Critics see accountability risk if FDA rule changes take hold

Under revised language proposed by FDA, companies no longer have to “provide adequate labeling” for non-FDA-approved uses of their products that they know about. Patient advocates worry that companies will use the new rule to avoid liability for injuries caused by their products’ off-label applications. The controversy is the latest flash point in a growing and increasingly contentious national debate about free-speech rights of companies and off-label uses of their products.