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Exploring The New CBE Rule

By James M. Beck and Mark Herrmann

We've now had a chance to review the new "change being effected" (or "CBE") rule finalized by the FDA last week. (Here's a link.) For drugs, the rule is 21 C.F.R. Sec. 314.70(c)(6).

This is what we found.

First, the FDA made one change from the draft rule that it proposed in January to the final rule that it adopted last week. The draft rule said that "newly acquired information" included data "derived from new clinical studies, reports of adverse events of a different type or greater severity or frequency than previously included in submissions to FDA, or new analyses of previously submitted data."

The final rule changes the location of the italicized words. In the final rule, "newly acquired information" includes data "derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to the FDA."

This change clarifies that the (what the heck is that? an adjectival phrase?) applies to all of the types of data, rather than just the adverse event reports.

We found some stuff we like in the FDA's responses to the comments submitted about the draft rule. At page 6, you'll see the FDA's statement that, "A sponsor's submission or FDA's acceptance of a CBE supplement does not necessarily mean that a drug product actually has caused any particular adverse event or type of adverse event." That should go without saying, but we're glad to see it said nonetheless.

One commenter suggested that the FDA should distinguish situations in which a drug company "must" warn of a risk from situations in which a sponsor "may" warn. The FDA rejected that suggestion because the FDA-approved warning on a drug is both a floor and a ceiling on the risk information that should be provided: "FDA has previously stated and reiterates here that it 'interprets the Act to establish both a 'floor' and a 'ceiling', such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise misleading.'" Id. at 7.

As the FDA (and the Supreme Court) has said before, "FDA does not believe that the absence of an express preemption provision with respect to drugs affects the application of the doctrine of implied preemption." Id. at 8.

The FDA devotes a couple of paragraphs to explaining the "rule of construction" found in the recently enacted Food and Drug Administration Amendments Act of 2007. Among other things, "the rule of construction operates to preserve Federal labeling obligations only in the face of an argument that 'this paragraph' . . . 'affects' [the drug manufacturer's] responsibilities." Since the rule of construction is limited to that one paragraph, it cannot be read to apply to the FDAAA (or the FDCA) as a whole.

The FDA rejected one comment's proposal that the agency "provide a comprehensive, written response to every CBE supplement submitted to the agency by a sponsor, describing FDA's ground for approval, disapproval, or, as the case may be, request for modification to the submitted CBE supplement." Id. at 18. The FDA's position may disappoint those who favor Catherine Sharkey's "agency deference" model of preemption, but it does save the agency a lot of work.

Finally, the FDA repeats that the new CBE rule simply codifies what had been the agency's longstanding CBE practice (id. at 22) and repeats the FDA's now oft-stated views on preemption. Id. at 23. And, in a sentence that may occasionally prove useful in litigation, the FDA writes that "at least when a sponsor did not meet the standard to change its labeling through a CBE supplement under this rule to include the warning a plaintiff alleges should have been added to labeling, State law liability that is premised on a failure to warn is preempted." Id. at 24.

We liked this rule when it was proposed back in January, and we still like it today.

Full post as published by Drug and Device Law on August 25, 2008 (boomark / email).