Schwartz PRx

Healthcare PR: BioImagene's Build to USCAP

2010-03-12T18:03:06Z

Say what you will about the effectiveness of conferences in the marketing mix--there are still a lot of shows that companies feel they have to attend in order to see and be seen. In the case of Schwartz client BioImagene, that conference is the annual meeting of the U.S. & Canadian Academy of Pathology (USCAP).

BioImagene is one of the companies that dominate USCAP and their PR team is working overtime to support the show presence. So it was nice for everyone to see a blog entry, "BioImagene PR Doing It The Apple Way," from New York-based pathology resident Karl Robstad, M.D.

Dr. Robstad offers, "In an industry that, at least in my opinion, lacks some of the excitement in spreading the word about their newest and best products/services, BioImagene is a real stand-out taking a page out of Apple’s handbook, by creating mystique and hype around product releases, and then following the hype up with grand spectacle unveilings."

He continues, "You can look at stuff like this and call them 'PR stunts' or whatever, but I think there is a certain amount of merit behind a good PR campaign."

We'd agree, Dr. Robstad, and thank you for noticing. It's all about generating the sort of visibility that makes the BioImagene sales team happy and that underscores how a company that was founded a few years ago is altering a century-old industry.

The BioImagene booth was hopping at USCAP last year. Here's to an even more successful 2010 event later this month.

This photo from euthman is covered by a Creative Commons license.

HIMSS 2010 - A Few More (Observations) from the Road

2010-03-08T15:42:00Z

Following are additional impressions from HIMSS 2010, Atlanta contributed by Schwartz Communications colleagues Dave Close, Nigel Smith, Dana Conti, Mercedes Fereck…

•   Bloggers vs. reporters: There is hardly a difference in the healthcare IT market. Prominent bloggers like HISTalk attract big readerships - large enough to host their own party and awards ceremony on the same night as Healthcare Informatics’ Innovators Awards Event. At a client’s press briefing, bloggers sat next to top tier outlets like Modern Healthcare, providing their own perspective and reporting on the news. Take Anthony Guerra for instance. He is the former editor of Healthcare Informatics, who is now leveraging his CIO contacts to write stories on his new site healthsystemCIO.com

•   Booth Gimmicks Abound: From the aforementioned DeLorean, to a specially constructed basketball court featuring former Harlem Globetrotters to Tiki-themed lairs and Vespa giveaways, HIMSS once again featured some pretty memorable booths. I can certainly appreciate the scenery, but it seems somewhat "Mad Men" retro and a bit silly to see companies still hire beautiful young women to draw traffic into the booths. Every spokes-model in the southeast must have been at the GWC. How do you stand for seven hours on six-inch heels?

•   Wither the CIO? There weren’t as many hospital CIO types roaming the show floor as in years’ past. Many we spoke with said the CIO was an “endangered species” at HIMSS and most who did attend were there as a guest of a vendor. So, HIMSS this year was mostly vendors talking to vendors, with the most likely business outcome being strategic partnerships down the road, or planting seeds for a future merger or acquisition.

•   Testing The Waters: This year at HIMSS, Schwartz met with a number of general technology vendors who were there to “test the waters” of the healthcare vertical market and/or to gather information on healthcare IT certification.

Let us know your thoughts of the show….

HIMSS 2010 - Play It Pretty For Atlanta

2010-03-05T19:41:11Z

Once again this year, Schwartz was the lone PR firm with a booth at the Healthcare Information and Management Systems Society (HIMSS) conference, which was attended by 9 of our clients and wrapped up yesterday. They were there along with some 30,000 other healthcare IT professionals, all eager to hear the latest on "Meaningful Use," Electronic Health Records, HITECH, ARRA and how to secure federal stimulus dollars. Hundreds of vendors exhibited in two huge exhibition halls, ensuring my pedometer registered up to 8,000 show floor steps per day. Good thing, considering the spectacularly unhealthy fare offered at the food stalls throughout the Georgia World Congress Center.

