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Anyone have insights into marketing a 510k device with off label uses? There are strict rules of course, but still avenues for sharing information. Thoughts?
9 min reading time
As originally asked by Brad Brenner.
We have developed and launched web-based CME programs and understand how critical it is to ensure that CME activities are scientifically rigorous, evidenced-based and free from commercial bias. Adhering strictly to ACCME guidelines protects both the manufacturers and accredited providers – and ensures that physicians who do choose to be early adopters and use devices or drugs off-label have access to the latest research and information regarding safety and efficacy about both on-label and potential off-label uses, as well as a review of other therapies currently available for treatment, and the advantages and disadvantages of all options.
CME provides such an important resource for physicians. We developed a course that discussed soft tissue augmentation with an injectable that was already being used off-label by thousands of plastic surgeons and dermatologists. But due to off-label status of those applications, physicians had few resources to access information about safety, efficacy and appropriate technique of the procedures. I literally had physicians calling in to our office who would say “I have my first patient for this procedure coming to my office in 2 hours. Can you get me registered right away so I can take the course before she arrives?” This happened to me more than once so I know this must be at least somewhat common…
Bottom line – manufacturers must absolutely avoid any and all activities related to marketing and promotion of off-label applications, and must avoid any and all activities that could be construed as such. But physicians involved in the development and use of the off-label application can lead educational discussions/presentations about off-label uses, and ACCME-accredited CME activities can discuss off-label uses as well. If you would like additional information about this, send me a LinkedIn message:)
In the absence of particular knowledge of the device, let me outline a generic possibility:
Lets call the features of the device that are in the label as “510ked features” and the features you want to promote that are not in the current label/literature as “new features” for the purpose of this discussion.
The fact you want to promote the “new features” implies that you have some evidence or basis for believing that they work.
P.S. As the original device was 510ked I assume at most you may only need another 510K to introduce the new features- but this could be a wrong assumption. In any case the previous exercise will only help strengthen any regulatory path you might have to take.
Jean Bigoney, RAC, CQE
Sarah H. Stec
Disclaimer: That wasn’t legal advice.
I do think it gets a little tricky when a company’s product has expanded indications in other countries. But, once again, I think you need to be very disciplined and extremely explicit in communications to the market (including giving very clear guidance to your sales team).
Yuri Sokolov, MSc, PhD, MBA
Kiu Leung, Ph.D. – Executive Forums, Western Wisconsin
Jean Bigoney, RAC, CQE
Here is the FDA Guidance on that subject:
If a request for off-label use is made to your company, you are permitted to respond in certain limited ways. But as part of your marketing? You might get away with it for a while. Most likely one of your competitors would blow the whistle on you and then you would be on the receiving and of one of these
Is it worth it when you compare that to the cost of getting the device cleared for what you want to market it for?
John D. Miller
I don’t believe there is any law preventing a subsidiary or distributor from posting this information on the Internet as long as appropriate warnings are used. But I am not a regulatory or legal expert and perhaps others can comment on this.
1. Update risk management documentation to account for off-label risks
In the first case, clear pro-active communication should be done to highlight the risks and prevent future liability. In the second case, be sure that physicians or potential customers will find their way without having your company to be involved at all.
Some years ago, I was working in the field of electrophysiology where a new procedure was not officially approved: AF ablation (atrial fibrillation ablation). The trick was that, as frequently the case, the procedure was already performed routinely in Europe. And that it could be used using catheters and other equipment available on the US market. A typical example of off label.
All companies were very careful in their communication after FDA sent warning letters to some of them. Numerous literatures were also available but we couldn’t even mention it. As for customers quotes, as soon as a company mentions it, it endorses it. At least that’s the position of our legal department.
However physicians aren’t stupid. They simply had to visit the international version of web sites or to attend overseas congresses. Which they did extensively. Once the procedure was finally approved, it was already performed in many sites.
I would always recommend to remain on the safe side because the benefits/risks ratio is too high and anyway not necessarily needed.
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