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.
Tags:
fda,
fdasm,
social media
Posted by Lloyd Benson on November 13, 2009 at 3:36 PM
| TrackBack (0)
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.
Tags:
FDA,
social media
Posted by Lloyd Benson on at 10:06 AM
| TrackBack (0)
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.
Tags:
FDA,
Social Media
Posted by Jim Weinrebe on November 12, 2009 at 9:44 PM
| TrackBack (0)
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.
Tags:
FDA,
Social Media
Posted by Jim Weinrebe on at 1:14 PM
| TrackBack (0)
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!
Tags:
FDA,
healthcare PR,
social media
Posted by Lauren Arnold on November 10, 2009 at 5:35 PM
| TrackBack (0)
Jim Weinrebe presented his perspective on the role social media is playing in crisis communications management for biotech, life science and pharmaceutical companies at the Publicity Club of New England's "Crisis Communications Preparedness" program held at Schwartz Communications.
Jim, along with his fellow panelists, weighed in on the need to plan, plan, and then plan some more as it's still at the root of any good crisis communications or reputation management plan for healthcare PR. Simply put, you can't be too careful, or too prepared in today's digital media age. It's not so much that many of the fundamentals have changed but that the SPEED, unbiquity of communication and new product applications in social media, with Google Sidewiki offered as just one recent example, have the potential to outpace the planning capabilities of some of even the most seasoned practitioners.
What's very different today in healthcare, according to Jim, is diminished ability of healthcare prescription product manufacturers to control, manage or even respond to messages that are swirling around them in the social media universe. With the prolific growth in use of Twitter, blogs, Facebook, YouTube, Flickr and other channels, social media content is not only broadly influencing people online, but also becoming a feeding ground for resource-constrained traditional media outlets that are constantly seeking audience generated content to embellish their reporting. The news vetting bar has never been set so low for provocative content that can get instantly posted and then picked up by influential traditional broadcast and print outlets in the blink of an eye.
While one of the fundamental rules for participation in social media is to actively listen, Jim also noted that even this basic aspect of social media etiquette poses difficult challenges for healthcare prescription product manufacturers, who could be accountable to the FDA for reporting instances of adverse events that have been identified through social media monitoring. It was noted that the industry is seeking clarity from the FDA on these and other issues related to social media, which could be at least partially forthcoming in pending public hearings on this topic in mid-November. Until such guidance is established, Weinrebe noted, prescription healthcare product manufacturer participation in social media will be very modest, and for the most part resembling more of a web 1.0 than a web 2.0 format. Meanwhile, Weinrebe said that social media has more potential to create or accelerate crisis for healthcare prescription product manufacturers. Exceptions in healthcare cited by Weinrebe were organizations like the Centers for Disease Control and American Red Cross, and even individual hospitals, who have employed sophisticated uses of social media to help effectively manage and communicate messages during public health emergencies and crises.
Jim noted that in regulated industries, such as healthcare and finance, there is still a lot of work to be done in educating senior management about the need to apply authenticity in tone to social media communications, even if the communications are nothing more than stand-by statements or simple acknowledgment that a problem has occurred. Jim counseled attendees to consider social media monitoring tools as a core part of an effective public relations strategy, while at the same noting that many healthcare product manufacturers need more guidance on adverse events reporting before even that approach can be robustly implemented.
While the healthcare industry waits with suspense for the outcomes of the FDA hearings on social media, Jim noted that clarity will not be achieved in the short term, that the deliberations will continue well into 2010 and that even by that point and beyond, a certain degree of ambiguity may still be desired by regulatory agencies as a means for cultivating preemptive manufacturer caution.
Tags:
biotech PR,
healthcare PR,
medical device PR,
medical PR,
public relations agencies,
Social Media
Posted by Risa Goldman Burgess on November 3, 2009 at 9:32 AM
| TrackBack (0)
