FDA Cannot Regulate Off-Label Use by Physicians: Decisive Court Decision  
(Thursday, July 15, 2021)
Medical practice is regulated by the State medical boards not by FDA and FDA does not get to tell doctors what they can or can not prescribe to their patients, even if it is off label. A recent court ruling, although about a narrow case, confirms this principle once again. The case in hand was about FDA banning a specific use of a medical device approved for other uses decades ago. The DC Court of Appeals ruled that “FDA did not have legal authority to ban an otherwise legal device for a particular use.” FDA approves products for specific uses as described in their FDA-approved label (on-label uses). Once the product is available commercially and physicians have access to it, they are allowed to use a given product for practically anything they feel is appropriate their patients. The sacred relationship between a physician and patient is protected by law and only subject to supervision by state medical boards. And FDA has always stayed clear of this issue. However, in the case in question, FDA banned the device for a specific use while allowing the device to be used for other purposes. This was a very specific case involving one device used only at one location in the country, but the implications of this ruling could have wider impact. And the court saw that. The challenge in this case is that although FDA cannot ban off-label uses by physicians, it has the right to ban manufacturers from off-label promotion. In this case, the clinic offering the off-label treatment is also the owner of the 510k. So, technically, FDA could have done that, but the court saw the precedence this could set up and overturned FDA’s ban. The ability of a clinic to offer treatment options to their patients should not be controlled by the FDA, even in special cases like these. FDA cannot ban specific uses of a product by physicians, and that’s that.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: mkumar@fdamap.com
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