The FDA posted on its website today a regulatory initiative that will affect many prescription drug/implied preemption arguments. It’s an agency’s proposal to change amend its “Changes Being Effected” regulations for drugs, devices and biologics rule to restrict the ability of manufacturers to make label changes that add/strengthen warnings prior to FDA approval.
We’re both swamped today, so we’ll have more to say about this later, but the upshot of the proposal is to limit CBE labeling changes to only “new” or “materially” different information that the Agency has not already considered. A second proposed change to the CBE regulation will make explicit what that CBE changes to add stronger drug warnings are subject to the warning standard in old 201.57(e) (that is, reasonable evidence of an association). Other types of CBE changes would have to meet the corresponding regulatory standards for scientific validity that already apply to those types of label changes in the non-CBE context.
Since plaintiffs argue that CBE lets manufacturers make any changes they want, the regulatory amendment will restrict this argument (the most potent plaintiffs have) to new or significantly increased risks supported by adequate scientific evidence – eliminating it from cases where the FDA’s already reviewed essentially the same evidence
We posted on this same point last April. Somebody in the FDA must be reading our minds – or at least our blog.