New FDA rule on product liability may have no impact
There's been a lot of speculation recently that the FDA would change a rule to preempt state prescription drug product liability laws. However, according to a health care policy note from Citigroup, the new product labeling rule --which does in fact assert that FDA approved labels preempt state laws-- will have no effect.According to Citigroup, the declaration is part of the rule's preamble and so is not legally binding. It's simply a restatement of existing FDA policy.