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# Court Clarifies CBE Provision, Attorneys Say
- URL: https://www.fdaweb.com/court-clarifies-cbe-provision-attorneys-say/
- Published: 2021-04-06T12:00:00.000Z
- Updated: 2026-09-14T16:53:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149054

Writing in a Washington Legal Foundation *Legal Opinion Letter*, three Sidley Austin attorneys say a recent 4th Circuit Court of Appeals decision in a case involving Boehringer Ingelheim’s blood thinner Pradaxa clarified the need to ensure that a conclusion about a drug’s risks has been reached by a company to defeat a federal preemption defense under the FDA Changes Being Effected regulation. The attorneys’ [post](https://www.wlf.org/2021/03/26/publishing/fourth-circuit-clarifies-newly-acquired-information-for-changes-being-effected-drug-labeling-purposes/?ref=fdaweb.com) says the case involved state law claims that Boehringer provided inadequate warnings about Pradaxa’s risks.

The plaintiffs contended that the company’s post-FDA approval research revealed “newly acquired information” about the drug’s risks for patients with impaired kidney function and the need for those patients to monitor Pradaxa concentration in their blood. FDA had approved Pradaxa without any such required monitoring.

While the district court agreed with the plaintiffs that information in a company study constituted “newly acquired information” Boehringer could have used to review the Pradaxa labeling through the CBE process, the appeals court reversed that ruling.

The attorneys say the 4th Circuit clarified that scientists’ “hypotheses, differing viewpoints, and even preliminary conclusions” expressed during research, testing, and analysis of a drug’s risks are not “without more” the sort of newly acquired information needed to overcome preemption.

“The 4th Circuit’s decision strengthens drug makers’ preemption arguments going forward and diminishes the legal risks attendant in a vigorous and robust drug development program,” the attorneys write. “*Knight* is consistent with other circuits’ more limited analyses of the ‘newly acquired information’ question…. The 4th Circuit’s more nuanced analysis may prove persuasive in cautioning against a quick trigger in determining the existence of newly acquired information.”