Following are a few observations about the show, including contributions from Schwartz VPs Dana Conti and Dave Close, who attended HIMSS along with 5 other colleagues:

•   It seems that every six months, the number of media outlets shooting video on the conference floor doubles. Publications like DotMed and Healthcare IT News tape interviews during the day and edit stories at night. And you thought you had a long day at the booth?

•   The land grab for HIE contracts is on. Everyone from major players like GE to niche HIE vendors are highlighting their ability to support the next healthcare technology infrastructure...and reporters wanted to hear from anyone with an HIE pitch.

•   So many EHRs. It seems like everyone is developing or offering an EHR with the story that it’s a logical extension of what they do – whatever it is they do. We met a fascinating guy from South America who developed an EHR for racehorses. He was at HIMSS to find opportunities to sell if for human patients. Why not? He’ll have to change the parameters for the size of a urine sample, though.

•   Some version of the phrase “meaningful use” was in the signage or literature in almost every booth. Last year everyone was waiting for the definition. This year there is a definition and it’s moved very quickly into the marketing spiels of hundreds of companies.

•   Perhaps the most appropriate visual metaphor to healthcare IT today was in the booth that had a “Back to the Future” DeLorean. One of the engineers had built the thing and it’s an amazing facsimile of the real movie car. He said it has 200,000 miles on it and he drives it to the shows. An old, obsolete car covered with all sorts of futuristic technology bolted all over it to make it do new things. At HIMSS you saw so much fantastic technology – EMRs, PACs, PHRs, HIEs, analytics…all sorts of new tech to make the old, clunky healthcare system faster and better. But I can’t help thinking that until there is some type of structural reform, it’s still 21st century tech bolted onto a creaky, obsolete system.

Stay tuned for more HIMSS observations.....

Biotech, Pharmaceutical Companies Listen to Social Media

2010-02-23T21:10:12Z

Yesterday the Boston Business Journal ran an overview, "Biotechs proceed with social-media caution," of the state of affairs in drug companies' use of Web 2.0 platforms like Facebook, Twitter and blogs.

As you'd expect, this is an issue tracked carefully by every PR firm in Boston, San Francisco and other areas where the drug and medical device industries are concentrated.

As we all know, companies that market therapies and medical devices in the U.S. have to be prudent in their use of social media. Lacking FDA guidance, they generally believe that they need to steer clear of anything that might be deemed promotional. (John Moore of Chilmark Research boils it down for readers in the Boston Business Journal article: "How do you have clear disclaimers in 140 characters?") And what if patients make claims that aren't supported by FDA labeling? Or report side effects that the drug or device company can't verify?

Yet, as the article points out, people are talking anyway--patients and their families will continue to search online for information about conditions and treatments--and biotech and medical device companies increasingly feel that they have to at least listen to those conversations.

I've heard some ask, "Why would I listen when I can't respond?" That mindset strikes me as too tactically focused and short-sighted. A response to that post or that tweet may be out of the question, but any effective external communications program has to be based on a reasonably comprehensive understanding of how your product is perceived.

Beyond that, as the article and other discussions of pharmaceutical marketing have pointed out, companies can still make some use of social media as a channel to reach target audiences. They might be hamstrung at this moment in time in not being free to engage in every two-way conversation, but pharmaceutical and medical device companies should be able to get creative in their use of social media to disseminate some types of information, such as facts about a particular medical condition and tips on its management that have nothing to do with a drug or device.

Jim Weinrebe from Schwartz attended the November 2009 FDA hearings on social media and opined, at the time, that "active listening and monitoring" of social media by drug and device companies would gradually become seen as "safe" and would not go hand in hand with a requirement to "police."

Pharma and device companies are listening to what's being said online and some are beginning to go a bit beyond. None of these firms are giving consumer brands a run for their money in use of social media, but it's clear that they should at least begin to listen. Perceiving social media use as "all or nothing" isn't in line with industry leaders' current thinking.

Innovation and Growth in Swedish Medtech

2010-02-18T19:26:26Z

Written by guest blogger Karl Hultén, Schwartz Stockholm

An extensive analysis, based on a recent survey, confirms that the Swedish medtech industry is highly innovative and evolving. The export share of the industry is high, 86 percent, and the U.S. is seen as the most important market.

