Friday, November 13, 2009 HF Exclusive: From the Floor of the FDA Social Media Hearing

To expand on our midday post, the Ruder Finn senior staff provides another look at the conversations surrounding adverse events reporting at today’s FDA public hearing on the use of social media by the pharmaceutical industry:

While we discussed the potential pitfalls and challenges that lie ahead in adapting the FDA’s standing adverse events (AEs) reporting guidelines to an online venue, at today’s hearing we also heard about some of the successes of AE reporting in social media communities as well as some recommendations for improving upon existing protocols for reporting – especially for patients.

Most notably, James Allen Heywood, co-Founder, chairman, PatientsLikeMe.com, discussed the benefits, and lack of major repercussions, of AE reporting by the users of his site. As he explained, because the users of his site can see proactive sharing of their own potential AEs as providing tangible returns (i.e., comparing their experiences to the experiences of other users, utilizing the group as a support system), they are more willing to share personal information in this space and as a result, get the most out of the online community.

Yet some feel that effective discussion of online AE reporting is putting the horse before the cart – specifically, before the FDA is able to adapt the current AE reporting guidelines to be more user-friendly in an online setting.

Known as MedWatch, the current AE reporting method has been criticized as being unwieldy and inefficient, especially for patients. Zen Chu, founder, Accelerated Medical Ventures, remarked that Medwatch needs to be simplified, syndicated and embedded across the Web suggesting a commonly noted potential solution whereby industry and social media sites alike employ a basic widget to report AEs.

Almost uniformly Industry presenters also noted that while physicians were more saavy in interpreting and determining accuracy of medical information online, patients needed clear tools to help them assess risk information and stressed the need to simplify the language used in doing so. Providing the full PI is not something that ultimately helps patients make informed decisions and may in fact lead to them ignoring this information altogether.

Interestingly, it was mentioned that although much of the pharmaceutical industry’s trepidation about venturing into the social media space revolves around uncertainty about their requirements in AE reporting, the reality is that actual mentions of AEs online are extremely limited.

Patients expect that industry will be involved in responsibly informing them about risk information and correcting misinformation from unreliable sources. To do so, industry has to get involved, engage in social media and join the discussion – not just push out static content.

To let your voice be heard about the use of social media by the pharmaceutical industry, the FDA will be accepting written or electronic comments until February 28, 2010.

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Submit electronic comments, identified with docket number FDA-2009-N-0441, to www.regulations.gov.


Filed under: Drugs, FDA  by admin at 6:22 pm 11.13.09 Add Comment Keywords: ,