[djjose]

I've been out of the industry for a while but I spent 5 years working on regulatory projects in the MD&D sector.

We never advertised off-label. Whether it's legal or not, I do recall you'd get slapped by the FDA for lack of controls. We had many cases where doctors would use a product off-label and it'd come back to us in the form of a complaint or defect (product comes back as defective, we investigate and find out the doctor was using the product for an off-label procedure it wasn't designed for and would fail, hence the 'defect'). At which point we'd have to proactively train doctors to not do this and other corrective action measures would have to be put in place. If upon investigating we find this would be a good use of the product, we'd have to go through another round of FDA fun (sometimes clinicals and how much testing depended on some factors, definitely rounds of internal testing and implement new QA tests and procedures to ensure the product can work for the new use and have proper fault tolerances as well as new labeling and training, etc).

Now, do companies try to skirt around this? Sure. Part of my job at the time was to make sure we didn't. FDA Warning letters are no joke in this industry, it can literally put you out of business.