It’s almost that time. One more week until the FDA hearings that everyone has demanding for more than a year. As a refresher, on November 12-13, the FDA is holding a public hearing on the use of social media by pharma and medical device companies (and others). Officially, the title of the hearing is: Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (Document ID FDA-2009-N-0441-0001).

I recently posted the agenda for the meeting, but it has been updated. You can download the new agenda here:

Updated Agenda for FDA Social Communications Hearing (710 downloads)

(By the way, for the latest and greatest on all things FDA social media hearing, just go to the #FDASM site created by Fabio Gratton.)

I was given the privilege of being one the people who will have a chance to speak at this meeting. The meeting has been broken up into two parts. November 12 and the afternoon of November 13 will tackle the first four questions in the FDA’s announcement. The fifth question in the announcement gets the entire morning of November 13. This question deals with the handling of adverse events (AEs), which even the FDA recognizes as the major stumbling block for companies in dealing with social media.

I will, in fact, be speaking twice. The first will be covering an issue I see with adverse event reporting. The second deals with Question 3 of the FDA’s hearing request (go here to see all the questions and specifics).

Question 3 was this: “What parameters should apply to the posting of corrective information on Web sites controlled by third parties?”

Since the FDA wanted to have everything in advance so they could print it all out for their committee members (why, I don’t know), we needed to turn our presentations into the FDA a week in advance. That was yesterday. Like my friend Wendy Blackburn (also speaking at the hearing) noted while working on her presentation, I too felt like I was working on a critical final paper back in college. Not sure why, as I’m constantly creating presentation it seems (working on one right now, in fact), but being the FDA added a bit of intensity and certainly made me focus a bit more. It’s a big opportunity that the FDA has given everyone here and I am putting a lot behind my efforts, as I’m sure the other speakers are as well.

Since all of the testimony from the meeting is public and will be posted in advance of the meeting, I wanted to give my readers a sneak preview of my testimony. You can download the POWERPoint of each presentation below. It includes my rough “script” that I’ll be using as well. That should ensure the slides make some sense as you review them. They might not without the notes. Just a fair warning.

For Question 3, my presentation focuses on answering this question: “Can a LACK of regulations improve the quality of healthcare information available online?” Sounds odd, but think about it for a minute. The current rules, actually the lack of them, is making many companies reluctant to participate in discussions online. What is happening in many of these discussions is people are sharing inaccurate and sometimes dangerous medical advice with one another. Not on purpose, but that’s the net result. Pharma companies would welcome the chance to correct some of this misinformation (in an appropriate manner), but feel they can’t under the current rules. My question is this: if the FDA is charged with protecting the public health, is allowing companies to fix incorrect medical information online more dangerous than doing nothing? I’d argue that the “risk” of having companies attempt to correct this information is FAR less than the risk posed by the inaccurate information itself.

I’ve also proposed an approach for how pharma companies can be allowed to engage in these discussions, while still allowing the FDA to retain some control. I owe a lot of the thinking behind this idea to Dr. Val Jones, CEO of Better Health. She talked with me for about an hour the day before all of this was due and had some great ideas on how to make this all work. It wouldn’t have come together as well as I think it has without her help. If you haven’t had a chance to work with Val (or Dr. Val, as most people call her), go find her. She’ll likely be able to help with whatever you’re working on.

Here is the presentation I’ll be doing for Question 3: FDA Social Media Hearings Testimony (1058 downloads)

For Question 5, regarding adverse events, my presentation is focused on asking the FDA to clarify precisely what is required for an adverse event to be reportable. We all know you must collect four pieces of information, but how far does a company have to go to find that information and what qualifies as a “good enough” answer to the question of “what is the reporter’s name?” for example. Is, say, a Twitter handle good enough or do you need the person’s full name? When the rules for collecting adverse events were created, events were almost exclusively collected by doctors and it was all done via paper. The doctor knew all the people involved including real names and could get all the other details as well simply by asking some questions. Today, with the Internet and specifically social media, events are talked about all the time and they rarely rise to the level of “reportable” because there isn’t someone there to immediately ask follow up questions about an event talked about in a forum. This makes it very difficult to collect that information. So, how far do pharma companies have to go to find it? Are we going to turn them into private investigators running around trying to figure out people’s real names? That doesn’t make sense to me.

Here is the presentation I’ll be doing regarding adverse events: FDA Social Media Hearings Testimony Adverse Events Specific (1040 downloads)

I’d welcome any feedback you have. Please leave it in the comments. I’d love to hear what you think and to have some additional thoughts heading into the meeting next week.

Wish me luck.

Possibly related posts (auto-generated):

1. FDA Public Hearing on Social Media Agenda and Speaker List Released
2. Three Things I Learned at the FDA Social Media Hearings and Three I Wish I Had
3. 2010 Dose of Digital Sneak Preview