September 2010

CDRH's Office of Compliance Increases Size of Device Advertising and Promotion Policy Group

Just a week ago, FDA Regulatory Counsel Deborah Wolf announced that CDRH’s Office of Compliance had tripled the size of its Advertising and Promotion Policy Group.

Now truthfully, the staff increase from one to three members pales compared to FDA’s drug center, which employs 60 staffers in a similar role. But device companies should be able to easily read the tea leaves on this move, which should also come as no surprise. For medical device public relations, marketing, regulatory and legal counsel folks, the smoke signals coming from FDA have been clear for some time. Medical device companies will begin to fall under the same type of microscope that the drug industry has been under for some time. This initial staffing increase is likely just the first of more to come as funding becomes available.

And central to the FDA’S more vigorous examination will be the promotion and marketing of off-label usage. It is also our belief that FDA will also be more closely examining the promotion of unfounded claims that lack substantiation in science and lack the approval of FDA. Expect closer examination of Internet-based information, including of course your own Web Site. I recently read of one instance where a company’s web site contained an investor-level presentation by a clinical investigator on the results of off-label studies. The off-label study itself is, of course, perfectly acceptable, but the FDA viewed the posting on the company’s web site as promotional and zing! - off went a warning letter.

If this renewed attention hasn’t already resulted in your company developing and executing a compliance program then you are already behind. A good summary of the issues and components can be found here. 

It is vital that your public relations agency and marketing consultants not only be aware of the issues, but have undergone compliance training themselves. We’re proud that our healthcare staff here at Schwartz has, and thus provides another level of security to the healthcare PR pros and marketers who engage us.

Posted by Lloyd Benson on September 29, 2010 at 10:40 AM
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The Rewards of Putting Effort into Awards

We came across a new award program that we’re considering for some of our clients in the HCIT practice group – The EHR Game Changers Awards sponsored by Health Data Management. There is still time to submit nominations for healthcare stakeholders who have “helped in the evolution of EHR technology and its increasing adoption by provider organizations.” The deadline is September 24. 

Why spend time and resources submitting nominations for awards like the EHR Game Changers? Here are a few important reasons:

Get Info: Many times, awards honor technology implementations or use at customer sites. A challenge PR pros often have is identifying customers who will agree to serve as media references. However, healthcare organizations may welcome an offer to submit an award on their behalf and promote their innovative thinking and positive results they achieved by using technology. What does that mean for the HCIT vendor? It presents an opportunity to screen a user and develop a testimonial about the use of a product or service in order to complete the nomination forms. This content can be used in a variety of ways once the nomination form is approved by the customer and submitted. For instance, the material could be the foundation of a byline, case study or speaking submission, or to bolster a media pitch.

Get Noticed: While we all want to win an award, the process of submitting the nomination form is valuable regardless. Judges – who are often members of the editorial staff when awards are sponsored by publications – will become more aware of your company, products and customers. When pitching those same reporters and editors, it’s helpful to be able to reference an award submission. So, while a nomination might not have been selected among what is likely a large pool of equally impressive submissions, the customer name and results will likely stay at top of mind for judges. 

Get Ink: The best possible outcome—a win—is usually accompanied by a large feature story in the sponsoring publication. Editors generally write stories from the nomination form, calling attention to impressive stats and outcomes. Other awards and honors can lead to opportunities beyond the sponsoring publication.

Many times, the bigger award programs offer template releases that are pre-approved and include information about the logistics of the award. The company can also post the award logo to its company website and email signature line, and use it for marketing purposes. 

Generally, we’ve found that many award deadlines come up around early spring, but a few more to track this year include:

Modern Healthcare’s Spirit of Excellence Awards honors organizations and individuals that go above and beyond to serve patients and communities – Due October 15 

American Hospital Association Leadership Awards offers several awards for distinguished service and innovation, among others – Due the first week in December 

American Hospital Association Nova Award, honors effective, collaborative programs focused on improving community health status – Due December 3

The 2011 Edison Awards, sponsored by Discovery Channel, The Nielsen Company and Google, recognizes top innovations and innovators – Due December 10 

In summary, awards can be a valuable marketing tool and help gain awareness, and illustrate your innovation, industry leadership and vision.

Posted by Mercedes Carrasco on September 22, 2010 at 10:13 AM
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Eli Lilly Takes Up Blogging

Pharma, biotech and medical device companies aren't terribly cowboy when it comes to corporate communications. I'd describe the general mindset as not so much "why wouldn't I share this information?" as "how does disclosing this information help me?"

It's not that they don't want to market their companies, their therapies and their expertise, because they do. But on a day-to-day basis, they ask themselves "why THIS piece of information?" They're thoughtful about their approach and nothing really happens without someone, or several someones, having given the release of that information substantial thought.

