The FDA’s social media hearing concluded today with a second round of testimony on the challenges surrounding online promotion of health information. The morning session focused on adverse event (AE) reporting, while the afternoon session supplemented yesterday’s discussion of manufacturer accountability, real-time information, corrective information, and use of links. (Our Day 1 summary is available here.) Yesterday’s hearing received significant media coverage and we expect the same for today’s panels.

Following is a top-line overview of common themes from today’s testimony and some of the recommendations put forth.

Challenges and Solutions in Online Adverse Event Reporting

Common Themes and Consensus

Several presenters noted that because of unclear guidance around AEs, companies are turning their heads and not engaging. David Saggio from LehmanMillet said the industry is “paralyzed,” while John Mack of Pharma Marketing News referred to a “see no evil, hear no evil” approach.

Echoing yesterday’s discussion of responsibility, most speakers said it is impossible for the pharmaceutical industry to police the entire Internet for potential AE reports due to the sheer volume of information. PhRMA’s Jeffrey Francer reminded us that current industry guidelines say manufacturers should monitor their own Web sites but not external ones, and that if companies become aware of AEs on any site, they must address them.

HealthCentral’s Chris Schroeder called for greater clarity around the definitions of ownership and sponsorship and posited that advertising on a site does not make a company responsible for reviewing it for AEs. Steven Findlay of Consumers Union held that while companies can’t be accountable for the entire Web, they should take on some degree of voluntary monitoring. And Heartbeat Digital’s Bill Drummy said once companies begin monitoring, they have a responsibility to correct misinformation and report AEs.

Nearly everyone agreed that a major challenge in online AE reporting is that only a small fraction of events discussed online qualify as reportable. (A reportable AE must have an identifiable patient, reporter, event, and drug. Learn more from our blog.) Several speakers quoted Nielsen Online’s figure that only 1 in 500 online AEs is reportable. So the question is: How far are companies expected to go to obtain the information that would make AEs reportable? And would this search violate patient privacy—the very thing that attracts so many people to the Internet? According to WEGO Health’s testimony, about half of health activists say companies should respect people’s privacy and not probe for AE information, but about half also say that every effort should be made to track down this information.

Several recommendations were made by presenters, and a detailed breakdown is available in the full report.

Additional Testimony on First Four Topics

This afternoon’s testimony largely mirrored yesterday’s themes. Speakers continued to note that the pharmaceutical industry needs adaptable Internet-specific guidelines as soon as possible.

Highlights from the afternoon session include (a greater summary is available in the report):

• The downsides of manufacturers correcting inaccurate information online;
  
• The challenges of inaccuracies on third-party sites and handling user-generated content;
  
• How manufacturers could engage in social media; and
  
• The value of direct communication with physicians.

What Happens Now?

Unlike other FDA hearings, this one was not meant to end with an immediate vote or decision. In his closing statement, the FDA’s Thomas Abrams admitted that the agency has "much work to do" to understand the interactive medium. He also noted that the FDA will accept written testimony on these topics through February 2010. The agency will then reflect on the considerations and recommendations it received and begin to develop guidelines based on this testimony. Several sources have predicted that guidance will not be available until at least late next year.

In the next few days, Edelman will assess the extensive testimony we heard this week as well as the social and traditional media coverage surrounding it. We will provide an in-depth report next week that both summarizes and provides perspective on key topics. We hope you will continue to follow our Digital Health team on Twitter (@EmilyDownward, @EngageInHealth, and @RickMurray) and visit our blog at www.engageinhealth.com.