Don’t Wait for Comprehensive Social Media Guidance
Tags: social media, Pharma, FDA, guidelinesOn December 31st, the FDA finally released its long awaited guidance on the use of social media, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices." (click to download the actual PDF). As most of us expected, the FDA did not provide comprehensive guidance.
Read more » « CollapseSocial Media and Its Impact on the Healthcare Industry
Tags: social media, HCNM, Pharma, Facebook, YouTube, Twitter, medicine, health systems, FDA, CDC, physician
Today, 650 hospitals have an active presence on Facebook, YouTube and Twitter and numerous healthcare organizations have turned the corner to engage in conversations online. As we look back on the impact social media has had on the healthcare industry over the past year, we see dramatic growth in social media adoption by health care consumers, providers, and organizations.
For example, health systems such as Henry Ford have begun to broadcast surgeries and answer clinical questions live via Twitter, new communities like WiserTogether have made it easier for patients to share novel practices around specific conditions such as pregnancy, and services such as iGuard have changed the way we think about drug safety. The FDA’s public hearings in November also gave hope that the cloud of regulatory uncertainty would soon be lifted and the Dose of Digital Wiki now lists hundreds of active pharmaceutical social media programs.
While the industry has taken a giant leap forward into the brave new social media world, we've only scratched the surface of what is yet to come. So what does the future hold? Join me June 14th in Chicago, as Shahid Shah (CEO of HITSphere) and I explore the past and future at the 2nd Annual Healthcare New Media Marketing Conference. Our talk kicks off a terrific event, and I am honored to join the distinguished group of speakers Q1 Productions has assembled.
The Limits of Manufacturer Accountability in Social Media
Tags: Pharma, Bayer Schering Pharma, Pfizer, AstraZeneca, Oglivy, Sanofi-Aventis, FDAIn its call for public comments on the promotion of regulated medical products using the internet and social media, the FDA sparked renewed interest in the role the agency's guidelines might play in pharma's embrace or avoidance of social media. While many manufacturers have moved forward with innovative programs (See the Pharma and Healthcare Social Media Wiki) there are still organizations unsure or simply unwilling to engage online in an uncertain regulatory environment.
It's easy for some to accept that fear and hesitancy are warranted when billion dollar blockbuster drug franchises and patient safety are at stake. Yet, those of us who believe the power of the social web can improve both the bottom line and the public good will continue to push pharma to engage more openly and effectively online. As an example, Digital Pharma Europe is being hosted by Bayer Schering Pharma in Berlin this week. While I cannot attend in person, I will follow along via twitter (use #digpharm) and am encouraged by the fact that Bayer, among others, is taking social media seriously in Europe. Joining with Bayer in their respective comments to the FDA, manufacturers demonstrated they can come together to provide a near unanimous opinion on issues relating to the use of social media (See our summary of PhRMA comments here).
When it comes to defining what they should be held accountable for online, PhRMA, Abbot Labs, AstraZeneca, Bayer, Eli Lilly, Genentech, Johnson & Johnson, Novartis, Pfizer, Sanofi-Aventis, and Sepracor seek to limit accountability to content that is company owned and controlled. Novartis proposes that companies “should only be held accountable for those online communications which they directly own or control", while Pfizer distinguishes between company-controlled web properties and company-controlled content, saying that “statements by unregulated persons on manufacturer-hosted (or -supported) online forums are not statements by the manufacturers themselves.”
If the FDA adopted these recommendations today, would manufacturers more fully embrace social media? One would hope so, but in the absence of formal guidance, manufacturers still hesitate to engage openly with patients and providers alike. Behind closed walls on manufacturer sponsored or controlled private sites for patients and providers, some allow real conversations to take place. However, on the public sites they control, such as branded and unbranded Facebook pages, most manufacturers restrict commenting and often disable posting all together. If patients and providers can't engage the brand or company in an open conversation online because the manufacturer fears being held accountable for their statements, how much value does a presence on Facebook really provide? Clearly, we need to encourage more open, engaging and credible conversations in these settings. Without such an approach, we will continue to see manufacturers stumble in their social media efforts, as recent events illustrate.
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FDA Framework for Regulating Social Media Promotion
Tags: social media, BioPharma, Pharma, FDA, physician social networks
On March 16th, Ozmosis submitted its comment to the FDA's docket on the promotion of regulated medical products using the internet and social media, joining over 150 other submissions by drug manufacturers, health systems, consultants, agencies, advocacy groups, and private individuals. 
The level of interest in this subject should surprise no one.
The world of medicine has changed dramatically since the FDA's last hearings on internet use. In 1999, less than 50% of physicians used the internet for professional purposes. Today, Google reports that virtually all physicians (92%) use the internet to gather medical information in a clinical setting, and according to Manhattan Research, 89% of U.S. physicians now describe the web as "essential to their professional practice." With the groundswell for social media resources among physicians continuing to rise, Manhattan Research also shares that 71% of U.S. physicians are interested in or already use physician social networks for peer-to-peer interactions.
However, many pharmaceutical manufacturers hesitate to engage with physicians through social media due to the uncertain regulatory landscape. While there have been notable exceptions, as highlighted in our FDA comment, this missed opportunity is a detriment to patients, providers and manufacturers alike. We strongly encourage the FDA to provide clear guidance to avoid further delay.
So what would appropriate guidance for manufacturer participation look like? At Ozmosis, we have established a set of principles that, if applied to the broader web and social media landscape, would be to the benefit of manufacturers, physicians, and patients alike.
