The much anticipated public hearing on promotion of FDA-regulated medical products using the Internet and social media tools is now history and part of the record books.

69 speakers put forth more than 77 presentations and, when all was said and done, 5 key takeaways emerged. Roska Digital has developed a point-of-view article that summarizes what was said, the FDA’s reaction, what we think will change and what we think won’t.

A decent part of the afternoon sounded more like sales pitches than anything else, which is a shame given we might not get this opportunity again for...another 10 years?

It's been a long 2 days, so we'll keep this one short and not only provide takeaways, but also a couple of great quotes.

Best quote of the day goes to Jamie Peck at Rosetta:
"The Plavix site has been hijacked through Sidewiki!"

Funny, but true. Unauthorized content, off-label comments, you name it..and FDA should send Google a warning letter!

Truest quote of the day goes to Hensley Evans:
"Today was more of a monologue than a dialogue"

Not funny, but true. Without a 'conversation' how will things ever change? Here's a thought...remove any redundancy, cut the presentations down by 75%, and spend 2 days generating conversations that form a catalyst for change.

Now for some interesting data.

Digitas Health
Performed research with 1,000 users testing various display ad formats for benefit and risk recall. Scoring was based on a 4 point scale (0= no recall, 4 = 100% recall).

• 0.78/4 score for present-day ad format
• 1.94/4 score for 50/50 split between benefit and risk
• 1.94/4 score for 65/35 (benefit/risk), but higher consumer preference to this format
• 2.03/4 and highest consumer preference through combined benefit+contextually-relevant risk

• ISI requires some college education
• PI requires post-graduate level education

Seinfeld said it best, "yada, yada, yada." Most safety presentations were again more of the same.

Three main points came across loud and clear this morning:

1. Encourage restraint by FDA (give industry time to work with you and experiment)
2. Allow innovation to take root (innovation and technology can solve a lot of the problems with safety concerns)
3. Take the first step and begin to establish new guidelines
   

• We will never know (presently) true identities of individuals (nicknames, 'handles' and other present fields make it impossible to know if you are truly who you say you are
  
• Don't try to sleuth the Internet. If you can't identify the patient, they do not meet the criteria. Evaluate to what degree you feel you need to responsibly engage.
• Consider tools like iGuard (available on ConsumerMedSafety.org) for patients to enter their medications, check for possible drug interactions, and post comments and questions within one system so reports can be easily followed.

Accelerated Medical Ventures
Patients who are not engaged to not comply. Over 50% of non-compliant patients actually choose to be non compliant for one of 3 reasons:

• They feel they do not need the medication
• They fear having side effects and avoid taking the medication
• Medication simply costs too much

1. FDA should exercise restraint. Don't be so quick to issue warning letters. Open dialogue and discuss things before wielding the pen and paper too quick.
2. DDMAC should provide guidelines for pre- and post-script marketing. Meaning the safety message to patient before they fill their first script should be different than once they are on drug.
3. FDA needs to establish a new media and technology advisory board.
4. FDA needs a dedicated team and strategy for electronic/social media marketing regulations
5. Guidance needs to be more frequent (more than every 10 years!)

As you would expect, this morning has been filled with discussion about how we marketers and companies are not responsible for reporting any AEs that do not fit the 4 identifiable criteria that presently exist.

But what about going beyond hiding behind the 4 criteria and actually trying to improve the process?

A few companies had some interesting perspectives and suggestions.

PhRMA

• Per FDA ICH E2D companies are not responsible for monitoring ADRs on external sites
• Monitor your own sites and those for which you have control (without control, your ability to manage AEs is impossible)
• Companies should not have to report AEs posted in public forums

PhRMA Suggestion: Companies could, however, inject into the conversation with a statement and link suggesting poster click as they might be experiencing and AE.

Ogilvy 360

• Company should report AEs that fit all 4 criteria (wherever they are), without required follow up (could breach patient privacy)

FDA Questions to Ogilvy 360:

• How do you suggest we interact with these online communities?
• Where do HCPs and their sites fit into this (nobody has talked about HCPs this morning)?

Ogilvy 360 Answers:

• Monitoring needs to be standardized so that FDA [and companies] can interact with these communities. We need to establish consistent, reproducible standards for online reporting.
• HCPs are knowledgeable enough and educated such that they can take responsibility for their own dialogues in SM spaces. Plus, they are already overtaxed with too much paperwork and process.

