The FDA public hearings on the use of the Internet and social media to promote FDA-regulated medical products drew hundreds of presenters and thousands of written comments. Although the FDA isn't expected to issue formal rules or guidance until late next year at the earliest, the initial response among stakeholders has been positive.
The FDA public hearings on the use of the Internet and social media to promote FDA-regulated medical products drew hundreds of presenters and thousands of written comments. Although the FDA isn’t expected to issue formal rules or guidance until late next year at the earliest, the initial response among stakeholders has been positive.
On November 12-13, the FDA held “a public hearing to provide an opportunity for broad public participation and comment on promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools” (http://tinyurl.com/yzobpqb). At this meeting, a variety of stakeholders—including consumers, patients, caregivers, healthcare professionals, patient groups, Internet vendors, advertising agencies, and pharma industry representatives—were allotted 10-15 minutes to offer comments and pose questions to help guide the FDA “in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools.” Nearly 1,000 registrants had hoped to sit in on this meeting, but only 300 were granted access, leaving the rest of the world, MDNG included, to follow along on Twitter. Among those who were able to speak at the FDA meetings were several names that should be familiar to MDNG readers; each presenter is well known in the digital-marketing-meets-big-pharma-meets-social-media ï¬eld, and they all had great insights following the meeting in Washington, DC.
Fard Johnmar, founder of Envision Solutions
What was the biggest surprise at the hearings?
For anyone familiar with the pharmaceutical industry, getting key players to agree on anything is quite an accomplishment. Given this, perhaps the big- gest surprise of the hearing was that everyone—from agencies to consumer advocates—agreed on the importance of the Internet and social media for drug ï¬ rms, patients, and others. While they disagreed on how to address this issue, at least they were on the same page about the Internet’s importance.
What were some of the best proposals regarding rules and regulations for pharma’s presence in the social media sector?
I think there were many great suggestions, but the three that stood out for me were:
• Google’s recommendation on how to incorporate fair balance informa- tion within sponsored text advertisements (http://tr.im/ERIu)
• Ogilvy’s “Three C’s” recommendation on how to address the issue of inï¬‚uence on online conversation (http://tr.im/EmDf)
• PhRMA’s recommendation on the development of an FDA seal of approval on online content. While I think this recommendation poses many, many problems—especially when it comes to veriï¬cation—a visual indication of quality online content backed by the FDA or another government agency would be tremendously helpful (http://tr.im/ECOe).
Where do you think the FDA will go from here? What do you think they should do?
I think the FDA will take time to hear from a range of stakeholders about this issue. They will ultimately come up with guidelines—hopefully before the end of next year. However, people expecting comprehensive guidance from the FDA might be waiting in vain. The FDA may decide to bite off smaller parts of the regulatory pie in order to determine how advocates, policy makers, the industry, and others will respond to their evolving regulatory stance. I hope the FDA forms an outside advisory board that will provide them with diverse and informed perspectives on how the Internet is changing how people receive and consume health information.
Jon Richman, Director of Strategic Planning at Bridge Worldwide and author of the blog Dose of Digital www.doseofdigital.com
Could you provide your initial feedback from these meetings, focusing on how the discussion and forthcoming regulations will impact physicians and their relationship with their patients?
I’m not sure the meetings will immediately impact physicians. Certainly though, they should have heard loud and clear that people are turning to the Internet--in many cases before consulting with a physician--and are being inï¬‚ uenced by what they ï¬nd. Much of the information they ï¬nd is in the form of “social media,” with patients sharing their opinions with one another. But this isn’t new news. Physicians have seen this for years and regularly report that most patients arrive in their ofï¬ ces having done some sort of online research. Most welcome this, but it does make their job tougher, as they are required to spend more time explaining infor- mation that people ï¬ nd online. Eventually, should pharma companies increase their participation in social media, more people could come requesting speciï¬c medications or asking about symptoms they have that suggests a disease they heard about via a discussion that a pharma company was involved in. However, I don’t think that the overall volume will change much. As direct-to-consumer television ads are used less, perhaps the number of people coming in because of a commercial they saw will go down, but the number of people who see something online will go up.
Physicians may need to take on a larger role as more companies begin to participate in social media, should new guidelines encourage it. I think a more proactive approach is important for physicians. Most people won’t make a ï¬ nal treatment decision without talking to their doctor. They’ll go
Interested in ï¬nding more information on the FDA hearings? Go to www.fdasm.com to ï¬nd all the presentations, Twitter discussions, and relevant articles and blog postings.
online and ï¬nd a mix of quality and questionable information. Some people sort this out for themselves, and others turn to their doctors to do this. In the end, it could save a lot of time and potentially dangerous situations if physicians proactively told their patients where to go online for more information. They know their patients are going to do it, so why not guide where they look and help point them toward highly credible sources?
