We haven’t done anything more than skim it, but we thought our readers would like to know that the FDA released its long-awaited proposal to allow generic drugmakers to use the CBE process to change their labels today – as it common, on a Friday afternoon. Here’s a link to it. This is just a preliminary draft that will open the proposal to a comment period. Here’s the FDA’s description:
We are proposing to change our regulations to expressly provide that ANDA holders may distribute revised labeling that differs from the RLD upon submission of a CBE-0 supplement to FDA. FDA’s proposed revisions to its regulations would create parity between NDA holders and ANDA holders with respect to submission of CBE-0 supplements for safety-related labeling changes based on newly acquired information. This proposal is also intended to ensure that generic drug companies actively participate with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements. If this proposed regulatory change is adopted, it may eliminate the preemption of certain failure-to-warn claims with respect to generic drugs.
FDA, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” at 16-17 (emphasis added). Note that, this reference is limited to warning claims, and does not purport to reduce preemption with respect to design defect claims recognized in Bartlett. Even so, it seems like a huge flip-flop from prior FDA statements in various contexts (some of which are discussed here) that it does not intend to affect civil litigation. It sure intends to affect it now.
The FDA acknowledges “concerns about temporary differences in safety-related labeling for drugs that [it] has determined to be therapeutically equivalent.” Id. at 18. It proposes an Internet webpage to keep track of such differences. Id. at 19-20.
There are technical changes proposed to the CBE process generally, which will affect all such submissions, whether by generic or innovator manufacturers. Id. at 22-25, 32-33.
There’s an interesting addition, proposed §314.70(c)(8)(iii), which claims to codify FDA practice regarding what changes are, and are not, amenable to “this narrow exception to the general requirement for FDA approval of revised labeling prior to distribution.” Proposal at 28-29. This amendment should be examined with an eye to whether it might restore some preemption to innovator products under the Levine/Mensing rationale.
The FDA is also proposing to extend CBE changes to the “highlights” section of drug labeling. Proposal at 30-32.
The section on “Legal Authority” (id. at 35-38) appears at first glance to have a glaring hole in it, as the analysis does not deal at all with the statutory basis for the sameness requirement contained in Hatch Waxman. The only reference to Hatch-Waxman is vague: “Nothing in the Hatch-Waxman Amendments or subsequent amendments to the FD&C Act limits the Agency’s authority to revise the CBE-0 supplement regulations to apply to ANDA holders….” Id. at 39.
This proposed rule is not retroactive. Id. at 44.
Incredibly, even after explicitly stating (as quoted above) that it intends to restrict preemption, the FDA states that this “proposed rule does not contain policies that have federalism implications.” Id. at 45.
Details of how comments concerning this proposal are to be submitted are found on pp. 43-44, 45.