After five years in the making, the FDA is on a roll. Following the publication of the previous draft guidance on the use of social media for “post-marketing submissions for post marketing submissions of interactive promotional media“, the agency has published two new guidances of conduct of medical device and pharma companies in social media.
The first seems easier to understand and implement than the second.
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Draft Guidance I: Correcting independent third-party misinformation about prescription drugs and medical devices
Imagine the following: You work as a sales representative in a medical device company. It has come to your attention that a blogger wrote a post that contains inaccurate information about your medical device. On the same day, you learn of a patient that has shared personal experiences with your device on a forum and misinformed other patients about the device’s use. You believe that the way that both these stories are represented may be harmful to the public health. You start typing away at your answer, informing the blogger and forum members of their mistakes. FDA guidance suggests that you should stop first and ask yourself: is it worth your while?
The FDA maintains that you have no obligation to correct any information published by a third party who is not under the firm’s control or influence. This is regardless of whether the firm owns or operates the platform on which the communication appears.
The FDA leaves this to the discretion of the pharma company or medical devices company. If the company chooses to engage in the correction of misinformation, it needs to adhere to certain approaches outlined in the guidance – for instance it cannot only correct negative misinformation written about the medical device while ignoring an overstatement of the benefits of the product.
Download complete draft FDA social media guidance on Correcting Independent Third-Party Misinformation about Prescription Drugs and Medical Devices.
Draft Guidance II: Internet/social media platforms with character space limitations
This FDA draft guidance is more comprehensive than the first and seems more complicated to execute. The guidance describes the FDA’s current thinking about how medical devices and drug manufacturers and marketers should present benefit and risk information of promotional materials in channels that have “character space limitations” (mainly Twitter, and “sponsored links” on search engines such as Google). The guidance does not include platforms such as Facebook and YouTube where there are no space limitations.
The main takeaway: Risk information must appear alongside risk information. Both must be presented in the same message. The FDA clearly states that having risk information on only a Twitter cover photo is insufficient and that main risk information should be included in the short message as well. If a medical company concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message. To many companies, this will be the case. To make matters more complicated, a link should be should be supplied that brings visitors to a page that is solely dedicated to risk information.
The guidance on how promotional materials should be prepared and presented goes on at length in its recommendation – using the example of a fictional drug they call NoFocus (And some people say that the FDA has no humor….).
The use of so many examples shows how complex this field is and the extent to which the FDA does not have a clear grasp of the way it should be managed.
Download complete draft FDA social media guidance on Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
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