On Dec 27 the FDA released guidance to help pharmaceutical firms handle unsolicited requests for off-label information. This document caused quite a stir in the digital pharma marketing world because it deals directly with social media (called “emerging electronic media”) as it relates to the main topic.
Here is a summary of what you will find in the document:
- Acknowledgement that social media is used by both patients and industry
- Unsolicited requests divided into Public and Non-public
- Restatement that industry cannot “tool the user” to violate the regulations by providing easy ways or prompting to discuss off-label uses
- Formalizing of the industry standards where:
- The response is custom and limited to the question but the risk information is comprehensive
- The response comes from the medical information group
- Responses should be scientific in nature – this is a recognition by the FDA that e-Patients can absorb this information
- Marketing is not involved
- The package requirements that dictate the current thick documents that are used as responses
As for social media, coined “emerging electronic media” by the FDA, there is the following specific guidance:
- Industry can answer an unsolicited request found on a public channel, but only if its drug is mentioned by name
- Industry can respond publically with information on how to direct an off-label question to the right contact
- Industry cannot answer a public request in a public way
- The individuals responding on the channel must badge themselves as being employed by the drug manufacturing firm
- Responses must be low-key and non-promotional
What Does this Mean for Pharma?
Generally, these guidelines reinforce the unwritten rules that pharma companies are already following. Specifically, companies need to be careful of promoting the idea of discussing off-label topics or spurring questions by having that information inferred from patient testimonials, social share tools, or other supplied information.
One Important Question Remains
What will happen if an e-Patient collects off-label information on a drug from the manufacturer and then turns around and posts that information on the same social media site where the initial request was made?
Our opinion is that, as long as this posting was not prompted or suggested by the drug manufacturer, then the FDA will not hold them responsible for that activity.