Commissioner or Policy

Of ce o Policy, Planning, and Budget

Of ce o the Commissioner

Ele Ibarra-Pratt, RN, MPH

Branch Chie

Advertising and Promotional Labeling Branch

Division o Case Management

Of ce o Compliance and Biologics Quality

Center or Biologics Evaluation and Research

Jean-Ah Kang, PharmDSpecial Assistant to the Director


Communications



Sharon Kapsch

Chie

MDR Policy Branch

Division o Post-Market Surveillance

Of ce o Surveillance and Biometrics

Center or Devices and Radiological Health

Dorothy R. McAdams, VMD

Supervisory Veterinary Medical Of cer

Of ce o Surveillance and Compliance

Center or Veterinary Medicine

Seth S. Ray

Associate Deputy Chie Counsel or Drugs and Biologics

Of ce o the Chie Counsel

Deborah Wol, JD

Regulatory Counsel

Of ce o Compliance

Center or Devices and Radiological Health

Appendix C: List o FDA Panel Members


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Appendix D: FDA Part 15 Hearing Federal Register Notice

Department O Health And Human ServicesFood and Drug Administration

[Docket No. FDA2009N0441]

Promotion o Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media ools; Notice o

Public Hearing

AGENCY

Food and Drug Administration, HHS.

ACTION

Notice o public hearing; request or comments.

SUMMARY

Te Food and Drug Administrations (FDAs) Center or Drug Evaluation and Research (CDER), in collaboration with FDAs Center

or Biologics Evaluation and Research (CBER), Center or Veterinary Medicine (CVM), and Center or Devices and Radiological

Health (CDRH), is announcing a public hearing to discuss issues related to the promotion o FDA-regulated medical products

(including prescription drugs or humans and animals, prescription biologics, and medical devices) using the Internet and social

media tools. FDA is seeking participation in the public hearing and written comments rom all interested parties, including, but

not limited to, consumers, patients, caregivers, health care proessionals, patient groups, Internet vendors, advertising agencies, and

the regulated industry. Tis meeting and the written comments are intended to help guide FDA in making policy decisions on the

promotion o human and animal prescription drugs and biologics and medical devices using the Internet and social media tools.

FDA is seeking input on a number o specic questions but is interested in any other pertinent inormation participants in the

hearing would like to share.

DATES AND TIMES

Te public hearing will be held on November 12 and 13, 2009, rom 8 a.m. to 5 p.m. each day. Submit written or electronic

registration by

close o business on October 9, 2009. Written and electronic comments will be accepted until February 28, 2010.

LOCATION

Te public hearing will be held at the National ransportation Saety Board Conerence Center, 429 LEnant Plaza, SW., Washington,

DC 20594, 2023146305; Metro: LEnant Plaza station on the yellow, green, orange, and blue lines; see: http://ntsb.gov/events/

newlocation.htm. (FDA has veried the Web site address, but FDA is not responsible or any changes to the Web site ater this

document publishes in the Federal Register.)


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ADDRESSES

Submit written registration and written comments to the Division o Dockets Management (HFA305), Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Submit electronic registration and electronic comments, identied with the docket number ound in brackets in the heading o this

document, to http://www.regulations.gov.

ranscripts o the hearing will be available or review at the Division o Dockets Management and on the Internet at

http://www.regulations.govapproximately 30 days ater the hearing (see section VI o this document).

REGISTRATION TO ATTEND AND/OR TO PARTICIPATE IN THE MEETING

Seating at the hearing is limited. People interested in attending should submit written or electronic registration as specied above (see

ADDRESSES) by close o business on October 9, 2009. Registration is ree and will be accepted on a rst-come, rst-served basis.

Written or electronic comments will be accepted until February 28, 2010.

