Selling Clinical Practice Advice

SSchoepel

Involved In Discussions
#1
Either I'm not searching for the right terminology or this isn't an issue, but I'd like to check the Elsmar brain-trust.

I have been asked to review a large document created by our medical device company on how to set up a certain type of screening program within a clinic. From what I've been told we are going to sell this document/advice on how to set up the program. The document contains a few little spots where our product is referenced (like "Product X can help track this") but it's not heavy-handed. It is basically a very long white paper that covers how to set up your administrative staff, to the type of scan (even to say the level of mGy), to pricing/cost for the protocol. It does contain a ton of references and states it was created per some ACR practice guidelines. So that's what it is in a nutshell.

Where I'm concerned is that I've been told it's going to be sold as an offering with/along side our product. Our product is a radiology PACS. It's not off-label use since it's 95% information outside of the use of a PACS within the whole cycle and does not recommend anything outside of the intended use of our product. However, it's still 95% outside of the scope of our product, though we have an expert in the clinical practice as part of our company. Are there regulations or guidance documents on what else you can "sell" or offer as part of your company offering? I just want to be sure I'm not missing some consideration.
 
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Watchcat

Trusted Information Resource
#2
I have been asked to review a large document created by our medical device company on how to set up a certain type of screening program within a clinic. From what I've been told we are going to sell this document/advice on how to set up the program.
What do you mean by "our medical device company"? Is it a company that "we" own? Who is "we"? Your company? Is this the same "we" that is going to sell the document? If your company isn't a medical device company, what kind of company is it?

Please define:
mGy
ACR
PACS
whole cycle

It's not off-label use since it's 95% information outside of the use of a PACS within the whole cycle and does not recommend anything outside of the intended use of our product. However, it's still 95% outside of the scope of our product
Please clarify:
How can it not recommend anything outside of the intended use of your product and still be 95% outside of the "scope" of your product?Perhaps it would be helpful if you also defined "scope" as you are using it to refer to your product.
 

SSchoepel

Involved In Discussions
#3
What do you mean by "our medical device company"? Is it a company that "we" own? Who is "we"? Your company? Is this the same "we" that is going to sell the document? If your company isn't a medical device company, what kind of company is it?

Please define:
mGy
ACR
PACS
whole cycle



Please clarify:
How can it not recommend anything outside of the intended use of your product and still be 95% outside of the "scope" of your product?Perhaps it would be helpful if you also defined "scope" as you are using it to refer to your product.

Sorry. Yes, "we" and "our" is the medical device company for which I work.
That device is a PACS - picture archiving and communications system - which is an image review software for radiologists.
mGy is milliGray which is a measure of radiation dose from a CT scanner.
ACR is the American College of Radiology
"whole cycle" is the cycle from patient appointment, determination to do a screening scan, reading the scan (where we would fit in with our device), follow-up, recommendations, and reporting and billing the scan.

The document talks about all those pieces in the "whole cycle" and only has little references to things our product can do. It's not recommending anything outside of standard screening protocols as outlined by professional associations, and it's not recommending clinicians do anything specific with our product. Our product sits in a very small portion of the cycle (reading the scan).
 

Watchcat

Trusted Information Resource
#4
What you describes sounds very similar to sales reps distributing published articles relevant to their product. This sometimes pops up in discussions of off-label use, because sometimes the articles describe an off-label use, and sometimes off-label promotion is the intent of the sales rep, however much they might deny it.

As long as the white paper is not distributed with the product (a customer buying both at the same time is not you distributing them both together), I don't think FDA would consider it labeling. I think any reference to your product is likely to get the white paper tagged as advertising or marketing, given that your company is the one that both wrote it and distributes it.

If you have been searching for regulatory guidance on advertising and marketing, then you have probably been using the right terminology. If you haven't found anything on point, it's probably because this sort of thing isn't usually done (I don't think). I also don't think the fact that your company wants to sell it instead of giving it away has any regulatory impact.

So I would review it like any other marketing or advertising material, to assure that it doesn't make any claims outside of those found in your IFU. (I am assuming you have one).

I might also revise statements like "Product X can help track this" to say something more like "image review software like Product X can help track this," just on regulatory instinct, not because I know of any specific guidance or regulation that says so.
 

Watchcat

Trusted Information Resource
#5
Oh, you might also try something like medical/clinical education/training, since that seems like what this document might be striving for? I don't know if FDA (I assume that's the agency you are worried about) has addressed this type of activity. Might well have, since I'm pretty sure some clever sales reps have tried to pitch their products under this guise as well.
 

markl368

Involved In Discussions
#6
I have a slight twist to this question. If a company does not make a medical device or pharmaceutical, but attaches links on the company website to research where products have been clinically evaluated in such use (off-label), is the company making implied claims by posting these links, even if the company makes an express statement that it "makes no claims" as such? I think these would still be applied claims. And if you have an example of a case where this is so, that would be helpful.
 

Mark Meer

Trusted Information Resource
#7
... If a company does not make a medical device or pharmaceutical, but attaches links on the company website to research where products have been clinically evaluated in such use (off-label), is the company making implied claims by posting these links...
I believe this is what the FDA would refer to as a "solicited" off-label (see examples in this draft guidance), which is dicey territory.

Regardless of the stance of the FDA, however, on its face this practice seems a bit sketchy. You're posting links to off-label uses, but then claiming you're not making any claims as to the uses linked? ...seems a bit disingenuous to me, but's that's just my opinion. ;)
 

markl368

Involved In Discussions
#8
I believe this is what the FDA would refer to as a "solicited" off-label (see examples in this draft guidance), which is dicey territory.

Regardless of the stance of the FDA, however, on its face this practice seems a bit sketchy. You're posting links to off-label uses, but then claiming you're not making any claims as to the uses linked? ...seems a bit disingenuous to me, but's that's just my opinion. ;)
Thanks- I totally agree with you but I had not seen the guidance you referenced. This has been VERY helpful!
 
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