FDA Wakes Up to Social Media’s Ability to Monitor Drug Adverse Events

March 05 02:29 2014 Print This Article

Alec Gaffney reports that a recent FDA Notice of Solicitation (#1127679) calls for a “contractor capable of providing it with social media monitoring services capable of analyzing consumer sentiment and social media ‘buzz'” (read “Once Again, FDA Seeks to Leverage Social Media to Uncover Adverse Events and Public Sentiment“).”

Specifically, one objective is to provide FDA with “surveillance through social media listening for early detection of adverse events.”

The scope of work includes social media buzz reports, a social media dashboard, and quarterly surveillance reports related to specific product classes.

Instead of passive listening and creating interesting but useless “dashboards” and reports, why doesn’t the FDA and/or the American pharmaceutical industry follow the lead of the Association of the British Pharmaceutical Industry (ABPI) and advocate a more proactive approach to using technology to help consumers report adverse events?

In 2011, ABPI recommended that company owned sites “be designed to facilitate the pharmacovigilance process” through use of “free text fields” and access to “internal/external reporting based tools which allow users to report suspected adverse drug reactions” (read “The British Pharmaceutical Industry Issues Social Media Guidance for Adverse Event Reporting“).

The ABPI also issued guidance that addressed three different ways that pharmaceutical companies may learn of adverse events (AEs) through social media:

1. “Listening in” — Monitoring social media sites allows a company to “listen to” or “see” what the public are discussing, saying or sharing about the company itself, diseases, conditions, and treatment options.
2. “Giving out” — Many social media sites allow companies to initiate one-way communications to share important messages with the public, where interactive dialogue is not permitted or practical.
3. “Engaging with” — Engaging, exchanging and participating in interactive communication with the public. This type of activity is performed in both company and non-company sponsored sites. I’m not sure if any pharma company has acted upon ABPI’a recommendation, however. It’s all self-regulated. That’s why there should be a law requiring drug companies to implement better adverse event reporting features on their web sites and FDA should follow ABPI’s lead and provide guidance on how companies can monitor social media.

One tool that I recommended is an Adverse Event Reporting Widget (read “Using Social Media in a Crisis: Distribute a Product Safety Widget Is One Idea“; find a mockup of such a widget here).

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Article contributed by PharmaGuy courtesy of PharmaMarketing Blog
February 27, 2014