Heartbeat Digital

• Burying the ISI at the bottom of the page with link to MedWatch looks like they are hiding, plus it is NOT an effective method of showing interest in safety
• 1 out of 1,000 (HealthCentral data) patients surveyed said they would actually use MedWatch

Heartbeat Digital Suggestions:

• Radcially simplify ISIs - they are too confusing for consumers
• Have companies inject into the conversations when message appears to have serious negative health implications, with link and contact info on how to report the situation
• Make it easier for patients to file an AE (MedWatch is too complex)

PatientsLikeMe

• Create an integrated pharmacogivilance form for insertion into all patient online experiences
• Fast, easy way for 2-way conversation (MedWatch is only 1-way)

FDA Questions:

• How can such a system work when many patients are on therapies with complex drug regimens?
• Any ideas on how to apply this system to medical devices?

PatientsLikeMe Answers:

• It would be possible to chart a system of all symptoms, drug interactions and compute likelihood that patient may be experiencing and AE and which drug is responsible (WOW..that is out there. Great idea, but is it doable? See below)
• PIs need to be standardized so that our software can collect the data and compute in real time. Presently this does not exist
• No system is presently in place for medical devices, however, the industry and PatientsLikeMe need to address this.

Conclusions from this morning:
While the FDA is asking lots of questions, and lots of great ideas like the above are being offered by companies and marketers, FDA is not engaging in making any suggestions or direction. Sorry to say this everyone, but it looks like we are right where we started.

For now, we have to police ourselves, form our own guidelines, use good judgement and demonstrate intent and best effort to help keep patients safe.

Day 1 of the hearings is over and I think we are hearing loud and clear the position from pharma, the industry, and the agencies.

But what about FDA?

FDA has asked a few good questions, but not explored any in detail. In my opinion, I believe this is because the presenters did not have the data at their fingertips to further the conversation.

Remember, FDA is science and data driven. Period.

I encourage all presenters who FDA probed to follow up with additional data to do so before the 30-day cut-off. This is our chance to really USE this meeting for the benefit of patients, caregivers, HCPs and really open up new opportunities for how health care is provided in the US. After all, isn't this a major charter of Obama and the White House?

Ideas shared in the last few presentations.
Everything from framework layouts and wireframes (we all got it, but FDA seemed to start to nod off) to more data and reinforcement of the 1-click rule seemed to dominate the late afternoon.

A few different key points from 2 presentations did stand out:

Google.

1. The recent FDA warning letters actually are confusing consumers (evidenced by decreased CTR and bounce rates) I talked about this a little in a past blog.
2. These same warning letters create less transparency (opposite of intended effect).

McCann Healthcare

1. Watch the trends and stay current FDA. It's our best chance at improving health care and patient literacy.
2. Provide regular guidance (not every 10 years)
3. Define social media guidelines now. Get us started...just like you did with print and TV.
4. Allow sites to pull content from FDA's own website (what more credible content can you get than that?)

And with that...Day 1 has come to a conclusion. Rather than boil the ocean and be repetitive, Day 2 summaries will focus on new information and we'll leave the repetition to the transcripts.

See you in the morning.

The resounding theme today is "transparency." Pharma and agencies alike are proposing and preaching it, now will industry uphold its own recommendations? And, if most do, will the select few renegades spoil all of the effort and ideas to date. THAT is left to be seen.

If you've been over on the twitter feed today you've seen a lot of repetition of the same points. So, for the blog, I'll try and focus on new items and information that gets everyone thinking about new possibilities (or obstacles we may have to overcome).

Change in format for this one...quick hit bullets...

Sanofi Aventis

• Suggests company owned or sponsored websites should have clear terms and check boxes that users MUST check to confirm they understand what they can and cannot do
• Terms MUST advise that UGC and discussion is for branded indication only and off-label comments/discussion will be removed
• Suggests that site alerts be placed with links so users can appropriately report AEs or problems

Yahoo!

• Primarily a sales pitch (sorry Yahoo! but it's true)
• Lobbied that rich media, with ISI scrolls satisfy present criteria (which I agree with)
• Presently testing clickable logos and video embedded into paid search results

FDA Question: Are you testing technology feasibility? Or consumer learning?

Answer: Yahoo! is testing user "interaction". (Face it. They sell ads. But now they will have the data to project learning based on clicks).

Johnson & Johnson

• Great presentation
• Social media communicates/connects people where and when they are
• Responsibility differs based on who is talking, what they are saying, and where they are posting
• Companies are not responsible for the entire Internet (love that!)
• Also not responsible for content superimposed over their content without permission
• Digital media is here to stay. We want to engage online responsibly

FDA Question: How do you suggest companies ensure the immediacy of the Internet does not adversely affect the consumer's ability to easily access the PI and safety information? And, What can FDA do to encourage consumer behavior (Hello? We'd all kill to get asked part 2 to this question).

Answer: Use scrolling ISI and 1-click rule to link to the PI and safety information. And for part two, FDA should keep doing what its doing. Hold more hearings and meetings.