Within the next three years, the number of new products is expected to rise by 24 percent. Most companies in the survey are involved in diagnostics, cardiovascular therapies and orthopedics. The survey was conducted by the research firm Synergus at the request of Swedish Medtech, Invest in Sweden Agency, SwedenBIO, Innovationsbron and VINNOVA.

In August, 2009, 96 Swedish medtech companies responded to questions about business prospects, corporate structure and number of products and projects to be developed. The answers indicate that the industry is gearing up for international growth.

Companies in the survey estimate a 24 percent increase in number of products on the market by 2012. Smaller sized companies tend to be more involved in the development of new products than larger companies. A majority of the participating companies regard the development of international sales as the biggest challenge.

Clinical evidence is essential for 74 percent of the companies and the number of clinical trials is expected to grow dramatically over the next three years.

The Swedish and U.S. markets have a long history of co-development and synergy effects. Over the coming years this bond is expected to grow even stronger.

Companies to watch:

Bactiguard

– Making medical devices deadly, for bacteria

Antibiotic resistance is a growing threat. In Europe alone at least 25.000 people die each year because of antibiotic resistant bacterial infections. On February 9, 2010 Göran Hägglund, Swedish minister of Health and Social Affairs, held a press conference in which he said that “Every year 3 000 people die unnecessarily in Swedish health care, due to lacking routines.” Most of these casualties are caused by hospital acquired infections. Bactiguard is a clinically proven product for preventing these types of infections. It consists of a thin metal alloy which is antimicrobial and biocompatible. This coating can be applied to any medical device. This is a Swedish invention that unlike most other medical devices also is produced in Sweden. It is a very interesting product with a lot of potential because of the great challenges that lie ahead in working against the spread of multiresistant bacterial infections.

http://www.bactiguard.com/

Airsonett

– Challenging big pharma

There is always a risk of contaminating wounds in the operating room. Dust can carry with it multi-resistant bacteria that sometimes cause lethal infections. Preventing infections could lower readmission and mortality rates and save hospitals large expenses. Airsonett has developed a unique technology for infection control in operation rooms (Opragon) based on clean room technology. The company also applies the technology in prophylactic treatment of allergic asthma (Protexo). What’s interesting and unique is that Airsonett now challenges the big pharmaceutical giants. Their products could compete with long term treatment of asthma (inhaler), which is a big deal. The company has its roots in the clean room industry (AirSon AB) but has now moved into these new and exciting fields.

http://www.airsonett.com/

Healthcare PR: Hospitals Leading the Way in Social Media

2010-02-12T23:42:55Z

My old hometown newspaper, the Rochester (Minn.) Post-Bulletin, covers happenings at Mayo Clinic with regularity. (Absolutely everyone called it "the Clinic" when I was growing up, but since I'm in communications I'll try to respect the fact that they've dropped the "the" and mean it about the "Mayo" part.)

An article in the paper this week, "Mayo Clinic Looks Toward the Future," describes how things went last year for the hospital, "a $7 billion nonprofit company that employs more than 32,000 people in Rochester." Sounds like things were a bit rough, but that Mayo, which also has a huge presence in Arizona and Florida, finished the year in good shape.

Looking ahead, to grow, "Mayo plans to use everything from social media and 'telemedicine' to remote clinic locations [potentially outside of the U.S.] to accomplish that goal."

Mayo is already, as just about everyone in healthcare PR knows, phenomenally active and I believe creative in its use of social media. (For a start, check out the Sharing Mayo Clinic blog.) I'll be very interested to see what Mayo's got up its sleeve in 2010 when it comes to using social media to reach patients and consumers, both in the U.S. and abroad.

Much has been made among healthcare marketers of how hamstrung pharmaceutical and medical device companies are, or perceive themselves to be, in their use of social media in the absence of FDA guidance. Hospitals, however, have jumped right in.

To keep current on this topic, check out the Found In Cache blog. It's full of charts and useful resources (e.g., "Over 1,000 Hospital Social Media Sites") on use of social media by hospitals.

