In my first post I addressed, “FDA communication regulations,” as being a deterrent for pharmaceutical companies engaging on social media outlets like Facebook and Twitter. One of these guidelines is Adverse Event (AE) reporting. Here are the basic AE facts:
- The FDA defines an Adverse Event as, “any undesirable experience associated with the use of a medical product in a patient.”
- The FDA’s Adverse Event Reporting System (AERS) is the digital database for the post-marketing safety surveillance program of all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products.
- Adverse event information should be reported to the FDA if the drug company has knowledge of these four basic elements:
- An identifiable patient
- An identifiable person reporting the event
- A suspect drug or biological product
- An adverse experience or fatal outcome suspected to be due to the suspect drug or product
Though these four basic characteristics are outlined, the FDA lacks specific guidance on the subject of Social Media engagement. The most recent FDA draft guidance on responding to unsolicited requests for off-label information mentions social media, but it still does not address the handling of adverse events reported on social media sites (Drug Safety Alliance, January 2012).
It it interesting to watch how different pharma companies are currently addressing this without specific guidelines from the FDA. I’d like to take a look at Merck’s Facebook Timeline Homepage, (which I think is beautifully done) where the company has taken a direct approach to managing AE reporting by clearly drawing attention to policies for its Timeline users (see the red box below).
The “Adverse Event Reporting” tab encourages users to report their AEs to the FDA hotline, providing users an outlet to discuss their AEs while also providing an example of the company’s obligations to the FDA.
“In order to monitor the safety of Merck products, should any of your comments mention an adverse event to a Merck product, we encourage you to report this to Merck’s National Service center at 1.800.672.6372. We may be required to contact you for further information. You may also report any adverse event directly to your healthcare provider or to the U.S. Food and Drug Administration (FDA)” -Merck Facebook Timeline
Merck then expands its recommendation of reporting AE’s to a specific policy directly asking users to refrain from mentioning Merck products on its Timeline. It acknowledges open communication on social media, but again cautions that it will act on its own legal obligations if necessary.
“Merck respects the rights of individuals using social media to voice their views and opinions. However, within our social media channels, we reserve the right to remove comments that are considered inappropriate, off-topic, abusive, or being used to promote and solicit for third-party sites, initiatives or products. We ask that you please respect the following guidelines for our page:
- Please refrain from mentioning Merck products or products from other companies. We reserve the right to remove any comments that reference a product.
- Comments or posts that are factually inaccurate or misleading, are spam, inappropriate, violate another’s copyright or intellectual property, use profanity or are defamatory will be deleted.” -Merck Facebook Timeline
So, do I think that this is an effective engagement tactic? I suppose the answer is not that simple. Let’s break it down.
- Pro: This tactic communicates openly and honestly with the company’s Facebook users about its obligations. Honesty and transparency are essential to social media communication.
- Con: I also think that any attempt to control user content in social media rather defeats the purpose of the platform. In this instance, this tactic may inadvertently dissuade some users from talking on the company’s Timeline at all as it will remove inappropriate content. Isn’t responding effectively to dissenting voices the best way to gain credibility? Visibly removing negative voices can remove some company credibility with them by censoring in lieu of response.
- Pro: On the other hand, however, I’m aware of the mire the company will be left forging when it is inundated with posts about AEs that it is required to report. This tactic does actively manage risk.
What do you think readers? Does this tactic turn you off? Do you think its admirable and courageous? I would love to hear your thoughts!