I don't know about you, but part 2 of FDA's question to J&J was the perfect opportunity to ACTUALLY provide guidance and tell FDA what they can do to help us. This was a missed golden opportunity.

J&J put so many excellent stakes in the ground in their presentation...all the things we want to say, but shiver at actually saying them at the hearing...only to end on a whimper. Sorry, but it's true.

Headed back downstairs for the last session of the day.

Much more discussion evolved during the late morning sessions. I'd like to highlight two presentations, one from WebMD and one from WEGO Health.

WebMD
WebMD's position is true. Web 2.0 (when done correctly) offers an effective method by which we can inform consumers of accurate information, enabling them to take control of their health -- or at least play a more active role in it -- and enhance their dialogue with their doctors. Period.

Let's face it. Virtually all doctors are online. And, virtually all consumers are online. It is CRAZY that we are severely limited in our ability to provide platforms by which to connect them, and each other.

WebMD's CEO put it best "credible information improves [doctor] to patient interaction and improves health outcomes."

Further, "75% of doctors recommend websites to their patients as they leave the office."

Question: What information do we (and FDA) want them to have access to? The right information? Or unregulated information that might not be safe (hello? can anyone say guidelines?)

WebMD Suggestions:

• Add a "Report Abuse" button or link wherever possible in social spaces so that if someone is being irresponsible, they can be reported to the company (and FDA) and follow-up corrections can be made. It helps in monitoring and correcting inaccurate information.
• Prominently display a link to FDA's MedWatch site to enable consumers to properly report adverse events. All parties will get better results and we can stop trying to evaluate what is and is not a reportable event.

FDA Questions:

1. What about pharma reps participating in conversations? (this is no different than a hallway discussion with a doctor. Make them follow the same practices they do now. If they get caught violating protocol, consequences are severe)
2. How many people click the MedWatch adverse event tool? (WebMD to get back to FDA with data)
3. Does data exist to support that consumers truly understand links? (WebMD responds that links ARE the Internet. It is common. Do not need data)
4. Can WebMD provide data on links clicked on their site, and where users clicked to -- to build support for this assumption? (WebMD to provide follow-up data)

WEGO Health

WEGO is comprised of content contributing health activists. Chances are the top bloggers and content contributors you want to talk about your product can be found there. WEGO asserted the position that they are disappointed companies are not involved in the conversations, would "welcome them at the table" and came out and said the FDA is scaring them away from the conversation.

The issue around correction of information was a heated topic. WEGO activists absolutely want pharma to police the web and correct as many incorrect statements as possible. With a tone of realism, they also stated that it is too expensive, with too many resources required, to reach that lofty goal.

Their Conclusion (and that of the morning): Take a step. "Best effort" is all we are asking for.

The first morning session is over. Lots of repetition, lots of presentations, very little time for FDA to ask questions or process the information. However, the discussion has begun. So what were the big "Ah Ha!" moments this morning? A few nuggets did emerge.

PhRMA offered up an interesting suggestion.
Establish an FDA universal symbol and disclaimer link language that can be used in paid search advertising. This would allow consumers and HCPs to identify credible sites and posts that adhere to new guidelines. Dumbing it down, think of it as a AAA or consumer reports rating. At least consumers and HCPs know the sites are adhering to published guidelines and doing their best to provide credible, valuable information.

John Mack had an incredible idea of FDA-issued hashtags.
Hashtags are used in Twitter and they are unique. FDA could issue unique product-specific hastags that marketers must embed into their Twitter feeds so FDA can easily monitor and evaluate the adherence of these microblog posts. John gets the award for best idea of the morning!

Eli Lilly expressed its reluctance to get into the space without clearer direction from FDA.
Consistent with all of pharma, Eli Lilly expressed concerns about getting into the space without guidelines. FDA dictates what you can't do, but nothing about what you CAN do. With the flurry of FDA warning letters this year around paid search advertising, nobody wants to receive a warning letter.

Conclusion: "We have significantly avoided social media because of a lack of FDA guidance...fear of warning letters". Further, Eli Lilly cited Google's Sidewiki as a perfect example. "If we insert a post at the top, to provide correct information....are we then responsible for all comments in the Sidewiki?"

BEST QUOTE OF THE MORNING:
Goes to the Center for Medicine in the Public Interest.

"Social media is too important to hide in a cave. It is communication at the speed of life."

Very few questions were asked by FDA. I don't think this is because they are not interested, rather, there are too many speakers with not enough time to think and dialogue.

To see the blow-by-blow of this morning and FDA Q&A visit the Twitter feed @roskadigital.com

In a discussion I had with contacts of ours at FDA yesterday, we eventually ended up discussing the upcoming hearings on social media and layout of the venue.