You may want to also read HealthLeadersMedia's late January article "Few Hospitals Use Social Media Effectively, Says Study." It says that only 12.5% of respondents to a survey--hospital marketers--had succeeded in attracting new patients using social media.

With social media use on the rise--consider that the fastest growing demographic on Facebook is women over the age of 55--maybe hospitals will see greater returns on their use of social media in 2010.

Photo credit: Visit this page for information on this photo of the Mayo building. This photo is covered by an open source license.

Social media for B-to-B health care companies: Is there value?

2010-01-29T19:11:19Z

There is tremendous buzz about using social media to promote all things consumer including health care treatments and diagnostics. But what if your company markets to hospital administrators and clinicians instead of patients? Does that mean there is no value for your company to engage in social media?

When thinking about how the medical community is using social media, the perception tends to be that social media sites like Facebook and YouTube are only used to target patients, however also present are influential medical organizations and health care companies targeting clinicians and hospital administrators. The Society of Interventional Radiology (SIR) has a Facebook fan page that communicates updates on SIR's upcoming meetings, announces webinars and provides video clips of clinicians sharing their experiences using interventional radiology to treat patients. YouTube is also full of these types of videos designed for physicians to observe cutting-edge practices in surgery, diagnostics and other treatments.

With regards to targeting health care administrators, social media sites designed for professional networking--such as LinkedIn and Twitter--can be strategic venues for developing a presence for your brand. While LinkedIn is best known for providing individuals with a trusted network of business professionals to help them identify job opportunities, there is another component to LinkedIn that is conducive for helping to brand companies as key opinion leaders in their industries. With more than 55 million members including executives at every Fortune 500 company, LinkedIn provides a channel to get in front of key decision-makers in the health care business world.

Even better, it's very easy to begin building a corporate presence on LinkedIn. In minutes you can create a company profile that is essentially the same as the boilerplate section of a corporate website. Also simple to do is forming a LinkedIn group, a more interactive forum than a company profile that is designed to be a place for sharing industry and/or corporate news and allows members to begin discussions with one another. It is a great place to upload links to media coverage about your company as well as interesting articles about the industry.

One of the important choices when setting up a group is to either make it open to anyone who wants to join vs. invite-only. There are pros and cons to both options. If the group is going to be comprised of company executives who want to use it as a forum to share information between one another, then it would be best to set up the group as invite-only to prevent sharing information inadvertently with competitors who may unknowingly join a public group. If however, the number one goal of setting up the group is to elevate the company's brand to any and all business professionals, the public option will make it easier for more folks to join and would be the best choice. Also, it should be noted that if an inappropriate comment is posted, the group manager has the ability to delete the comment and/or subsequent comments in the discussion as well as remove "difficult" members from the group.

That said, it is important to remember that social media sites are not well suited to keeping information private. Anything you post to a LinkedIn group could be seen by clients, prospective clients and competitors. Social media sites such as Facebook and LinkedIn frequently change their privacy policies and settings. When changes are made they are not always transparently communicated to members.

If the idea of driving discussion seems too aggressive, there is still value in familiarizing yourself with outlets such as LinkedIn and Twitter. Like all communications campaigns, the key lies in finding outlets that reach your desired audience. Even if you're not ready to engage proactively, just listening to what business professionals in your industry are talking about can help inform how you go about reaching them. To this end, sites like Sermo are conducive to learning how physicians think about a particular topic. There are sponsorship opportunities available for companies to post questions and have access to the clinicians' answers, something that could be worthwhile if you are researching the best way to position a new product or relaunch an old one.

So the answer then is, yes, absolutely there is value for B-to-B health care companies to engage in social media, and we didn't even delve into opportunities on Twitter. Come back soon for a post dedicated to best practices on Twitter for health care companies with both B-to-B and B-to-C selling models.

Inspiration and Perspiration in PR

2010-01-27T14:21:54Z

Yesterday I met with an interesting company that was interviewing healthcare public relations agencies. They had developed a detailed set of criteria for the PR agency that they were going to select. This is not uncommon, in fact, it is de rigeur. In this case, management kept coming back to their desire to hire an agency that “thinks out of the box,” and is “highly creative.” Not the “normal type of healthcare or medical PR” agency.” Understandably they also placed a premium on results, with the goal of selecting the agency that could combine their intellectual and creative assets with a solid track record of delivering for their clients.

