Draft Guidance on Unsolicited Requests for Off-Label Information

There has been a good deal of commentary on the recent issuance of a draft guidance by the FDA entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” which was issued by the agency on December 27.

Note that the words “social media” are nowhere in the title.  Yet, as Brian Reid pointed out in a posting today, many of the headlines about this guidance in online commentary regarding its issuance stated that it was an FDA social media guidance.  (See “The FDA and Social Media:  What the Headlines Got Wrong“).  It is actually a guidance that mentions social media, which is welcomed, but not a guidance aimed at addressing the bigger issues at hand, of which there are many.  This is a draft guidance that the agency would probably have issued even if there had been no such thing as social media.

That said, the draft raises some interesting questions.  The primary focus of this guidance is to enunciate ways that medical product can respond to unsolicited requests for off-label information and attempts to provide insight into what is unsolicited versus solicited.  The agency defined unsolicited requests as being “those initiated by persons or entities that are completely independent of the relevant firm.” (emphasis added)

To provide some insight into what that means, the agency gave three examples of unsolicited requests.  In none of the three is the company taking any action at all respecting the passage of data about the off-label use – they are all examples where spontaneous inquiry occurs from a member of the public.

The agency then provides examples of actions by a medical product manufacturer that could be perceived as a solicited request for off-label information.  Note that a solicited request “may be considered evidence of a firm’s intent that a drug or medical device be used for a use other than that specifically approved or cleared by FDA.”  These examples mention some proactive action by a medical product manufacturer such as a sales rep who mentions off-label use, or a speaker presents Pokies off label data at a company6-sponsored event.

But also included as an example are these two:  First – a firm sends out packets of information to known bloggers and encourages them to write about an off label use.  Second – a firm announces results of a study via Twitter and “suggests” that an off-label use of a product is safe and effective.

These two examples raise important questions not made clear by the draft guidance. Does the first example mean that bloggers, and by extension reporters, cannot be briefed by a company regarding data milestones of an approved product being studied for a secondary indication?  Obviously the point of a briefing – or a briefing packet – is to get the reporter or blogger to write about it.  Many reporters are also bloggers.  Has the FDA laid out a new policy here regarding discussion of new data for off-label use by manufacturers?  The second example also lacks clarity.  If the manufacturer sends out a tweet with a link to a publication of new Phase III data published in a well-established medical journal that says “New Phase III data on XYZ drug” – is that enough to suggest that they are promoting an off label use as safe and effective or does there need to be some kind of language that is more promotional in nature?

Completely shutting down a manufacturer’s ability to proactively mention study data published about an off label use may not be what the FDA intends with this guidance, but it may be what a lot of conservatively minded regulatory minds perceive.

In short, the guidance examples leave open the question about whether a manufacturer can take any proactive steps regarding new data on an approved drug when it is related to a not-yet approved condition.  As a guidance, this may be raising more questions than are answered when it comes to the primary focus of the guidance and it certainly needs to be made more clear what exactly is meant by the FDA’s characterization that the unsolicited response must be “completely independent” of company action.

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4 Responses to Draft Guidance on Unsolicited Requests for Off-Label Information

  1. Great points you raise, Mark. I’d also like to see some clarity around other private message request. They mention e-mail and phone calls, but I would think that DMs, Facebook messages to a pharma’s Profile account, and comments queued in a pre-screened blog would qualify as well.
    Disclosure: I work with Brian at WCG.

  2. Brian Reid says:

    Mark — Good catch. I agree that the FDA didn’t intend for this guidance to reflect a tightening of standards around pre-approval or off-label promotion, but the sooner we get clarity, the better.

  3. Pingback: FDA guidance on social media: a draft is not enough! « Science Intelligence and InfoPros

  4. Hi, Mark. Your review of the new guidance is insightful as always. You’ve raised one of many questions that the document leaves on the table. (It certainly doesn’t answer all our questions, but it’s still better than nothing.) My understanding (though its been awhile since I was in PR) was that issuing press releases, tweeting, and using other means to communicate study results was protected under the scientific exchange of information. Perhaps, as you infer, the difference is in whether the tweet itself makes promotional claims or not. Your guess is as good as — no, probably better than — mine on that one. If that’s the case, there are likely many violative tweets floating about the Twittersphere. What’s the answer? Each company, as always, will need to determine its own level of risk tolerance. So we’re kind of back where we started, eh? Thanks for the post!