Te procedures governing the hearing are ound in 21 CFR part 15 (see section IVo this document). I you wish to make an oral

presentation at the hearing, you must state your intention on your registration submission (see ADDRESSES). o speak, submit

your name, title, business af liation, addresses, telephone and ax numbers, and e-mail address. FDA has included questions or

comment in section III o this document. You should also identiy by number each question you wish to address in your presentation

and the approximate time requested. FDA will do its best to accommodate requests to speak. Individuals and organizations withcommon interests should consolidate or coordinate their presentations and request time or a joint presentation. FDA will determine

the amount o time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. Once FDA

noties registered participants o their scheduled times, presenters should submit to FDA two copies o each presentation to be given

(see FOR FURHER INFORMAION CONAC).

I you need special accommodations because o a disability, please inorm Jean-Ah Kang (see FOR FURHER INFORMAION

CONAC) at the time o registration.

FOR FURTHER INFORMATION CONTACT

Jean-Ah Kang, Division o Drug Marketing, Advertising, and CommunicationsCenter or Drug Evaluation and Research, Food and Drug Administration,

10903 New Hampshire Ave., Bldg. 51, rm. 3270

Silver Spring, MD, 209930002

el: 301.796.4269

Fax: 301.796.8444

E-mail:[email protected]

SUPPLEMENTARY INFORMATION

I BackgroundTe Internet has become a widely used medium or companies, including manuacturers, packers, or distributors o medical productsregulated by FDA, to disseminate inormation about their products. Te Internets ability to acilitate communication, inormation

sharing, inormation exchange between systems, user-centered design, and collaboration has also evolved as a result o the second

generation o Web development and Web design, or Web 2.0. Web 2.0 has led to the emergence o a variety o social media tools

(i.e., Web properties whose online content is primarily created and published by users rather than the property owners).

Te continually evolving nature o the Internet, including Web 2.0 and social media tools, as well as their expansion to applications

such as mobile technology, have raised questions and concerns over how to apply existing regulations to promotion in these newer


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media. FDA is evaluating how the statutory provisions, regulations, and policies concerning advertising and promotional labeling

should be applied to product-related inormation on the Internet and newer technologies. Although the agency believes that many

issues can be addressed through existing FDA regulations, special characteristics o Web 2.0 and other emerging technologies may

require the agency to provide additional guidance to the industry on how the regulations should be applied.

A Regulation o Advertising and LabelingUnder the Federal Food, Drug, and Cosmetic Act (the act), FDA has responsibility or regulating the labeling o prescription

drugs and medical devices and the advertising o prescription drugs and restricted medical devices. I an activity or material

is considered to be either advertising or labeling, it must meet certain requirements.

Under section 201(m) o the act (21 U.S.C. 321(m)), labeling is dened as all labels and other written, printed, or graphic

materials upon or accompanying an article. Te term accompanying has been broadly dened by the Supreme Court

(Kordel v. United States, 335 U.S. 345, 349350 (1948)). FDAs regulations give examples o labeling materials, including

brochures, mailing pieces, detailing pieces, calendars, price lists, letters, motion picture lms, and sound recordings

(202.1(l)(2) (21 CFR 202.1(l)(2))).

FDA regulates the labeling o all drugs and devices under its jurisdiction. Labeling must be truthul and nonmisleading

(section 502(a) o the act (21 U.S.C. 352(a))).

FDA also regulates the advertising or prescription drugs and biologics. Although the act does not dene what constitutes

an advertisement, FDA generally interprets the term to include inormation (other than labeling) that is issued by, oron behal o, a manuacturer, packer, or distributor and is intended to promote a product. Tis includes, or example,

advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through

media such as radio, television, and telephone communication systems (202.1(l)(1)). According to the act (section 502(n)),

a prescription drug is misbranded i its advertising does not include, in addition to the products established name and

quantitative composition, a true statement o inormation in brie summary relating to side eects, contraindications and

eectiveness o the advertised product. For prescription drug advertisements, FDAs implementing regulations (21 CFR

part 202) speciy that, among other things, the statutory requirement o a true statement is not satised i an advertisement

is alse or misleading with respect to side eects, contraindications or eectiveness or i it ails to reveal material acts about

consequences that may result rom the use o the drug as recommended or suggested in the advertisement (202.1(e)(5)).