Our discussion made me think of Colleen, a senior account executive at Schwartz. For years Colleen and I have worked together on a non-branded campaign to heighten awareness of Obstructive Sleep Apnea (OSA). The target media for the campaign has always been consumer-type media of all kinds - daily newspapers, women’s books, men’s publications, family magazines, etc. - the hardest and most difficult coverage to land. We have been hugely successful in our campaign, due largely to an account team composed of people like Colleen.

Around three years ago (yes years!) Colleen first interested a senior editor at Self in writing a piece on OSA. This was a key outlet for us because women are gatekeepers to family health and our research had shown that spouses and significant others frequently “turned their husbands and boyfriends in” due to excessive snoring - a leading indicator of OSA. Colleen was thrilled since Self is a such a tough “get.” She sent information to the editor but the piece kept on getting pushed out. The editor left Self and Colleen had to start over again and again and again…Every time important new studies came out on OSA, Colleen would renew negotiations with a revolving cast of editors. As Ahab, it became her Moby Dick. Time passed but Colleen would not be deterred. Then one blessed day last month, Colleen arrived at our meeting breathless with the news that after getting a freelance writer interested in writing the story for Self and prodding her to conduct interviews, the piece was finally going to run in the January 2010 issue of Self. And you know what? It did. Here’s an abbreviated version:

What's really keeping you awake

So, what does any of this have to do with the company I met with yesterday? Like them, I believe that great healthcare PR people need to be creative and be willing to leave traditional ideas behind and think expansively and “out of the box.” Over the years on this campaign we had consistently provided the client with some really great, innovative concepts. BUT….and this is a big “but,” more than anything, the best PR people I know are tenacious, “never-say-die” advocates for their clients. I have always thought that great healthcare PR or PR of any kind actually combine a dose of healthy inspiration with a continuous dose of perspiration. While companies sometimes think that there must be a magic bullet or mysterious secret sauce to what we do, I disagree. It’s pretty simple if you think of it.

Creativity and brilliant strategy is essential to all effective PR.campaigns. We take great pride in our ideas here at Schwartz. But sometimes it is the sheer effort of a bright, energetic, tireless, undefeatable PR pro - like Colleen - that makes the difference. In PR as in life, there’s no real substitute for going the extra yard.

The Changing Media Landscape: What it Means for Healthcare Companies

2010-01-26T13:58:31Z

When you convene a group of leading healthcare journalists, in front of a room full of healthcare PR professionals, sometimes there's no telling what you might hear. Journalists and PR folk, especially healthcare PR agency specialists, have a bit of a love hate relationship. We both need each other, for different reasons of course, and in light of the different media world we live in today, it's more critical than ever that we best understand how we can help each other. As a PR practitioner, I'm most concerned with finding creative and impactful ways for my medical device, biotech and biopharmaceutical clients to get their message out to their key target audiences. The game has changed and in fact continues to change on what often seems like a minute-to-minute basis. OK, maybe I'm exaggerating but you get the point.

To that end, we prepared a special report with our takeaways from this session, thoughts on how the media environment is altering communications strategies and ideas on how healthcare companies can capture the right mix of influential mindshare. Is it shocking that healthcare journalists are busy (no), have fewer resources (no) and have less time to pursue feature-based stories (no)? How about the fact that several of the reporters we heard from have yet to jump on the social media bandwagon? Probably not shocking, but interesting, yes especially when the media organizations they write for are knee deep in trying to drive eyeballs to their respective Web sites via the multitude of social media tools and channels available. Check out the report and read on to uncover the good, bad and the ugly of what to expect in 2010. Feel free to opine on our blog with your thoughts and observations, we would love to hear from you.

New York Times Report on Radiation: Balanced or too Sensational?

