Posted by Michael Wonder on 21 Mar 2017
Drug, device industries get one year delay on off label rule
20 March 2017 - The FDA is hitting the pause button on a recent rule affecting what drug and device manufacturers can say about the off-label uses of their products.
The rule (RIN:0910-AH19), published by the FDA in January, is important because it regulates how manufacturers can discuss the unapproved uses of their products with health-care providers. Currently, companies can face criminal prosecution and civil liability if they tout their products to doctors and the public for off-label uses the FDA hasn’t specifically approved..
The FDA is pushing back the rule’s effective date from March 21, 2017, to March 19, 2018. The FDA says the extra time will allow it to respond to an industry petition objecting to how it put out the rule on intended uses of regulated products. Pharmaceutical and device industry groups claim the agency didn’t follow proper rule making procedures, and asked the agency to stay the rule indefinitely.
