HealthCentral's FDA Public Hearing Testimony: Questions 1, 2 and 5

Christopher M. Schroeder — November 13, 2009

Questions #1 and #2 FDA Testimony

Good afternoon. My name is Chris Schroeder and I am the CEO of HealthCentral and I am pleased to return.

I am honored to be here today to share two perspectives: my perspective as the CEO of an online media company whose mission is to empower people to improve and take control of their health and well-being, and the perspectives of our millions of users as well.

While I will address Questions 1 and 2 specifically, there are four key points I suggest are central to all of your considerations:

First and foremost, Americans are exponentially seeking information and having conversations on the internet to take control of their health decision-making. The internet and social media represent a seismic shift in the way consumers inform themselves about and deal with their health decision-making and communications.
Smart, effective and balanced DTC advertising – especially online, unencumbered by space or time limitations – is a uniquely powerful tool to promote health literacy. It is, in fact, is the only part of these significant online conversations that is regulated.
The internet is significantly different than television, radio, or print and its unique interactive, searchable, linkable, multimedia, and multi-device characteristics require specific FDA guidance; however, the underlying principles of truthful, transparent, balanced and accurate DTC advertising should be the same, regardless of the medium.
Consistent with the FDA’s goal of increased transparency, it is crucial that the FDA act quickly to provide clear, specific guidance with respect to online DTC advertising and the use of social media. Advertisers and internet companies can only engage people at times of need if we understand how the FDA’s regulations with respect to drug and device promotion apply to the internet, a medium that is distinct from print and broadcast media in powerful and significant ways.

The magnitude and permanence of this shift in health-seeking behavior cannot be overstated – I know you’ve heard and read the aggregate numbers of Pew and others.

But in addition to the sheer size of online health activity, the unprecedented specificity is equally astounding. In a quick review of various social media sources last month that:

There are now more than 5,000 Yahoo user groups on depression
There are now more than 100,000 people in Facebook diabetes groups
There were recently nearly 500 posts on ADHD in a 24-hour period on Twitter
There were recently more than 200 posts on Ambien in a 24-hour period on Twitter
There were over 201,000 searches on “Concerta;” 110,000 searches on “anxiety treatment;” 41,000 searches on “Cymbalta side effects” in Sept. on Google alone.

The sheer size and specificity of these activities are one of the most exciting developments in human communication, and offer unprecedented opportunity for everyone to better engage and educate.

With respect to Question #1 regarding the responsibilities of pharmaceutical and medical device companies for online communications, first and foremost, I believe transparency is the watchword for not only health but all marketers. The test is quite simple – at no point should a user have any confusion as to the source of the information that he or she is considering.

Material on any website or social network that is provided by an advertiser must be clearly labeled as such. Where the advertiser has exercised editorial control or influence over the content or nature of the discussion or material, then the advertiser’s role in the creation of such material or discussion or influence over its content should be stated clearly so that it is transparent to the reader.

The FTC’s recent Guidelines relating to Bloggers are also relevant in this context as the role of advertisers paying or influencing individual bloggers will now be more clearly transparent to consumers. I think that increased coordination on these matters with other agencies such as the FTC and state regulators can also contribute to a more consistent regulatory environment that helps consumers and promotes public health.

With respect to accountability for third party content online, Americans are increasingly having conversations online that used to take place in person. Trying to make pharmaceutical and medical device companies accountable for those conversations will keep those companies from engaging consumers online. To be clear, this would eliminate the only vetted and regulated messaging available to consumers exactly when they are seeking such information and looking to take action.

In part due to a current lack of specific online guidance from the FDA, most pharmaceutical and medical device companies are unwilling to advertise next to the user-generated content in the community sections of online health websites. These companies are concerned that having their advertisements next to a posting by a user that discusses an off-label use of their product could trigger liability for promoting an unapproved use for their product.

Trying to make drug and device companies accountable for the online communications of the general public on sites not owned by such companies would be analogous to making a DTC advertiser on a live television broadcast accountable for the content of a statement by a guest on the program. Pharmaceutical and medical device companies should only be accountable for their own online communications, and for third party online communications that they pay for or over which they exercise editorial control or influence. To be clear, just because a pharmaceutical or medical device company runs a DTC advertisement on a webpage should not make them accountable for the content of that page.

