After attending last week's FDA public hearing on the internet and social media, two things stood out in my mind:
- Pharmaceutical companies will not be taking "risks" or investing in social media until there are clear, identifiable guidelines from the FDA - as of now, pharma is living in a state of fear of social media
- The FDA knows there is a need for implementing guidelines for pharma, but it seems they really don't know where to begin...they are looking for strategic recommendations from stakeholders - they've never been in this space before and are honestly looking for help on how to best approach it
Whereas day 1 of the hearing focused solely on Questions 1-4, the morning of the second day was dedicated to Question 5 - Internet adverse event reporting (for a quick re-cap of the first day of the hearing, check out my blog post "This is the Super Bowl of Part 15 Hearings"). If you are familiar with the pharmaceutical industry, you are well aware that adverse event reporting is a very sensitive subject, so I was particularly interested to hear the speaker presentations. I was actually excited to hear the audience reactions to the recommendations.
The speakers focused on two themes related to internet adverse event reporting:
- How can we classify an adverse event on social media?
- How can we make things easier so people partake in reporting adverse events?
Kim Witczak, the only individual consumer to present at the public hearing, stated that the internet is an "untapped resource for gathering adverse events." Kim suggested that MedWatch needs to be more consumer-friendly, an idea that others, like Steve Findlay from the Consumers Union, also support. During his presentation, Steve went on to say that most people don't even know they can report an adverse experience to the FDA - so wait...how is this helping anyone? He suggested that the FDA require all pharmaceutical Web sites (owned or controlled) to display a link to the MedWatch page. There should be clear indication regarding when, where and how to report an adverse event. To see how NOT consumer-friendly the FDA form is now, take a look at the 12 page document.
Shaleen Gupta, Semantelli Corporation, discussed how the four criteria for reporting an adverse event do not accommodate social media. The basis of certain social media sites is anonymity...so how can we justify "Animals4evr" as an "identifiable patient?" Jonathan Richman from Bridge Worldwide, and blogger of Dose of Digital, recommends an entirely new system of reporting to meet the social media "language." In today's social media driven society, why can't Animals4evr classify as a name? Perhaps the 3500 form can read "reporter handle" instead of "name."
Rohit Bhargava, Ogilvy's 360 Digital Influence, stated that brands should be responsible for reporting adverse events only if all reportability and identifiability criteria are met without any additional follow up required from the brand. This addresses the concern of where the "invasion of privacy" line is drawn.
A few speakers, notably John Mack from Pharma Marketing News, introduced the idea of a widget to report adverse events. The widget would be included on all sites drug- or pharmaceutical-related.
Websites would serve three main functions:
- Educate consumers about the side effects of drugs
- Provide guidance to consumers for discussing adverse experience with their doctor
- Give consumers an easy, direct method for reporting AEs online
It is clear that some sort of direction needs to be provided to the pharmaceutical industry by the FDA. Ironically enough, by the time the FDA establishes any guidelines we'll probably need another public hearing to discuss something else. Anyone willing to bet that Google SideWiki will have a hearing of its own? Maybe we'll be shocked and the FDA will surprise us all with guidelines for Christmas next year. Until then, check out the public docket and fdasm.com for updates.
Tags: FDA, FDASM, Social media
Nice post Melissa - I think the AE widget is a strong idea, because it gives FDA an opportunity to collect information (consistently) and at the same time educate patients about the process. A few months ago it would have seemed like a pipe dream. However after the launch of FDA's Twitter feed, and the hearings, I believe everything is on the table.
Jeff Greene
HealthEd Group