On Ozmosis, physicians use their real identities and share their professional affiliations, resulting in a more trusted and transparent exchange of clinical information. Since physicians always know with whom they are communicating and sharing knowledge, the insights and discussions that take place on Ozmosis are highly valued and insight rich. Any regulatory framework put forth must ensure the same level of trust, transparency and accountability our physicians already benefit from every day.
Read more » « CollapseA Call To Action: FDA, Social Media and Physician Engagement
Tags: social media, Pharma, FDA, physicians, GI Circle
Joel Selzer (LinkedIn profile), my Co-Founder at Ozmosis, has spent the past few weeks following the buildup to the FDA's Public Hearing on Social Media. After digesting last week's testimony and the conversations around it (visit www.fdasm.com for the latest courtesy of Fabio Gratton), Joel offers the following:
During my recent presentations at Digital Pharma and AdvaMed's Social Media Seminar, I argued that social media offers pharmaceutical and medical device brands a unique opportunity to engage with physicians. According to Mark Bard from Manhattan Research, 70% of physicians want pharmaceutical firms to engage them online and 60% of physicians either use or are interested in using physician social networks (just ask the docs on Ozmosis or Sermo). With thousands of physicians actively using social media every day to access and share medical information (see Rohit Bhargava's post on "How Doctors Are Using Social Media", one would expect pharmaceutical and medical device firms to salivate at the engagement possibilities.
Yet, both industries have been reluctant to engage doctors using social media under current FDA guidelines. Their reluctance has been disappointing to many but should not be surprising. Michele Sharp of Eli Lilly said it best at the FDA hearing:
To date, Lilly has avoided significant interaction with healthcare professionals and patients about our products in social media forums – largely because of a lack of clarity in understanding FDA’s expectations as to how we could participate and comply with FDA requirements.
This theme was reiterated throughout the hearings, and its absolutely critical that the FDA evaluate the impact of not providing guidance. Michele Sharp also nailed it when she called on the FDA to lead a series of public workshops that could, "collectively generate ideas, leverage the knowledge, expertise and experiences of the participants and work toward viable solutions, so that FDA can provide the detail and clarity to the pharmaceutical industry and others through Guidance or executive channels."
Lilly's recommendation is spot on, but in addition to immediately scheduling a series of public workshops…the FDA should appoint a Social Media Advisory Panel (a recommendation echoed by Zen Chu of Accelerated Medical Ventures). While holding the public hearings was a great step forward, the FDA needs to augment its social media expertise and it needs to do so quickly. Its clear from last week's testimony that the FDA has a lot of homework piling up and the best way we can accelerate their education is to demonstrate two very important points about social media use to the FDA.
1. Physicians and industry are already working together
2. Practical solutions exist to address the FDA's concerns
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Health 2.0 2009, San Francisco, Day 2: A Summary
Tags: healthcare, FDA, Health 2.0, Keas, Athena Health
Three CEO's and a President offered interesting perspectives on where they felt Health 2.0 was heading. Alexandra Drane, President of Eliza, made a fascinating point about how most of the data out there is not very useful until it is cleaned with some high touch effort. Eliza actually contacts patients to confirm and clean up data - she mentioned that 20% of the people who were reported to have diabetes, didn't have diabetes - all you have to do is ask!
Jane Sarasohn Kahn moderated a great conversation between Wayne Gattinella of WebMD, Sameer Samat of Google Health, and David Cerino of Microsoft. I was blown away with how clean the new MS HealthVault interface looks (using Silverlight) - it was like looking at a Mac! Google showcased a new telehealth solution, MDLiveCare, that is now integrated with their system and uses video chat to deliver medical and psychiatric services to patients. Wayne focused heavily on their new WebMD mobile apps that he feels (and I agree) are where tools need to be delivered.
Sanjay Koyani from the FDA showed a demo of their Twitter feeds and widgets - similar to what he shared in the Driving the Adoption of Health IT Through Innovations in Social Media. Jamie Haywood from PatientsLikeMe discussed their recent study that was based on data gleaned from their site about lithium and Multiple Sclerosis.
Adam Bosworth did a demo of Keas today. The site has come a long way since last year. Care plans now help consumers improve their health by helping them keep on track with their specific disease state. Adam described it as a "Facebook for health" which gives you steps to better health. There is a slick integration with Quest Labs that turns the raw data into very nice visualizations that are easy to interpret. Keas allows for some personalized and relevant data to be delivered to the patient based on their condition. It is definitely shaping up and I look forward to seeing how it develops over the coming months. Well done Keas, keep it simple and stay out of the red.
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Driving Health IT Through Innovations in Social Media
Tags: social media, FDA, Health IT, CDC, Clinovations, HHS, NIH, Amplify Public Affairs
With close to $40 billion in stimulus funding specifically appropriated for Health IT adoption and a wave of successful initiatives utilizing social media for public health, key decision makers need to understand the full potential social media has to affect positive change for healthcare reform. We already know the Obama Administration believes Social Media offers a low cost way to improve transparency and drive community engagement, and earlier this year we shared Six Ideas where Social Media could be used to ease and improve the HIT integration process. Now, we need to ensure that the right stakeholders join the conversation.
To help educate policy makers and advance the discussion, Ozmosis is co-hosting a Symposium on Thursday, July 16th with Amplify Public Affairs and Clinovations, entitled, "Driving Health IT Through Innovations in Social Media." We have a terrific group of speakers from CDC, FDA, HHS, NIH and the private sector who will demonstrate the success of and lessons learned from existing social media programs in the federal, state and private health sectors.
