As 2011 came to a close, the U.S. Food and Drug Administration released draft guidance on responding to unsolicited requests for off-label information, which included guidance on how to respond to requests made online. The draft guidance reiterates past guidance and compels pharmaceutical and medical device companies to adhere to existing federal regulations governing how the companies handle off-label communications.
As marketers, we must understand the ramifications of this latest draft guidance, and be clear about what it is and is not addressing. Some key points to be aware of:
- The guidance issued does not change or otherwise impact regulations. Guidance may assist us in better understanding regulations and their intent, but this is very black-and-white. Ask your nearest and friendly pharma/medical device attorney, guidance is not regulation.
- The document has been called by many “draft social media guidance” – it is not and does little to address greater social media use. While it does recommend how social media should be used in an off-label context, the overwhelming majority of pharma/medical device companies engaging in social media already adhere to or go beyond the guidance as it’s put forth (i.e., follow regulations).
- Pharma/medical device companies already have systems in place to deal with requests for information on off-label uses of approved products. This guidance won’t change that. If anything, it should reinforce for us that social media can be used in the context of existing systems as long as we adhere to federal regulations.
- Extrapolating this guidance to additional uses of social media in the pharma and medical device industries should be done with the greatest care. The guidance is not a free pass. It’s a solid reinforcement of past FDA direction related to off-label communications, but it does not address deeper on-label communications via social media.
- Companies must continue to be vigilant with regard to any communications that discuss off-label uses of approved products. There remains the need to exclude any promotion of off-label uses from all communications on behalf of pharma and medical device companies. This has not changed.
One of the key take-aways for pharmaceutical and medical device companies engaging in social media, this draft guidance underscores the need for diligent monitoring and management of all social channels. Whether by internal resources or via agency partners, a monitoring and management program tied into a company’s already existing quality and customer response programs can mitigate issues before they arise.
While the intent of this guidance may be debated for some time to come, when it comes to content related to social media within the draft guidance, the FDA is clear in its language:
“This draft guidance provides FDA’s recommendations to firms wishing to respond to unsolicited requests for off-label information, including both requests made directly and privately to firms and requests made in public forums, including through emerging electronic media.”
The mention of “emerging electronic media” (EEM) does give the feel of social media guidance if we equate Twitter, Facebook YouTube and the like as EEM. But the key phrase in the sentence is in the subject: these are recommendations for companies wishing to respond to unsolicited requests for off-label information. All channels are covered: direct contact (most likely by sales representatives in the field), and other channels (electronic media included) covered by labeling and advertising regulations.
The draft guidance is one of the first from FDA to acknowledge the use of EEM as a means to respond to inquiries. Along with this acknowledgement, the most salient concern mentioned in the FDA document is the ability for information to be “broadcast” via online means, rather than in the recommended one-to-one communication outlined by the agency:
“…Because product information posted on websites and other public electronic forums is likely to be available to a broad audience and for an indefinite period of time, FDA is concerned that firms may post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating unapproved or uncleared use information about FDA-regulated medical products to individuals who have not requested such information. In this circumstance, communications to persons who have not requested information may promote a product for a use or condition for which FDA has not approved or cleared. FDA is also concerned about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available).”
Common sense and continued adherence to federal regulations are key when determining why, how and when companies respond to requests for information on off-label uses of approved products. Social media can and should be a part of the communications mix. However, true guidance comes from understanding existing regulations.
Image credit: JFCherry
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