Pharmas responsibilities for monitoring and reporting on the Internet
In the 3rd of a series of related articles, eyeforpharma and Intouch Solutions blogger Wendy Blackburn provides insights from the Nov. 12-13 FDA hearings
By on Dec 15, 2009In the 3rd of a series of related articles, eyeforpharma and Intouch Solutions blogger Wendy Blackburn provides insights from the Nov. 12-13 FDA hearings
on the use of the Internet and social media by FDA-regulated industries.
On November 12-13 in Washington D.C., members of the FDA, pharmaceutical and medical device industries, and other stakeholders convened to address the marketing of products via Internet and social media. This article will take a closer look at the discussion around companies responsibility for monitoring, correcting, and reporting information found on the Internet, including adverse events. Also, now that the hearing is over, the videos and transcripts are posted, and the discussion is dying down whats next?
What information and communications should pharmaceutical and device companies be addressing online? Speakers at the FDA hearing addressed this topic when providing their opinions on two specific questions: For what online communications are manufacturers, packers, or distributors accountable? What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
Many speakers felt companies should be held accountable only for content over which they have direct control. Direct control may include posting the information themselves, paying for it to be posted, or other levels of influence. Allan Coukell of the Pew Prescription Project repeated a common theme: With regard to question one, we suggest manufacturers are responsible for any communication they create or cause to be created, and that extends to communications by third parties where there is any quid pro quo or of any facts or control over the content. Whatever the type of control, most agreed that disclosure of a companys involvement is critical.
Should pharmaceutical and medical device companies be held responsible for monitoring the entire Web? Most felt this was too much to ask and nearly impossible to carry out. However, Bill Drummy of Heartbeat Digital took issue with the whole notion that we can't possibly police everything being said about drug X. Yes, we can. Software actually makes it very doable to do it.
Adverse event (AE, or side effect) reporting was such a hot topic that a whole half-day (the morning of November 13th) was devoted to question #5, Questions specific to Internet adverse event reporting. As background, currently the FDA requires that adverse events be reported if they meet these four criteria: an identifiable patient, an identifiable reporter of the event, a specific medication mentioned by brand name, an adverse event mentioned.
Because AE mentions are often anonymous, the discussion centered around the fact that only a small amount of AEs on the Internet meet the above four criteria. Nielson Buzzmetrics Melissa Davies, who presented her oft-quoted data that only 1 in 500 AEs on the Internet is reportable, underscored this. (See her presentation here.) Less than one percent (4) of 500 messages reviewed mentioned an AE at all, and only one of those messages was deemed reportable. Buzzmetrics analysts can typically review and score 100 messages in a day. Around 80,000 healthcare-related messages are posted on the Internet daily.
While some speakers argued that companies should do whatever it takes to follow up on an AE mention, Bob Brooks of WEGO Health presented data that patients might be less than thrilled with that. And HealthCentrals Chris Schroeder asked for clarity around definitions of ownership and sponsorship, arguing that advertising on a site should not make that company responsible for any AEs that appear on the site. Most felt it was important to let consumers know they can and should report AEs. Adding to the patient perspective, consumer advocate Kim Witczak called for increased AE monitoring and reporting and increased visibility of safety information, stating, The best consumer is an informed consumer.
What were proposed solutions to these issues? Several suggested improvements to and broader visibility of the current MedWatch program. Diana Zuckerman of the National Research Center for Women and Families and Jamie Heywood of PatientsLikeMe felt the current MedWatch Web site was complicated, and suggested that a large percentage of AEs likely go unreported. An AE widget that would live on various social media and industry sites was also suggested.
More than a month later, activity around the hearing continues. Especially within the social media space, stakeholders are discussing, watching, and waiting to see when and if FDA guidance will come, and what it will mean to them. The two days represented a very concentrated forum for the FDA to hear from stakeholders in the form of verbal testimony. However, the FDA is still accepting written comments until February 28, 2010. Some say the written submission will have even greater impact than the two-day verbal hearings. See the official notice from the FDA for details on how to submit comments.
So, when can the pharmaceutical industry expect to receive guidance from the FDA? Paul Loebach, project manager, DDMAC, was quoted at the e-Patient Connections conference saying that industry can expect guidance by the end of 2010 as a good estimate. That timeline surprised some, but also may indicate the FDA may have draft guidance in the works. Whatever the timing, the industry will be waiting with baited breath. By holding the hearing, the FDA has started something. And while we dont know exactly what to expect as the outcome of the initiative, we can count on this: This is only the beginning.