Nevertheless, the trend in external communications across technology and, I'd argue, science-driven industries, is toward having conversations that unfold over time and away from orchestrated releases of information. Of course, this isn't exclusively the case--if your company is announcing data or presenting at a conference, an embargo is an embargo and you will clearly not be dripping that data out via Twitter over time.

Keeping our eye on that broad trend, we notice that Eli Lilly has introduced a corporate blog, LillyPad. It's not pharma's first blogging effort, but as someone who looks at both the regulated world of healthcare communications and trends in PR, I can't help but believe that the blog represents an interesting step forward for healthcare communicators.

(By the way, for a fantastic read, check out Eye on FDA's late August post, "Slogging Through Blogging as a Highly Regulated Industry--Some Thoughts for Pharma in the Blogosphere." Or, for the Schwartz take on biotech blogging in particular, "5 Reasons Why Your B2B Biotech Company Should Blog.")

Lilly isn't using their blog to talk about their science or anything of that nature--they're discussing issues that matter to their company. Innovation, the value of patents, math and science education and the obligatory post on helping uninsured patients pay for medicine. Closer to home, I look at the example of client Absorption Systems, which has started blogging in order to explore topics that matter to their company, like drug-drug interactions and direct-to-patient marketing.

Lilly's comments policy reads, in part: "Comments on this blog will be filtered by Lilly and may be subject to removal if they have inappropriate content. Because Lilly and its affiliates operate in highly regulated industries, comments pertaining to ongoing legal matters or regulated content will not be posted."

Clearly the company isn't going to display posts from patients who feel they may have experienced negative or unwanted side effects. The worry of so many healthcare companies is, naturally, "what if someone reports an adverse event?" Lilly has put in place a process that allows them to gather that information if it comes their way and to respond directly with patients if need be. I think they've also shown, in just a few posts, that there are plenty of topics that the company feels are in its best interest to talk about in this sort of forum.

If blogging still isn't something your healthcare company feels comfortable exploring, maybe you're getting your feet wet in social media with Twitter instead. At Schwartz, we've noted that most big healthcare companies with products on the market are active users of Twitter. If ever you need convincing that social media has taken hold in the life sciences industry, visit the Dose of Digital social media wiki for a listing of just how much material is out there.

Our strong belief is that social and traditional media are intertwined--that one can't really be pursed in the absence of the other anymore. Even if your company isn't blogging, bloggers matter to you. You might not be on Twitter, but you should at least know what patients and others are saying about you there. Monitoring is the first step and a precursor to determining the level of involvement that's right for your company.

In the meantime, it's encouraging to see a company with the heft of Eli Lilly jump on the opportunity and commit to blogging. Is it something your marketing team has considered?

Posted by Laura Kempke on September 15, 2010 at 3:03 PM
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A Preview of Health 2.0 with Matthew Holt

I am speaking with Matthew Holt, a San Francisco-based healthcare policy guru and entrepreneur, founder of The Health Care Blog and co-founder of successful Health 2.0 conference, which will take place in San Francisco on October 7 and 8.
 
Matthew, congratulations on coming up to the 4th annual Health 2.0 conference. Given your original tagline, "user-generated healthcare," you certainly have foresight into where healthcare is now and will be going.

Do you see that tagline as being relevant for a long time?
 
User-generated content in healthcare will become more and more relevant, and we get contributions of information and data from more and more people, reporting on their conditions, their experiences, using tools that track their care consciously or automatically. And then that data stream will be picked up by more sophisticated analytic tools, and used in the decision-making process by consumers, providers and everyone else.

It's actually the first part of our four stages of Health 2.0:

1) User-generated healthcare
2) Consumers connecting with providers using simple tools
3) Partnerships using Health 2.0 technologies to reform delivery, and
4) Data (from all those processes) being used to change clinical decisions and eventually drug discovery. But all those stages are going on simultaneously and we're really just getting started.

Eventually, the division between user-generated content and expert-created content will disappear, and no one will realize that we were having this conversation back in the day...

What do you see as the most important technologies in healthcare that will help move the mountain of Health Reform?

Email. Web tools for communication between doctors and patients. Self-service information tools for patients. On- and off-line communities for patients (and others) for support advice and information.

The rest of health reform needs aggressive government regulation and financing reform, which it might just get some of if we're lucky post PPACA (Patient Protection and Affordable Care Act).
 
I'm sure you're seeing some interesting companies and products to showcase next month. Can you give our audience a sneak peek into some of the companies to watch? Some of the sessions which you're particularly excited about?

Just too many to count. We've collected a database of over 650 companies doing interesting things. We feel like they’re all our babies, so I'm loathe to pick winners but here's a few that we're reviewed in recent days:

Tweet What You Eat - a food diary using crowdsourcing to guess calories of things that are not in the USDA database and Twitter (simple & ingenious) to record information.

iMoveYou  - uses Twitter, Facebook and more to challenge friends and friends of friends to do better in health, exercise and more. Started by Jen McCabe a former Health 2.0 conference intern, so that one, we're very proud of!