2010-01-25T22:27:09Z

The January 24th edition of the Sunday New York Times ran a Page One Investigative report on the perils and dire consequences on the use of radiation in medical diagnostics and cancer therapies. The lengthy report, put together by an investigative team of six people, left the reader chilled and saddened for the families of the two patients whose experiences formed the substance of the vast majority of the Times’ reporting. Indeed they suffered greatly as a result of what the Times inferred was a result of a human error and/or faults in complex technology. Rare will be the reader who will put the piece down believing as much in the safety and efficacy of radiation as when they began reading.

Yet the Report was both disconcerting and troublesome to me. As a healthcare public relations professional, I have indeed represented companies who had developed both radiation diagnostics and various types of therapies, yet even so, I found I was not biased by my professional associations. What really was disturbing to me was this quote found in the 9th paragraph of the 4 full page article.

“Without a doubt, radiation saves countless lives, and serious accidents are rare.”

OK. I get that—and I believe it. For many years radiation based protocols have been the standard of care and indeed gold standard in more procedures than I have time to list here. And this knowledge, juxtaposed with the Times reporting of yesterday is totally perplexing to me. I feel that the Times reporting was both sensationalistic and severely unbalanced. If they were to use all of that hugely expensive space in the Sunday paper detailing the potentially dangerous applications of radiation, would not a great deal larger amount of space be required to tell the stories of just some of the “countless” number of lives that the Times says radiation therapy has saved. I don’t get it.

Of course medical error and improper use of new and different technologies are serious problems. They deserve to be covered and extensively reported on. But to run such an emotional and one-sided account as the Times did, disappoints me. Not only as a healthcare PR Pro, but also as an informed potential patient. I love the Times. It is my favorite newspaper and a ‘must-read’ every day. But in this case they fell far short of their usually high journalistic standards. And in doing so, carried out an injustice to their readers by painting a picture that only tells a small, small part of the story.

FDA Social Media Hearings: Day 2

2009-11-13T20:36:52Z

As two jam-packed days of testimony near a conclusion, one powerful theme continued to resonate from drug and device companies and associated vendors: If emergent FDA regulations on participation in social media are so onerous that they serve to deter drug and device makers from being in this arena, the commercial stage will be entirely left to unregulated entities including marketers of alternative health remedies, off-shore pharmacies peddling potentially counterfeit or unapproved therapies and a tidal wave of law firms provoking panic about branded Rx products in an effort to recruit vulnerable consumers for class action lawsuits. This result, it is argued, creates a vacuum that would leave the Internet the sole commercial province of companies whose messages and products aren't validated via clinical trials or accountable in any way to the FDA.

The Agency was repeatedly implored to collaboratively identify and establish responsible but practical, realistic ways to enable responsible industry participation in social media. Among the oft repeated suggestions was for FDA to recognize that regulations must be tailored to the unique technology attributes of social media channels and tools, and mindful of the staggering volume of content generated every second.
Vehemently crusading against allowing industry to more easily participate in social media was a spokesman from Consumer's Union, who warned FDA to not repeat what he asserted has been the dire consequence of DTC advertising in traditional media. The Internet, the spokesman warned, only offers more opportunity for deceptive and sinister marketing practices by an industry that he apparently believes is not to be trusted.

Social media, industry argued, could actually help FDA better achieve its public health and safety mission with respect to effective communication with the public. Current regulations mandating comprehensive detail of all labeling and safety information, regardless of format, it was stated, result in a blur of fine print or voice-over garble that nobody can read, hear or understand. It was argued that these regulations serve as more of a legal mandate than an effective communications mandate.

Through Its interactive, linking, searching and click-through capabilities, industry advocates contended, social media offers tools and formats that could be mobilized by companies and FDA alike to establish a new paradigm for communicating accurate and understandable health information in a simpler and more accessible way to the public.

Many terrific, specific suggestions were illustrated. One can only hope the FDA was truly listening.

Adverse Event Reporting Commentary Leads Day 2 of FDA Social Media Hearings: MedWatch a Focal Point

2009-11-13T15:06:32Z

From Jim Weinrebe, live from the hearings:

Look for MedWatch to become an increasingly "go to' website for consumers experiencing problems they believe are associated with their prescription therapies.