Most of the attendees at the upcoming FDA hearings on social media are already aware of the cell signal limitations and lack of WIFI at the proceedings (we've all tweeted and blogged about it to death). However, if this comes as news to you, and all of your live tweet and blog plans are now in question, do not to fret....there are a few simple things you can do to ensure your voice is heard (as close to real-time as possible).

1. Utilize more than one of your seats.
That's right...if you have more than one attendee from your organization...and you are not presenting or speaking at the moment, use one of your attendees as a 'runner'. While one member is sitting and listening to the proceedings, the other can 'run' up the escalator and be tweeting and blogging.

2. Make productive use of the breaks.
Whether it is the brief mid-morning/mid-afternoon or the longer lunch break...don't sit idle and let everyone else voice their opinion while you remain silent. Find the spot where you get the signal...and tweet and blog to your heart's content (and then get back before the next presentation starts).

3. Focus on quality, not quantity.
Nobody gives a hoot about what you have to say if it doesn't mean anything, or has no context. If you are going to tweet or blog, take the time to make it relate to your audience in meaningful ways. Volume means nothing. Quality means everything. So...even if you are going it alone, and can't communicate until after 5 each day, make your message count.

When was the last time FDA sought guidance from industry and agencies? Let's take advantage of this opportunity and provide real substance that will not only help open the doors for online 'discussion', but also make a positive impact in quality of care and demonstrate to FDA that we can be responsible in the new era of communications.

With less than 3 days to go until the social media hearings at FDA PhRMA calls for FDA to develop a mark or 'bug' to link to agency-approved product information and patient medical guides (yes, the same PhRMA that has significantly restricted pharma and agencies in recent DTP promotion guidelines).

An oxymoron of sorts...isn't it?

PhRMA SVP Ken Johnson issued a statement that "Leveraging the FDA's logo -- or a universal FDA-approved graphic symbol -- in search results and throughout the Web would inform patients, at a glance, that they were visiting a legitimate site that contains comprehensive FDA-regulated benefit and risk information."

Further, Johnson states that "Such a logo...could include a universal warning statement noting that all drugs carry risks and [invite] viewers to 'click here for more information'"

PhRMA suggests that this line of thinking would provide access to indication of risks when there is little space. These suggestions come as a 'preamble' to the trade group's testimony at FDA's public hearings later this week.

We used to view PhRMA as an obstacle -- a barrier to entry of sorts. Isn't it deliciously odd that we are now very strange bedfellows?

If you are wondering why your organic search results are lagging and your competition is beating you to the punch, you might want to rethink your SEO strategy.

Consider the following:

• On-page keyword usage comprises just 15% of the modern ranking algorithm
• Metadata is depreciating as the major search engines rely less on keyword and description metatags for search rankings
  

“Blended” or “universal” search – a practice of displaying varying media such as videos, images, blog entries and news along with standard search results – is becoming increasingly prevalent across the major search engines, making it critical to optimize all components of your web properties for search engine visibility.

As a result, all web property content – not only web pages but individual assets such as videos, images, and PDFs – need to be designed and deployed in such a way that they will be found and indexed by search engines.

Conclusion:

If you want to beat your competition, increase visibility, and ultimately drive traffic to your website, focus on your social media and linking strategies -- because SEO best practices from 2 years ago simply don't apply anymore.

November 12 and 13 FDA will be holding hearings to discuss a variety of topics around online advertising and social media. One question we need to ask ourselves is that, with all good intention, could FDA actually be HARMING patients through its restrictions?

Based on the warning letters recently issued by FDA, many agencies and pharmaceutical companies pulled back on their branded campaigns -- or even paused them, out of fear of receiving a warning letter from the FDA. The result? Let's look at one example from a campaign that was paused:

• 18% decrease in traffic from branded term, even while branded website holds #1 position in Google
• 64% decrease in traffic from generic term, in which the branded website holds the #3 position in Google

What does this mean? Opportunity for confusion.

By pausing the branded and generic ads, it opens the opportunity for other bidders -- outside of the healthcare space. Think about it. Lawyers can bid on these keywords. Competitors can bid on these keywords. Health websites with consumer-generated or inaccurate content can and do bid on these keywords.

In essence, health seekers trying to really find solutions to their healthcare needs may actually be confused and end up at the wrong destination. By creating these restrictions FDA may have actually introduced confusion in the minds of patients and caregivers, and may very well have done a disservice to quality healthcare as we know it.

Want to know more? Follow me live at the hearings November 12 and 13 via my Twitter account at twitter/roskadigital.

And, if you would like a summary of the proceedings, email me at kmueller@roskadigital.com to receive the summary of findings from the hearings.