I’m not sure I’ve seen a ton of solutions to the lack of regulations at this point. One important thing to keep in mind is that a lack of regulations hasn’t stopped a huge number of healthcare companies from participating in social media already. I’ve been compiling a list for almost a year and have hundreds of examples (http://tinyurl.com/ps4lrr). Remember that there isn’t a lack of guidelines altogether, there is a lack of social media guide- lines. The same promotional rules that the FDA has always had still apply. If these are followed, you can’t get into trouble. Keeping that in mind, you quickly realize that there is quite a bit that you can do in social media and still stay within current regulations.
Wendy Blackburn, Executive Vice President of IntouchSolutions digital marketing
and author of the blog ePharma Rx
With so many different outlets, it may be nearly impossible for the FDA to effectively regulate this space or rectify all of the misinformation. How can the FDA possibly monitor something as massive as social media?
Tools and technologies exist today that would help monitor the social space to some degree. But it’s not realistic to expect the FDA (or pharma companies, for that matter) to be able to monitor every single social media channel and every conversation. I think the best anyone can expect is a “spot-check” approach, much like they do now for print, broadcast, Web, and other forms of advertising. They will catch some things, and others they won’t.
What were the one or two key things that you learned from the public hearings?
1) There are many passionate stakeholders in this debate, but unfortunately what we heard at the hearings was a rather one-sided view. We need to hear more from the consumer/patient perspective.
2) The FDA is publicly recognizing the uniqueness and importance of the Internet as a whole, and of social media as an element of that. The hearing was a ï¬rst step. There will be many more discussions to come, and I hope it will be two-way conversation between the FDA and the industry.
What do you believe might be the next steps the FDA will take, and how will their actions affect physicians?
First, all stakeholders need to take the time to submit written comments to the FDA, and they have until the end of February to do so. The hearing was only two days of short presentations. The written comments have no space constraints and allow for detailed, data-driven testimonies. If physicians, patients, and companies have an opinion on these issues (and I expect most do), they need to be sure the FDA knows about it. The FDA will closely evaluate this information to form their recommendations. Do physicians want to continue to be able to talk freely with their peers about case studies, treatments, and care in social media settings, even if the information is off-label? Do they want to be able to have an open (documented) online dialogue with pharmaceutical companies? Do they a dialogue with patients, and within what parameters (eg, promotional, correction of misinformation, compliance help, customer service sup- port)? If they have an opinion, now is the time to speak up.
Perhaps (and I hope they will) the FDA will form a committee that includes stakeholders to help work through the issues and formulate clear policies. Physicians need to be a part of this process. As for timing, I expect the FDA will issue guidance by end of 2010 or early 2011.
Physicians need to be aware of how consumers search for and ï¬ nd information on the Internet. There is a lot of good information, but there is also a lot of misinformation out there. Physicians need to partner with their patients to ensure the “right” information is getting through, adverse events are being reported through the appropriate channels, and patients have access to all the information they need.
How did you come up with the idea for the RxRISK logo, and what were some of the other proposed solutions? (See slides 21-29 of Blackburn’s presentation for more on RxRISK: http://tinyurl.com/y8h2x88)
My company, Intouch Solutions, has been doing online marketing for pharmaceutical companies for 11 years, so working within the constraints of this space is something we think a lot about. I was trying to come up with a solution that would potentially meet the needs of the four key enti- ties involved in pharma promotional marketing:
1. The FDA needs to make sure consumers clearly understand the risks associated with any pharma product or medical device. Pharma products and medical devices are serious business, and companies need to be responsible in communicating risk information.
2. Pharmaceutical companies need to be able to communicate both beneï¬ ts and risks, even in places where space is constrained (search ads, Twi ter, etc). They need to be able to get that information into the hands of patients who are looking for it. They need guidance from the FDA on a standard, consistent way to do that without getting a warning letter.
3. Physicians need their patients to be informed, but they also need them to have all sides of the story.
4. Patients need to be able to ï¬nd information about treatment and prod- ucts, when and where they are searching for that information.
RxRISK seemed to meet these criteria with kind of an “in-your-face” approach to linking to risk information whenever a product is mentioned. And with the combination of the image and the link, I believe that it’s ï¬‚ exible enough to work for future Internet and social media platforms that haven’t yet been conceived. PhRMA proposed a similar solution using a logo that communicates that a product had been “FDA-approved.” The thinking behind that was to differentiate regulated, credible information with some of the more questionable information out there. Others proposed that FDA hire more social-media-savvy employees. And several people suggest FDA form a task force or committee to help develop and evaluate policies now and on an ongoing basis, which I think makes a lot of sense.
Are there any additional resources you might point physicians toward?
Three are a couple of grassroots websites that are great resources for more in- formation on the FDA hearing and also serve as a gateway to related presenta- tions, blog posts, articles, and other resources. I’d recommend www.fdasm.com and http://tinyurl.com/y85vyqq. If you’re on Twitter, you can follow the hashtag #fdasm for ongoing discussions. Finally, the FDA has a site (albeit static), featuring information and think it would be helpful or hurtful for pharmaceutical companies to have links on the topic at http://tinyurl.com/ yzobpqb, which includes instructions for submitting written comments.