With respect to Question 2, I believe that the internet is a powerful tool that promotes health literacy and uniquely enables advertisers to meet critical regulatory requirements. I believe that the following principles are critical:

Because of its searchable, interactive, linkable, updatable and unlimited characteristics, the internet is uniquely suited to facilitate the communication by DTC advertisers of all required prescribing information in a more engaging, useful and accessible way for consumers. I will suggest that DTC advertising online can make the required risk/ benefit information more accessible and comprehensible to health seekers on their terms, when they are engaged, without any space limitations.
Concerns about having risk information “one click away” should be rethought as it actually offers an exciting opportunity to help online health seekers. I would suggest that a clear, interactive call to find out more about safety or adverse effect warnings in clear English, linking to a clear, patient – friendly brief summary would be unprecedented in its ability to help inform consumers. Just as television DTC advertisements are allowed to refer to risk information on a website or in a magazine advertisement, so too should direct links from an online display advertisement to such information be acceptable.
The combination of search engines driving traffic to highly specific content and contextual advertising online means that online DTC advertising can be tailored with much greater specificity to particular audiences. Unlike print and broadcast media, the interactive and searchable nature of the internet enables consumers to seek out and find highly specific information regarding their health concerns. Studies show, and our own internal data supports, that the vast majority of people who come to health web sites come from a search engine having initiated a specific health query. In this context, the advertising and the information of risks and benefits that it conveys is an important part of the consumer’s aggregation of information. The hyper-contextual targeting of advertising on the internet is a key distinction from print and broadcast media that makes the advertising more useful to the consumer as it is more likely to be specifically relevant to their concern.

Conclusion

In conclusion, I want to emphasize the growing importance of the internet and online DTC advertising to America’s health literacy. The national conversation about health is moving online and it is critical that the FDA recognize this fact and provide clear, internet-specific guidance to advertisers and online health companies so that the power of the internet can be harnessed to best promote public health.

Question #5

Good Morning. My name is Chris Schroeder and I am the CEO of HealthCentral.

HealthCentral owns and operates a collection of over 35 targeted, condition specific, consumer health websites that attract more than 12 million unique visitors each month. Our websites combine unique and impactful content with highly engaged communities of online health seekers who share experiences, advice, empathy and support to help each other manage their health decisions.

I am something of a veteran of the online media world – having run online legislative/regulatory resource Legi-Slate, as well as the online news organizations washingtonpost.com and newsweek.msnbc.com. I have watched, often in amazement, the power unleashed by the internet, enabling people to find information on any topic and connect with others who share their interest. This enormous, growing and living system of information and interconnections is unprecedented historically, and its ramifications are just beginning to be understood.

I want to thank the FDA for calling these very important hearings at this crucial time, am pleased to address you question regarding adverse even reporting online in two themes.

First, it is my firm belief that there is a unique opportunity for an increased collaboration between the FDA and online health and social media companies to dramatically improve adverse event reporting.

We recently conducted a survey of nearly 1,000 users of our websites. 89% of those surveyed said that they would call their doctor if they had a bad reaction to a medication – obviously a good thing. Interestingly, only 1% said that they would contact the FDA and 2.3% said that they would share their experience on an online forum.

This data underscores an unprecedented opportunity for the development and syndication of online tools to reach millions and better enable consumers to more easily report adverse drugs events directly to the FDA. HealthCentral and other online health companies can work with the FDA to develop these tools and promote them to their users. We have some ideas we will submit to you in writing, as I know others here will. I strongly recommend that the FDA expand its existing efforts to work more broadly with online health companies to facilitate the collection of adverse event reporting data.

Second, consistent with the FDA’s goal of increased transparency, it is crucial that the FDA act quickly to provide clear, specific guidance with respect to online DTC Advertising, social media and adverse event reporting.
As a key example, there should be greater clarity with respect to what the word “sponsor” means in terms of the adverse event reporting obligations of pharmaceutical companies.
Our recommendation is that the FDA makes clear at what point a company is obligated to monitor adverse event reports on third party web sites. I believe the FDA should make clear that mere advertising on a webpage does not constitute “sponsorship” — requiring companies to monitor such content.
Instead, “sponsorship” should be limited to the following circumstances:

The pharmaceutical company owns or has editorial control or influence over the content of the webpage; or
The pharmaceutical company has paid for both (i) the right to have 100% of the advertising on the page and (ii) the inclusion of a statement to the effect that it is the sponsor of such page, such as “Sponsored By”.

Thus, merely advertising on a webpage that includes user-generated comments would not impose an obligation on a pharmaceutical company to affirmatively monitor such content.

Conclusion

In conclusion, I want to emphasize the significant opportunity presented by the internet to help facilitate adverse event reporting. HealthCentral and other online health companies can help syndicate tools and information from the FDA across the broad range of online health communities to improve adverse event reporting online. I hope that based on these hearings, the FDA will provide clear, internet-specific guidance to advertisers and online health companies so that the power of the internet can be harnessed to best promote public health.