Te prescription drug regulations also speciy that advertisements must present a air balance between inormation relating

to side eects and contraindications and inormation relating to eectiveness o the drug, which is achieved when thepresentation o true inormation relating to side eects and contraindications is comparable in depth and detail with the

claims or eectiveness or saety (202.1(e)(5)(ii)).

FDA similarly regulates advertising or restricted devices. A restricted device is a device that may be restricted to sale,

distribution, or use only with the written or oral authorization o a licensed practitioner, or in accordance with other

conditions i FDA determines that there cannot otherwise be reasonable assurance o its saety and eectiveness (21 U.S.C.

360j(e)). FDA also restricts devices through the approval orders granted to many class III devices (21 U.S.C. 360e(d)(1)(B)

(ii)). According to the act, a restricted device is misbranded i its advertising is alse or misleading in any particular (section

502(q) o the act), or i its advertising does not contain a brie statement o the intended uses o the device and relevant

warnings, precautions, side eects, and contraindications (section 502(r) o the act). Tere are currently no regulations

establishing specic requirements or the content and ormat o advertisements or restricted devices.

Although FDA has not comprehensively addressed when Internet promotion o prescription drugs and medical devices is

labeling versus advertising, the agency has jurisdiction over all prescription drug and biologic product promotion as well

as all restricted device advertising and all device promotional labeling when conducted by or on behal o a manuacturer,

packer, or distributor. Tere are no regulations that specically address Internet promotion separately rom the other types

o promotion discussed above, nor are there any regulations that prohibit the use o certain types o media to promote drugs

and medical devices. Although no rule has specically addressed Internet promotion, it is airly clear that some promotional

eorts are substantially similar in presentation and content to promotional materials in other media or publications. At the


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same time, FDA recognizes that the Internet possesses certain unique technological eatures and that some online tools that

may be used or promotion oer novel presentation and content eatures. Another emerging issue involves the reporting

o adverse event data because such inormation may initially be revealed using social media platorms in the context o

Internet promotion or FDA-regulated medical products.

B 1996 Meeting on Promotion o FDA-Regulated Products on the InternetOn October 16 and 17, 1996, FDA held a public meeting to discuss issues related to the promotion o FDA-regulated

medical products on the Internet (see 61 FR 48707, September 16, 1996). Te agencys objective was to receive broad

public input and to hear various points o view and opinions on Internet issues rom a discussion among interested persons.

A discussion group ormat was used and covered the ollowing topics: Investigational product inormation, chatrooms andnewsgroups, and Web site links. A transcript o the meeting is available at http://www.da.gov/AboutFDA/CentersOf ces/

CDER/ucm175775.htm.)

C New Internet ools and echnologySince the 1996 public meeting, there has been a massive expansion o new tools and technologies, such as blogs, microblogs,

podcasts, social network sites (social networks) and online communities, video sharing, widgets, and wikis, which are

dened as ollows:1,2

1 Adapted rom http://newmedia.hhs.gov/socialmedia101.html Social Media 101. Overview: Te WHA

and the WHY. Accessed on August 14, 2009.

2 Adapted rom http://www.usa.gov/webcontent/technology/other&lowbar;tech.shtml. Social Media and

Web 2.0 in Government. Accessed on August 14, 2009.

Blogs (e.g., Blogger, WordPress, ypePad): Blogs are Web sites with regular updates (in reverse chronological ordernewest

update at the top) that typically combine text, images (graphics or video), and links to other Web pages. Blogs are usually

inormal and take on the tone o a diary or journal entry. Some blogs are very personal, while others provide mainstream

news updates. Most blogs encourage dialogue by allowing their readers to leave comments.

Microblogs (e.g., witter): Microblogs are comprised o extremely short written blog posts, similar to text messages, and

provide real-time updates. witter is an example o a popular microblog service that lets users broadcast short messages up

to 140 characters long (tweets) using computers or mobile phones.

Podcasts (e.g., audio sharing): Podcasts (a blend o the terms iPod and broadcast) are audio or video les that users can

listen to or watch on computers or on a variety o portable media devices (like an iPod, Zune, and certain cell phones).

Podcasts are usually short and oten ree, and users can arrange via subscription to receive new podcasts automatically via

their computers or other media devices.

