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
Implied preemption in prescription drug cases basically comes down to how a judge feels about whether a manufacturer can unilaterally change its label to “strengthen” warnings under 21 C.F.R. §314.70(c) – the so-called “Changes Being Effected” (CBE) regulation. Our side claims that the CBE regulation doesn’t change anything fundamentally, because the FDA still has to
When you argue implied preemption as much as we do in prescription drug product liability litigation cases, you get to know the plaintiffs’ come back arguments in your sleep. Chief among them is that because the FDA’s so-called “changes being effected” (“CBE”) regulation, 21 C.F.R. §314.70(c), allows drug manufacturers to strengthen safety language without prior