With many industry folks saying it’s about time, the FDA just announced that it’s holding a public hearing to discuss social media. For years and years, the FDA has not addressed Internet-specific marketing so this week’s news is a huge acknowledgement that the Internet, social media tools like podcasts, and micro-blogging sites such as Facebook and Twitter are changing the face of marketing and advertising.
The public hearing, scheduled for November 12 and 13 in Washington D.C., is open to all interested parties such as consumers, patients, caregivers, patient groups, manufacturers, healthcare professionals and marketing agencies to provide their comments of Internet promotion. Armed with this information, the FDA will then make policy decisions on the promotion of human and animal prescription drugs, biologics and medical devices using the Internet and social media tools.
As a healthcare PR agency, our clients grapple with these issues every day as they look for guidance on what is acceptable and what could potentially land them in hot water with the FDA. Take Twitter, for instance. With its popularity growing in leaps and bounds every day, companies want to join the bandwagon and reach legions of people, but what is acceptable to say? With Tweets limited to 140 characters, do companies need to ensure that they are providing a fair and balanced view of the product including side effects or contraindications? Is this possible in 140 characters or less? Do they have to resort to haiku?
Many of our medical PR clients have also started Facebook pages to push messages out to consumers, healthcare professionals as well as the community at large to engage them and interact with them to learn more about their experiences with our clients’ products. One of the biggest questions that regularly gets asked is what if someone posts a comment on the Wall about an off-label use or adverse reaction. Is the company obligated to notify the FDA and is there a timeframe where this must be done? This is another key question that the FDA will be likely looking to address.
As a healthcare PR agency, we are definitely more than interested in the public hearings and especially what happens as a result. I suspect that many of our clients will provide comments and ask questions about this important discussion that is finally being addressed by the FDA. It will be a long process though as written and electronic comments are being accepted until February 28, 2010. Stay tuned for updates!
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Posted by Lauren Arnold on September 23, 2009 at 12:13 PM
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Every day now, ubiquitous across all types of media, both Democrats and Republicans are in full-throated discourse (a polite term) debating the future of America’s health care system. The discussion is decidedly unpolite, loud, passionate and to say the least, confusing. The Democrats, ardent supporters of major overhauls to our current healthcare system, have (to me anyway) yet to paint a cogent and articulate rationale for many of their proposals, and the Republicans, have fallen to pathetic imagery suggesting that our country’s senior citizens would be systematically denied life-saving care under measures advocated by the Democrats. How sad. But should we really be surprised?
Despite the assistance of world-class political consultants, communications pros, and talking head spinmeisters who are household names, both sides are grasping at straws in attempting to craft and then communicate simple, easy-to-understand messages that make real sense and resonate across political divides to the American people. I have to admit, that I am confused, and I deal in these issues almost every day. But again should this surprise us?
Think about it. Most of the hot button political issues of our time can be easily etched in the sharp contrasts of black and white. Go to war or not? Right to life or pro-choice? Gun control or not? Higher taxes or lower taxes? Soft on Crime? Hard on crime. The discussions surrounding these issues are easily framed and communicated. Why? Because they are simple. They are visceral in nature and professional political communicators have been easily able to manipulate the American public for decades now in driving home both their own positions and depositioning the competition with language and images that appeal to the lowest common denominator. Black and white stuff.
So, why are they having such a hard time with the healthcare discussion? Because the infrastructure, issues and care and cost basis of our healthcare system is, if nothing else, NOT simple. In fact, they are exceedingly complex. And almost incomprehensible to the average American. HMOs, PPOs, payors, caregivers, deductables, Medicaid, pre-existing conditions, wide variances in insurance coverage across economic and geographic stratas, medicare, co-pays, generics and on and on it goes. Whatever happened to the days when your own doctor came to your home with his little black bag? And then when you overlay the thicket of our current misunderstood system with new ideas and thinking, why it’s almost impossible to fully understand. It is exactly the complexity of all of this that has even the most experienced and savvy of the political PR pros scratching their heads---they’re not used to or capable of real substantive debate and discussion on complex issues. Give them the sizzle over the meat any day. You want to talk about capital punishment? Bring it on. Minimum wage? No problem. But the issues surrounding our healthcare system are deep and not easily simplified into sound bites.
So here is my suggestion. Democrats and Republicans alike should carefully consider retaining professional healthcare communicators in lieu of the political Lords of spin who are so obviously failing at convincing Americans on the merits of virtually anything at this point. Why? There are many fine healthcare and medical PR agencies across the country that are extremely adept at taking complex and sophisticated healthcare issues and translating them into simple, easy to understand messaging. These communications professionals have experience in representing virtually all of the players in the healthcare arena. Medical device companies with sophisticated technologies, consumer advocacy groups, pharmaceutical companies, insurance companies, physician groups, hospitals, research organizations and more. They are familiar with working in the regulated environment of our healthcare system. They are smart enough to realize that in America’s current healthcare system or even in a utopian one of the future, nothing is black and white. That there are nuances and shades of gray in most everything. Healthcare PR professionals would also not come at the communications challenge from a political perspective, but rather from an overall systemic viewpoint, in which the biggest challenge is education. And lastly, medical and healthcare pros realize that the biggest ally they could have in promoting a position is a fully informed and educated American public, not one kept in the dark by innuendo, negative images, and distortion of the facts.
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Posted by Lloyd Benson on September 14, 2009 at 11:56 AM
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As part of our role in healthcare PR, we frequently attend scientific conferences to help clients launch products and highlight new clinical research. Last week, I was fortunate to witness the largest cardiovascular meeting in the world, the European Society of Cardiology’s (ESC) annual congress in Barcelona, Spain. The Congress attracts more than 400 reporters to cover news and research from the conference.
A few headlines from the show:
A Focus on Prevention: ESC featured more than 25 scientific sessions on prevention, including the impact of smoking and obesity on cardiovascular health. The theme aligns with the increasing support—from policy makers and health providers—for identifying and treating disease earlier to help improve outcomes and reduce the cost of healthcare.
Ed Susman, a prominent medical reporter covering nearly every major scientific conference, features a review of the opening ceremonies and its focus on prevention
here.
The hot line research: The hot line research sessions typically attract the most attention from clinicians and the media. This year, results from RE-LY, PLATO and MADIT-CRT were the highlights. Check out
this MedPage Today video for a wrap-up about on the clinical implications of the studies.
Revisiting Drug-Eluting Stent Safety: Three years ago at ESC, two hot line sessions focused on first generation drug-eluting stents. New research there sparked a debate about the safety of the devices, raising questions about their ability to increase the risk of death. This year’s conference provided an update on emerging clinical evidence about DES safety, including a review of a large Swedish registry that analyzed nearly 50,000 patients who received stents. The take-away: safety data released since 2006 has reassured the majority of clinicians that DES are safe and effective.
The promise of genetics: The pursuit of personalized medicine continues. The Congress held several sessions featuring the topics of genetic screening and emerging research on cardiovascular-related genetics.
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scientific conference
Posted by Dana Conti on September 10, 2009 at 9:17 AM
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