Social networks and online communities (e.g., Facebook, MySpace, LinkedIn, Friendster, Sermo): Social networks and

online communities give users opportunities to connect with or provide resources to clients, colleagues,amily, and riends

who share common interests. In many social networks, users create proles and then invite people to join as riends. Tere

are many dierent types o social networks and online communities, many o which are ree, and they range rom general

to those tailored or a specic demographic or interest area.Video sharing (e.g., Youube, Blip.tv, Vimeo): Also called a video hosting service, video sharing allows individuals to

upload video clips to an Internet Web site. Te video host will then store the video on its server and show the individual

dierent types o code to allow others to view or comment on the video.

Widgets: Supposedly short or window gadget, a widget is a graphic control on a Web page that allows the user to interact

with it in some way. Widgets can also be easily posted on multiple Web sites, have the added benet o hosting live content,

and oten take the orm o on-screen tools (clocks, event countdowns, auction-tickers, stock market tickers, ight arrival


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inormation, daily weather, etc.).

Wikis (e.g., Wikipedia, Medpedia): Te term wiki comes rom the Hawaiian word or ast. Wiki technology creates a

Web page that anyone with access can modiyquickly and easily. A wiki can be either open or closed, depending on the

preerences o the community using it. An open wiki allows anybody to make changes and view content. A closed wiki

allows only community members to make changes and view its content. Some wikis allow anyone to view content but only

members to edit the content.

As the use o social media tools on the Internet has prolierated, the agency has engaged in a act-nding process by

communicating with companies, third-party providers, trade associations, and other groups to gain a better understanding

o the nature o, and the technical aspects to, promotion o FDA- regulated medical products using these tools. FDA

appreciates the time and eort that these individuals, companies, and associations have invested in assisting the agency in

understanding the challenges and issues involved with Internet promotion using these newer Web 2.0 technologies.

II Purpose and Scope o the HearingTis hearing is intended to provide an opportunity or broad public participation and comment concerning Internet promotion

o FDA-regulated medical products, including human and animal prescription drugs and biologics and medical devices. Please

note that this hearing does not address nonprescription drug promotion. FDA is particularly interested in hearing views rom the

public as to how expanding Web 2.0 technologies may be used to promote medical products to both health care proessionals and

consumers in a truthul, nonmisleading, and balanced manner. In addition, FDA is seeking public comment on Internet adverse

event reporting.

III Issues or DiscussionQuestions have arisen regarding the application o the prescription drug and device advertising and labeling provisions, regulations,

and policies o promotion on the Internet, especially with regard to the use o emerging technologies such as blogs, microblogs,

podcasts, social networks and online communities, video sharing, widgets, and wikis. Tis section briey discusses the issues the

agency has identied as most requently raised by regulated companies and other interested parties. It should be noted that although

a question may raise a particular issue, that does not necessarily mean that the agency will issue guidance or a regulation on that issue.

Te agency invites comment at the public hearing on the general concept o Internet promotion, positive or negative; on any

aspect o Internet promotion that is o interest to the presenter; and on the topics outlined in the ollowing paragraphs. We arespecically interested in data and research on the use o social media tools in promotion, including data rom companies on their

own experiences, the extent to which health care proessionals and consumers are using and are inuenced by various social media

tools, and the impact o Internet and social media promotion on the public health.

1 For what online communications are manuacturers, packers, or distributors accountable?

FDA regulates promotion o medical products that is conducted by or on behal o a manuacturer, packer, or

distributor. In determining whether a manuacturer, packer, or distributor is accountable or a communication

about its product(s), the agency considers whether the manuacturer, packer, or distributor or anyone acting on

behal o the manuacturer, packer, or distributor, such as an ad agency, created the promotional communication.In addition, the agency considers whether the manuacturer, packer, or distributor or anyone acting on behal o

the manuacturer, packer, or distributor is inuencing or controlling the promotional activity or communication

in whole or in part.

