Findings from Questions on FDA Guidance Regarding Responding to Unsolicited Off-Label Requests (Part II)

Questions to ask

As a follow up to the questions I submitted to FDA regarding the recent Guidance on providing Off-Label responses to unsolicited requests online, I had the pleasure of speaking with Jean-Ah Kang at DDMAC and getting her anecdotal feedback.  Please note, the commentary below is my interpretation of the conversation and in no way a transcript.  This interpretation is mine alone.

Here’s the long and the short of it: Companies need to ask themselves what is their intent – it’s impossible to highlight every single scenario.  Some of the tactics and70-220 channels are novel, but the policy position has not changed.  This guidance is not designed to interfere with practice of medicine – physicians can do what they want, but Pharmaceutical companies can’t promote off label to their own benefit.

Global Websites & Wikis

Q: How do we handle global websites such as a corporate Facebook page where some responses may be off-label in the US but not for other countries?

A: We know that companies can’t control where the conversation is coming from.  However, FDA is only US focused. If there is concern about clarifying for the user that they are on a US site versus an ex-US site, segmentation in the form of a pop-up screen would help.  The important thing is identifying responsibility of each party (US or ex-US for a Global company.  Provide the correct segmented contact information in order to allow for responsible follow up.  Also, its important to make sure that the comment is about your product and not someone else’s.

Responding Publicly and Privately to Unsolicited Question

Q: Could you provide clarification on the term “choose” in regards to a company’s responsibility to communicate directly to off-label unsolicited requests
SU0-223-CN(i.e. does this mean that a company can choose not to respond)?

A: Any company can choose not to respond.  That said, trying to ignore it is not good.  Up to the company if they want to respond but you need to keep in mind whether you are trying to do the right thing or just justifying your actions.

Q: What Guidances, if any, are there on which unsolicited responses we choose to or not to respond to on sites outside of a pharmaceutical company’s ownership and control?  By responding, are we then assuming responsibility for responding in perpetuity?  If we respond to a request on one website but not another would that be considered cherry picking?

A: Accountability of information is important to FDA and is one of concepts that is one of the 6 areas of information that will likely be focused on for the coming guidances, along with correcting information.  No specific guidance on accountability will be developed, rather, it will be inherent in all of the guidances.  If only responding to positive information and not negative, then there will be attention on the company. Think carefully about your actions before you do it!  Make choices in line with what your company is comfortable with.

Providing Information to Patients & Consumers

Q: Can patients and consumers receive the same information as what we would provide an HCP?

A: There is nothing wrong with giving HCP information to Consumers – consumers can be very savvy.  That said, the information should be in a language that they can understand.  In keeping with this, it’s a best practice to make sure that translations and adaptations do go through DDMAC.  See the suggestion about PPI in section 6 of the draft guidance.  If you are following the spirit of the guidance then it should be okay.

Q: Is a summary of a reprint allowable in addition to the full reprint?

A: Could be concern about that kind of request – if the company summarizes and there is any implied bias or promotion. FDA is not saying that its not allowed, per say, and they are not prohibiting information – they want companies to respond directly.  In regards to whether it’s necessary to submit responses to the FDA to determine if this kind of summary is promotional in nature, again it’s not necessary, because it just shouldn’t be promotional.  It comes down to the data and letting the questioner make the final decision.  It’s important to provide the positive as well as the negative.  Summarizing could, however, present bias and should be approached with caution.

Documentation Retention

Q: Is there any guidance around how long information needs to be retained?

A: No specific recommendation – would welcome feedback for guidance.

Q: What are the requirements for logging and reporting these unsolicited Off-Label interactions (i.e. filing 2253)?

A: No requirement for logging and reporting these conversations (i.e. 2253) because there is no promotion.

Definition of Off-label

Q: Is information that is consistent with approved use, but not contained in the labeling considered “off-label” for the purposes of the draft guidance?

A: Substantial evidence criteria – the more important concept is around being consistent with the approved use.  Even if a concept is not mentioned in PI, but consistent with use, its still on label.  Data from research stages, patient populations, accelerated approval claiming long term survival benefits would be considered off-label.  It doesn’t have to be written in stone with what is in the labeling.  That brings up a key point: its important to have communication between divisions – labeling is not always working with medical communications handling off label requests. Medical communications needs to know the history of communication with FDA on labeling to make sure that the communication is not promotional.  Therefore, the history of labeling can be very useful.

Q: Labeling and requirements around handling of questions that are nuanced and could relate to the trials supporting the labeling.

A: The spirit of the guidance is that if a company follows the guidance than they are in a safe harbor.  They are not necessarily in trouble if they don’t follow every single one.  The FDA does not randomly pick on a company, they do their homework.  Answering off label questions is not going to be the thing that will land a company in trouble, whereas the intent is to promote off label will.  Clarifications about a study design can’t necessarily be considered off label.  That said, if you answer a question and end up in an off label discussion, then will be important to keep things on track.

Hope this was helpful.  Jean-Ah did note that they have not received many comments or recommendations for the Guidance and they would appreciate it.  Though the comments period has passed, please consider sending in your thoughts – it can only help… Good luck and godspeed!

Zoe Dunn
Zoe Dunn, President and CEO of Hale Advisors, is a digital marketing and communications specialist with over twenty years of experience in the field. She has extensive experience in both the agency and commercial marketing side of the pharmaceutical, medical devices, and biotech industries.

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