Today, I attended via webcast the FDA’s hearings on the use of social media to promote medical devices and drugs. The hearings started at 8:00 this morning and I listened uninterrupted until around 3:00, and then off and on after that. The speakers included drug companies (including some that also make cosmetics, such as Johnson & Johnson), medical device manufacturers and suppliers, physicians groups, health-focused websites and bloggers (all sponsored by drugs and medical device companies), industry and advertising trade organizations, public interest and consumer groups, attorneys and social media strategists.

An “individual consumer” is listed as a speaker, and I presume she will speak tomorrow. Each speaker spoke for an allotted period of time (some were allotted a lot more time than others), and the FDA officials present were given a chance to ask questions after each presentation. The FDA representative were fully engaged and asked a lot of good questions on all sides of the issues presented. The hearings will conclude tomorrow but I will not be able to attend. The FDA has promised to make a full transcript publicly available (though it’s not clear whether there will be a charge for them). When it does, I will share the link with you, along with more of my impressions.

While this 2-day round of hearings concerns drugs and medical devices, it is my belief that whatever the FDA does in these areas will form at least some of the basis for what they eventually do where food and cosmetics are concerned. I want to make sure that small and independent businesses are positioned to positively impact the process, and informing ourselves at the hearing stage is the first step in that process. Note that I am not an expert in the drug and medical device field so I am sort of learning as I go. If anything published here is incorrect or requires clarification, I will make sure that happens in a way that fully and fairly informs you in future blog posts.

While a variety of views were expressed today, and there are numerous differences of opinion, there we some consistent themes. Here is a quick wrap-up of my initial impressions.

1. Levels of Corporate Responsibility. Everyone seems to agree that full and complete disclosure and transparency must exist with respect to any promotional content that is created or sponsored (directly or indirectly) by drug and medical device companies (I’ll call them “pharma” for short). From there, the suggested levels of corporate disclosure responsibility differ greatly.

   Some speakers (in particular Diana Zuckerman of National Research Center For Women & Families) suggested that companies should be responsible for content whether or not they actually sponsor it, and whether or not they even actually know about it. Ms. Zuckerman suggested some sort of social media user fee in order to fund FDA regulation in this area. (This was a very scary proposition and I’m keeping a close eye on such suggestions.)

   Other speakers, predictably pharma companies, were less willing to embrace the notion that they should be responsible for third party content over which they have no real control. Non-manufacturer companies like health-focused websites were very concerned that whatever action is taken should not affect their ability to maintain the pharma sponsors that form the backbone of their business models.

2. Wikis. Wikis, online portals that can be edited by anyone, regardless of expertise, were the subject of much discussion. Everyone agreed on the power of wikis, including Google Side Wikis, and most seemed to agree that they present potential problems where drugs and medical devices are concerned because anyone can modify wiki content at any time, and no special expertise is required in order to do so.

   There was also discussion of Wikipedia’s policy to delete promotional material, and how, in practice, that does not always happen. It was clear that the sort of “crowdsourcing” through wikis presents significant concerns as data continues to indicate that consumers rely largely on the Internet to collect health-related information.

   The obvious issues revolve around corporate responsibility for third party content on wikis — what responsibility do companies have to monitor the content? What responsibility do they have to actually force the removal of content that is incorrect? No one had good answers to these questions, but they are issues for pharma, just like they are issues for all businesses large and small.

3. 3 C’s. Rohit Bhargava, Senior Vice President, Digital, Strategy & Planning Group, Ogilvy 360 Digital Influence (who also maintains his own blog here), offered an interesting approach. He suggested a “3 C’s” approach to determine a company’s responsibility for online promotional content.

   (1) Creation: If the company created the content and the content has not been altered by third parties in any way, but instead exists in its original form, the the company is fully responsible for the content.

   (2) Collaboration: If the company worked directly or indirectly with the creator of the content to create the message, the company is responsible for the content and full disclosure and transparency must apply. The question is, of course, what constitutes this “full disclosure.” There is discussion of a “one-click” mechanism that allows people to view the content, and then with “one click,” be taken to an authoritative site with all of the disclosures and risks fully addressed. (Some people like this idea. Consumer groups tend to think it does not go far enough.)

   (3) Compensation: If the company funded creation of the content or somehow compensated the creator of the content, the company is responsible for the message and full disclosure is required. (Again, “what is full disclosure” is the issue.)

   Unless the promotional content fits one of those categories, Bhargava urged, then that company cannot be responsible for that content. While it benefits everyone for companies to correct or even remove misinformation, one cannot expect a business to police the entire Internet, and/or be held responsible for content that business cannot remove or modify themselves. You can read Bhargava’s post about today’s hearings at his Ogilvy 360 blog.