Manuacturers, packers, and distributors may have a variety o options or how much control they exert over

activities on the Internet, regardless o whether the promotional activity occurs on company-sponsored venues

or on third-party venues. For example, in setting up a program about its product(s) through a chatroom, a

manuacturer, packer, or distributor may allow comments to be posted in real time with no editing or review


25/28


by the manuacturer, packer, or distributor; alternatively, the manuacturer, packer, or distributor may have the option o

reviewing and editing comments beore they are posted. Furthermore, the manuacturer, packer, or distributor may have

control over the length o time comments are visible. As a result, inormation may be available to a much broader audience

than originally engaged in the communication or program i the comments/entries are posted or an indenite period o

time (archived materials). Similarly, a manuacturer, packer, or distributor posting a video on a video-sharing site such a

Youube may choose whether or not to allow viewers to post comments.

In addition, various Web sites and tools can allow manuacturers, packers, or distributors to prompt others to communicate

about their products. For example, a manuacturer, packer, or distributor may ask or otherwise encourage users to post thei

own videos about its product(s) on sites such as Youube. A manuacturer, packer, or distributor may also send out packeto inormation to prominent bloggers with the aim o prompting the blogger to write about its product(s). Alternatively

a manuacturer, packer, or distributor may create an online community or patients or health care proessionals to discuss

disease states, which may prompt discussion about the manuacturers, distributors, or packers product(s). Te agency is

interested in hearing the views o the public on the ollowing topics:

What parameters or criteria should be applied to determine when third- party communications occurring on the Interne

and through social media technologies are subject to substantive inuence by companies that market products related to

the communication or discussion?

In particular, when should third-party discussions be treated as being perormed by, or on behal o, the companies that

market the product, as opposed to being perormed independent o the inuence o the companies marketing the products

How should companies disclose their involvement or inuence over discussions or material, particularly discussions or

material on third-party sites?

Are there dierent considerations that should be weighed depending on the specic social media platorm that is used o

based on the intended audience? I so, what are these considerations?

With regard to the potential or company communications to be altered by third parties, what is the experience to date

with respect to the unauthorized dissemination o modied product inormation (originally created by a company) by

noncompany users o the Internet?

2 How can manuacturers, packers, or distributors ulll regulatory requirements (e.g., air balance, disclosure o

indication and risk inormation, postmarketing submission requirements) in their Internet and social media promotion

particularly when using tools that are associated with space limitations and tools that allow or real-time communication

(e.g., microblogs, mobile technology)?

FDAs regulations require that any promotional communications that make claims about a companys product include

certain required disclosures, such as the indicated use o the product and the risks associated with the use o the product

(note that reminder promotion, which calls attention to the name o a product but does not make any representations o

suggestions about the product, is exempt rom these disclosure requirements (see 21 CFR 200.200, 201.100(), 201.105(d

(2), 202.1(e)(2)(i), 801.109(d)). Te prescription drug regulations also require that drug advertisements present a air

balance between inormation relating to risk and inormation relating to benet (202.1(e)(5)(ii)). Tey also speciy tha

risk inormation must be presented with a prominence and readability reasonably comparable to claims about drug benet

(202.1(e)(7)(viii)). Furthermore, or advertisements to be truthul and nonmisleading, they must contain risk inormationin each part as necessary to qualiy any representations and/or suggestions made in that part about the drug (202.1(e)

(3)(i)). Similarly, section 502(r) o the act requires a brie statement o intended use and relevant risk inormation or

restricted device advertising. In addition, section 201(n) o the act provides that a determination o whether produc

advertising or labeling is misleading relies in part on the extent to which labeling or advertising reveals acts material with

respect to possible consequences o the use o the products as represented in the labeling or advertising material. Except

or medical device applicants, applicants are also responsible or submitting copies o promotional materials to FDA (see

e.g., 314.81(b)(3)(i), 314.550, 314.640, 514.80(b)(5)(ii), 601.12()(4), 601.45, and 601.94 (21 CFR 314.81(b)(3)(i),


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314.550, 314.640, 514.80(b)(5)(ii), 601.12()(4), 601.45, and 601.94)).

How should product inormation be presented using various social media tools to ensure that the user has access

to a balanced presentation o both risks and benets o medical products?