Performance Clinical Systems – A SaaS based presentation layer for getting admission orders off paper in small hospitals. It does what the big EMR vendors do for a fraction of the cost

All of these are small, relatively unknown companies. We also have some much bigger players including Microsoft, Google and WebMD doing interesting stuff supporting and integrating new tools and technologies.

And we have several sessions showing developers integrating government data into their systems and answering 11 challenges we have incubated as part of the Health 2.0 Developer Challenge. US Department of Health and Human Services CTO Todd Park and Federal CTO Aneesh Chopra will be here to highlight that session

Oh, and we'll be hosting the two biggest start-up launches of this (or any recent year). The first is Sharecare, with WebMD founder Jeff Arnold & Dr Oz and many more, and the other one is Castlight Health, which just raised $80m in venture funding to blow up and reinvent healthcare shopping for employees and consumers.

What kinds of companies and products do you look for when you're selecting presenters at Health 2.0?

Innovative, easily intuitive, tackling an obvious problem in a new way; not afraid to tilt at windmills, and of course, one that will demo well! 
 
How have you seen Health 2.0 impact the players in healthcare – vendors, physicians, patients, pharma, biotech, insurers and so forth?

Anyone who touches the consumer is starting to realize that this matters. Everyone else is in for a rude shock when they understand that the Web 2.0 tools that are getting used at the edges of healthcare will be invading their enterprises--in the not-too-distant future.

Is there anything you'd like to say which I haven't asked?

Thanks for asking.

We're running a short meeting before the main conference called Patients 2.0 in which some remarkable patients and caregivers will be telling their stories. We've always had patients sprinkled through Health 2.0, and increasingly we're just giving them their own sessions and letting them lead.

Please have your clients and readers get involved in the Health 2.0 community, come to the conferences, listen to the webinars, get involved in the Health 2.0 Developer Challenge. We've been going for four years, but this is really just starting.

Matthew, thank you very much for your time. We look forward to seeing you in San Francisco next month.

Posted by Davida Dinerman on September 7, 2010 at 9:19 AM
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Thoughts on upcoming European events from a PR perspective

We are constantly being asked for advice on the conference and exhibition scene in Europe, and so with budgeting season coming up with alarming speed after the summer, here are a few tips on the current situation.

In general, shows related to drug discovery remain surprisingly strong, although we see growth of more niche therapeutic orientated shows with anything between 100 and 700 participants. Often these are the result of bundling by smaller organisers such as Select Biosciences (e.g. Stem Cells, Cellular Therapy and Biobanking in Edinburgh) to make economic sense, or by bigger conference groups, such as Terrapinn, striking lucky in the sector with their World Vaccine Congress in Lyon and Antibody Meeting in Geneva. Another interesting development we at Schwartz are involved with is the European Cancer Cluster Partnering Meeting bringing together biotechs, pharma, and investors in oncology.

On the device side, whilst diagnostics shows are limited, there is a bit of a resurgence. A good example of this resurgence is the recent ECIO (European Conference on Interventional Oncology) in Florence, which attracted a lot of interest despite being held in the heat of July after initially being postponed because of the dust cloud. Of course Medica still looms large, and should be your first port of call to meet potential distributors and get a feel for the market. Similarly, Analytica and Biotechnica are worth noting, but still need local German support to be worthwhile.

Moving on to biotechs, you could almost set up camp here since the calendar remains pretty full, starting with JP Morgan in January, running through Bio-Europe Spring in Milan in March, BioEquity in June in Germany/Switzerland, BPE in London in October and Bio-Europe in November (my personal favourite). The focus at all of these is on financing and partnering, and you will find it relatively easy to make contacts both the official way through the "partnering software" and unofficially through the networking over drinks/dinner etc. Another thing to remember is that organisers are constantly looking for a "fresh point of view" and so by putting yourself forward as a speaker or panel discussion member you can often offset your costs. Local meetings vary in strength across Europe, but it is worth looking at the UK again - with the ERBI (now One Nucleus) and Genesis conferences which bring together most of UK's biotech and Thistle Biotech in Scotland andBiotech Forum in Scandinavia.

Finally if you are looking to find out what's going on and just don't have the time to pop over, you can meet most of Europe at BIO or the ones in your field at the relevant major US show every year. And of course Schwartz is always willing to provide advice - I sit on various biotech and other network steering committees on a UK and European level and have plenty of contacts as does Kristina Ebenius in our Stockholm office.
 

Posted by Richard Hayhurst on September 1, 2010 at 5:16 PM
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