4 ms·

Jesus man. You seem awfully certain. Here is a ruling from December that affirms 1st amendment rights to market off label uses: http://www.reedsmith.com/file

Jesus man. You seem awfully certain. Here is a ruling from December that affirms 1st amendment rights to market off label uses: http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Caronia.pdf http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Car... " Caronia argues that he was convicted for his speech -- for promoting an FDA-approved drug for off-label use -- in violation of his right of free speech under the First Amendment. We agree. Accordingly, -3- we vacate the judgment of conviction and remand the case to the district court. " It is uncertain whether marketing off label is protected by the 1st amendment. The courts don't all agree.

lvs 13y ago
> The courts don't all agree. The one case you cite is very fresh precedent in a single Circuit, and it's highly controversial. No other Federal Circuit has applied First Amendment standards to FDA misbranding regulations before. Even within the Second Circuit (three states), is it still illegal under law to misbrand a drug in marketing materials. The decision in Cariona hinges on the question of whether "misbranding" and "promotion of off-label use" are different narrowly defined legal scenarios. The Second Circuit was concerned that, in the latter scenario, doctors may be legally deterred from promoting off-label use, which is a common practice in medicine and research. You should not take away from this case that drug marketing is now a First Amendment free-for-all. Yes, I am awfully certain.
spartango 13y ago
This is an interesting case, however its important to point out that the legal debate around this is ongoing. This ruling only applies to the 2nd Circuit at this point. It's looking like a Supreme Court case will be necessary to ultimately decided this issue, given the murkiness around it. Until then, however, off-label drug marketing is not something companies get away with without a substantial legal battle (often not worth it), and the FDA has so far collected billions of dollars in settlements and fines through successful off-label drug marketing suits.
djjose 13y ago
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.

lvs 13y ago

> The courts don't all agree. The one case you cite is very fresh precedent in a single Circuit, and it's highly controversial. No other Federal Circuit has applied First Amendment standards to FDA misbranding regulations before. Even within the Second Circuit (three states), is it still illegal under law to misbrand a drug in marketing materials. The decision in Cariona hinges on the question of whether "misbranding" and "promotion of off-label use" are different narrowly defined legal scenarios. The Second Circuit was concerned that, in the latter scenario, doctors may be legally deterred from promoting off-label use, which is a common practice in medicine and research. You should not take away from this case that drug marketing is now a First Amendment free-for-all. Yes, I am awfully certain.

spartango 13y ago

This is an interesting case, however its important to point out that the legal debate around this is ongoing. This ruling only applies to the 2nd Circuit at this point. It's looking like a Supreme Court case will be necessary to ultimately decided this issue, given the murkiness around it. Until then, however, off-label drug marketing is not something companies get away with without a substantial legal battle (often not worth it), and the FDA has so far collected billions of dollars in settlements and fines through successful off-label drug marketing suits.

djjose 13y ago

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.