Are there data to support conclusions about whether dierent types or ormats o presentations have a positive or

negative impact on the public health?

Are there proposed solutions that may help address regulatory concerns when using social media tools associated

with space limitations or tools that allow or real-time communications to present product inormation?

How should companies address the potential volume o inormation shared on various social media sites with

regard to real-time inormation that is continuously posted and regulatory requirements to submit promotional

materials to FDA as applicable (see, e.g., 314.81(b)(3)(i), 314.550, 314.640, 514.80(b)(5)(ii), 601.12()(4),

601.45, and 601.94)?

3 What parameters should apply to the posting o corrective inormation on Web sites controlled by third parties?

Some manuacturers, packers, or distributors have expressed a desire to correct what are, in their belie,

misconceptions or misinormation about their products, including unapproved uses o their products that are

being conveyed on a Web site outside their control, such as on a blog, social networking site, or a wiki Web site

(i.e., Wikipedia). Other companies have stated that they have not corrected what they believe is misinormationin the belie that they could be viewed by such an action as being responsible or all the inormation on the target

Web site rather than just the inormation that they post or submit.

Te agency is interested in any data or research on how companies have approached these issues.

Are there any parameters or criteria that could be used to determine the appropriateness o correcting

misinormation and/or scope o inormation a company can provide when trying to correct misinormation on a

Web site outside a companys control?

Should the parameters dierentiate with regard to the prominence o the third-party site (i.e., readership), its

intended audience (e.g., general public, health care proessionals, patients), its intended purpose (e.g., personal

diary, encyclopedia-type reerence), and/or the author o the inormation on the site?

4 When is the use o links appropriate?

Te Internet allows users to move easily between Web sites or sources that provide inormation on many related

topics. Under the act, companies are prohibited rom promoting approved human and animal drugs, biologics,

and medical devices or unapproved uses. However, sponsors sometimes provide links rom their branded (e.g.,

mentions a product) Web sites to other inormational sources about diseases, such as support groups, some o

which may contain inormation about unapproved disease conditions or unapproved uses o approved products.

Furthermore, some companies are using unbranded (e.g., does not mention a product) uniorm resource locators

(URLs) that, when clicked on, take users directly to branded inormation.

Te agency is interested in any comments about the appropriateness o various techniques regarding the use o

links (including between various social media tools) and data or research about whether or not users nd these

approaches to be misleading.

Should parameters be established or links to and rom Web sites?

In addition, the agency is interested in any data or research concerning the requency with which users actually

click on dierent categories o links (e.g., banner ads, links within Web sites, sponsored links, organic search result


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links) to get additional inormation about products.

5 Questions specic to Internet adverse event reporting FDA regulations require the submission o postmarketing

adverse event reports.

For drugs, adverse event reporting obligations are described or approved new drug applications (NDAs),

abbreviated new drug applications (ANDAs), and prescription drugs marketed without an approved application

under 310.305, 314.80, and 314.98 (21 CFR 310.305, 314.80, and 314.98, respectively. For new animal

drugs, adverse event reporting obligations are described or approved new animal drug applications (NADAs)and abbreviated new animal drug applications (ANADAs) under 514.80. Licensed manuacturers that hold

biological license applications (BLAs) are also subject to adverse event reporting requirements under 600.80 (21

CFR 600.80). Tese regulations cover requirements or submission o individual case saety reports on either an

expedited basis (i.e., 15-day Alert reports) or on a less requent (periodic) basis, as specied in the regulations.

Nonprescription (over-the-counter or OC) drugs marketed without an approved application also have reporting

obligations under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law

109462). Under this act, reports o serious adverse events associated with OC products must be submitted to

FDA within 15 days.

FDAs Medical Device Reporting (MDR) regulation, 21 CFR part 803, requires medical device manuacturers

to identiy and monitor signicant adverse events involving their medical devices. Te regulation requiresmanuacturers o medical devices to report device-related deaths, serious injuries, and malunctions to FDA

whenever they become aware o inormation that reasonably suggests that a reportable event occurred (i.e., one o

their devices has or may have caused or contributed to the event).