Challenging Issues

These issues are challenging indeed, and this post barely scratches the surface. The hearings this week concern drug and medical device companies specifically, and even though companies participating in those industries are regulated very differently than companies in the food and cosmetics industries, the core questions are very similar. What if third parties publish content about your products or the ingredients used in them, and that information is incorrect or somehow causes harm to someone else? Are you responsible for that under all circumstances?

What if you are? What if you ask the third party to remove the content, but they refuse? Are you still responsible for the content? are you responsible at all if you did not have direct involvement in the creation of the content? Or are you only responsible if you participated or somehow sponsored or supported the creation of the content? same. What disclosure rules should apply?

Is your head spinning? Mine is.

What About Small Businesses?

One thing that bothered me about the hearing today is the the phrase “small business” was never uttered. I know that most drug and medical device firms are not small and independent business owners. But like all federal agencies, the FDA is under Congressional mandate through the Regulatory Flexibility Act to specifically analyze the impact of their actions on small businesses and to seeks the least burdensome means of regulation so that small businesses are no unnecessarily adversely impacted.

It seems to me that the FDA cannot do that on this issue unless it actually hears from small businesses. I think that a small business or an entity representing small business interests would have been a positive addition to today’s hearings. I’m not sure what can or should be done about that where the drug and medical device issues are concerned, but since the food and cosmetics industries are composed of a very large number of tiny businesses, we will have to see what can be done to get a seat at the table when the FDA turns its attention to food and cosmetics.

Remember, if you want to tune in tomorrow morning, you can do so at this link.

Oh! By the way, if you want to purchase a DVD of the proceedings, the price is only $140 at this link. I bet you know what I’ll have to say about that when I get the chance, don’t you?

Question: What do you thing of all of this? Do you have any opinions one way or another? If you tuned in to the hearings, please feel free to fill in what I might have left out.

For as long as I have served small and independent business owners, I have observed how challenging it is to have an impact on public policy that is commensurate with the positive impact we have on our communities and the American economy. I hope to change all of that with the announcement today of Indie Business Advocate.com! The purpose of Indie Business Advocate.com is to engage our customers, our communities, public and private entities, legislators and policy makers with regard to legislation that impacts our ability to serve our customers as we expand our businesses.

(If you are reading this article via email or in an RSS reader and cannot view the video, please click here.) Here is what we must do to maximize the impact of the blog as a trusted and influential tool.

1. Be Informed. We cannot speak persuasively and with confidence about pending legislation unless we first inform ourselves. We must understand the current state of the law, and how the proposed law will affect the status quo? How will it affect individual businesses, and what impact will it have on the affected industry as a whole? Who are the interested parties and stakeholders, including public and private industry trade groups?

   What is the current state of the law? Why is change necessary? How will the proposed legislation accomplish legitimate governmental goals? Will the proposed law affect our ability to serve our customers? If so, how? Can the government accomplish its legitimate goals without without unduly burdening small businesses?

2. Develop Policy Positions and Statements. Once we are informed, both individually and collectively, we can develop strategies to promote positions that accomplish public policy goals without unduly burdening small and independent business owners. We can join forces, one with another, and also collaborate with other public and private trade organizations and consumer groups to create advocacy synergies where possible. As our message takes shape, we can work with as many people as possible to have a positive impact on the process as things move forward.
3. Show Up!! A carefully crafted message means nothing if it ends up collecting dust. Once goals are identified, along with the means to accomplish them, we have to “show up” and articulate them to all interested parties. This means using every means at our disposal to spread the word about our position as we empower others to join our advocacy.

   We must use telephone calls, email messages, email newsletters, faxed letters, blog posts, videos, Tweets, FaceBook updates, LinkedIn and in-person advocacy meetings to circulate our message. If we work together, this blog will help all of us do these things without creating a huge amount of work for any one person.

The Time Has Come!!

Last year, along with 4 member of IBN, I went to Capitol Hill to advocate against passage of the FDA Globalization Act of 2008, which was introduced in April 2008. My colleagues and I informed ourselves about the proposed law, developed the specific messages we wanted to deliver, got on an airplane and flew to Washington, DC to make our voices known. Meanwhile, several individual business owners called and emailed their Congressional representatives to share concerns. Our message was clear, sensible and, most of all, consistent.

The result is that the FDA Globalization Act of 2009, which was introduced in January 2009, contained little to none of the objectionable provisions that were contained in the 2008 proposal. We continue to be very active with respect to the 2009 Act, and we are very pleased with how Congressional staffers have opened their doors to listen, ask questions and respond to our concerns.

While I’m sure our advocacy was only a piece of the puzzle, the fact is that we made a difference.

Our request to share our concerns was granted. We delivered our message, which changed the course of history.

Won’t you join us in building on the progress already made?

Question: What are your biggest concerns as a small and independent business owner? How do you think we can work together to influence legislators and policy makers to enact laws and regulations that protect consumers without unduly decimating small and independent business owners?