In a Federal Register Notice (link here) the FDA formally announced today that it’s revisiting its pending proposal to kill generic preemption. The comment period has been reopened and will extend until April 27, 2015. In addition, there will be a webcast “public meeting” on the proposal on March 27, 2015. Details as to both are in the notice.
We’re frankly not surprised. As we explained back in 2013, when the FDA’s original proposal debuted: (1) allowing unapproved changes to generic labeling violates the governing statute’s requirement that generic and branded labeling be the “same”; (2) the Agency’s conscious attempt to defeat preemption in civil litigation is a huge flip-flop from the FDA’s prior position that it did not act with the intent to affect civil litigation; and (3) the Agency’s cost-benefit analysis was laughably incomplete. At last December’s ACI Drug/Device conference, an FDA representative publicly stated that any final rule might not “look like” what the Agency had currently proposed. We wondered at the time if such changes might require reopening of public comments.
One of the reasons given by the FDA’s notice for the additional proceedings is to “promote transparency.” We certainly think that’s a good idea, given the evidence that’s come out (via congressional testimony) that the FDA secretly met with representatives of the plaintiffs’ bar – but nobody else – in the run-up to its original proposal.
We still don’t think that this proposal is going anywhere. No matter what the FDA does, the statute still mandates sameness. The FDA certainly can streamline the process of updating generic labels, but it cannot authorize, without congressional action, any procedure that would allow generic labeling changes without agency pre-approval, because the resultant labels wouldn’t be the same. That’s the biggest sticking point, because as long as agency pre-approval is required, preemption exists.