Te expectation is that entities responsible or reporting will promptly review all adverse event

inormation received or otherwise obtained, which potentially includes inormation rom the

Internet and social media tools. According to FDAs March 2001 drat guidance or industry entitled

Postmarketing Saety Reporting or Human Drug and Biological Products Including Vaccines (available at:

http://www.da.gov/downloads/Biologics&xsp0;BloodVaccines/Guidance&xsp0;Compliance&xsp0;Re

gulatory&xsp0;Inormation/Guidances/Vaccines/ucm092257.pd), adverse experience inormation that is

submitted via the Internet to an entity with postmarketing reporting obligations under 310.305, 314.80, and

600.80 should be reported to FDA i there is knowledge o the our basic elements or submission o an individual

case saety report (see section IV.B in the drat guidance). Te drat guidance also states that those entities should

review any Internet sites sponsored by them or adverse experience inormation, but are not responsible or

reviewing any Internet sites that they do not sponsor; however, i they become aware o an adverse experience on

an Internet site that they do not sponsor, they should review the adverse experience and determine i it should be

reported to FDA. For OC products, the July 2009 guidance or industry entitled Postmarketing Adverse Event

Reporting or Nonprescription Human Drug Products Marketed Without an Approved Application (available at:

http://www.da.gov/downloads/Drugs/Guidance&xsp0;Compliance&xsp0;Regulatory&x sp0;Inormation/

Guidances/ucm171672.pd) lists the Internet as an example o a means or a reporter to convey adverse event

inormation associated with an OC product to the responsible person (i.e., manuacturer, packer, or distributor

whose name *** appears on the label o an OC drug marketed in the United States without an approved

application).

With the increasing use o Web-based technology by manuacturers o FDA-regulated medical products, health

care systems, and patients, and the continual emergence o dierent types o Web-based media, FDA is interested

in hearing the views o the public on the ollowing topics related to Web-based media:

How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and

social media tools with regard to monitoring adverse event inormation about their products?


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How is adverse event inormation rom these sources being received, reviewed, and processed?

What challenges are presented in handling adverse event inormation rom these sources?

What uncertainties are there regarding what should be reported rom these sources to meet FDA adverse event

reporting obligations?

IV Notice o Hearing Under 21 CFR Part 15Te Commissioner is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). Te hearing

will be conducted by a presiding of cer, accompanied by FDA senior management rom the Of ce o the Commissioner and the

Center or Drug Evaluation and Research.

Under 15.30, the hearing is inormal, and the rules o evidence do not apply. No participant may interrupt the presentation o

another participant. Only the presiding of cer and panel members may question any person during or at the conclusion o each

presentation. Public hearings under part 15 are subject to FDAs policy and procedures or electronic media coverage o FDAs

public dministrative proceedings (part 10 (21 CFR part 10), subpart C). Under 10.205, representatives o the electronic media

may be permitted, subject to certain limitations, to videotape, lm, or otherwise record FDAs public administrative proceedings,

including presentations by participants. Te hearing will be transcribed as stipulated in 15.30(b). o the extent that the conditions

or the hearing, as described in this document, conict with any provisions set out in part 15, this document acts as a waiver o those

provisions as specied in 15.30(h).

V CommentsRegardless o attendance at the public hearing, interested persons may submit written or electronic comments to the Division

o Dockets Management (see ADDRESSES). Submit a single copy o electronic comments or two paper copies o any mailed

comments, except that individuals may submit one paper copy. Comments should be identied with the docket number ound in

brackets in the heading o this document. Received comments may be seen in the Division o Dockets Management between 9 a.m.

and 4 p.m., Monday through Friday.

VI ranscripts

Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at theDivision o Dockets Management (see ADDRESSES). A transcript will also be available in either hardcopy or on CDROM, ater

submission o a Freedom o Inormation request. Written requests are to be sent to Division o Freedom o Inormation (HFI35),

Of ce o Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 630, Rockvill

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SelasTürkiye Amplify Perspectives Predictions by Tiffany Pilgrim