We're barely 30 minutes into the morning's agenda on what Internet regulations should exist for adverse event reporting, and two speakers have already spotlighted the need to make the MedWatch site more consumer-friendly and accessible. One speaker represented Consumer's Union, and the other was a woman whose husband commited suicide after taking anti-depressants that were associated with the potential for suicidal tendencies.

Both speakers urged FDA to actively promote the MedWatch site to consumers, with one noting that most consumers aren't even aware of its existence and what it's used for. Promotion of MedWatch should be supplemented by modifying its language and process to facilitate easier use by consumers in the reporting of adverse events, the speakers both noted.

The Consumer Union spokesperson stated that manufacturers should be required to post prominent links on any website not only specific to a branded drug, but also non-branded disease awareness sites controlled by the company and even third party group websites of which the manufacturer is a substantial sponsor.

Looking down the road, highlighting MedWatch and facilitating links to the site appear to be a likely point of consensus among all parties. It makes a ton of sense from both a public health and industry reporting burden perspective. More to come.

FDA Social Media Hearings Part Deux: TO MONITOR OR NOT TO MONITOR? AND WHAT'S UP WITH GOOGLE?

2009-11-13T02:44:31Z

One of the most strongly, consistently stated tenets about social media is that if a company does nothing else, it should at least actively "listen." But for regulated drug and device companies, what if listening and monitoring yields mountains of hard to vet, potentially adverse event information that must be reported? Or uncontrolled consumer discussion and posting of off-label use of regulated drugs and devices for which a manufacturer could theoretically be held accountable?

If comments from presenters and questions from FDA at today's hearings are any indication, there will be a glacier-like but inevitable move toward policy that codifies the "safety" of active listening and monitoring without a corresponding and untenable burden of accountability for Internet "policing" beyond what a manufacturer has created or sponsored.

There were several suggestions for FDA to define what could be constituted as "best effort" for monitoring and reporting. What will that be? Stay tuned but don't hold your breath.

Similarly, industry presenters repeatedly recommended prominent use of links within manufacturer-controlled content to the FDA web site where product-specific safety and labeling information resides, and also to the MedWatch site where adverse events can be officially reported.

It was abundantly clear that industry -- not FDA -- will lead the regulators to viable solutions.

Meanwhile, wrapping up the day was Google, which in a remarkable display of audacity didn't utter a peep about SideWiki. Go figure. Good thing for Google it was the end of a long day and people were in no mood to linger and interrogate.

Commentary on FDA Hearings on Social Media

2009-11-12T18:14:22Z

From Jim Weinrebe, EVP at Schwartz Communications, live from the FDA open hearings on use of the Internet and Social Media Tools in Promotion of FDA-Regulated Products:

Four hours of testimony has just concluded, with statements from product manufacturers and their trade associations, communication firms, lawyers and non-profits and health advocates. As suggestion after suggestion piled up as to what industry and FDA can or should do to find an acceptable middle ground between industry participation in social media and realistic regulatory requirements for monitoring of and accountability for correcting inaccurate information, one fundamental question loomed un-stated. That is, until the very end of the morning session: How can an already capacity-constrained FDA that struggles to expedite its current mandate possibly find the organizational funds and staffing to take on all the activities associated with social media monitoring and policing? The firm recommendation from Diana Zuckerman, representative of the National Research Center for Women and families and a harsh industry critic, is to institute user fees for that very purpose. A formal proposal toward that end is pending, according to Zuckerman, who also "outed" several product brands and companies for Internet communication that she alleged was lack of compliance with existing requirements for risk disclosure. Certainly a wake-up call and provocative way to end the morning.

All Eyes on the FDA

2009-11-10T22:35:33Z

For healthcare PR executives, all eyes will be on the FDA later this week with its first public hearing focused on social media. Schwartz’s Executive Vice President Jim Weinrebe and Vice President Jayme Maniatis will be attending the two day public hearing on November 12 and 13 and will report back on key findings.

Check back later this for our expert commentary and top takeaways from the proceedings.

Should be an exciting two days in Washington D.C. and the results will have tremendous implications for all healthcare PR practitioners. Stay tuned!