U.S. Food and Drug Administration Reasoning in Approval Decisions When Efficacy Evidence Is Borderline, 2013-2018

CONCLUSION: The FDA has no mechanism to find or tradition to cite similar cases when weighing evidence for approvals, resulting in standalone, bespoke decisions. These decisions show highly variable criteria for "substantial evidence" when flexible evidential criteria are used, highlighted by the recent approval of aducanumab. A precedential tradition and suitable information system are required for the FDA to improve institutional memory and build upon past decisions. These would increase the FDA's decisional transparency, consistency, and predictability, which are critical to preserving the FDA's most valuable asset, the public's trust.PRIMARY FUNDING SOURCE: U.S. Food and Drug Administration.PMID:34543584 | DOI:10.7326/M21-2918

Source: Annals of Internal Medicine - September 20, 2021 Category: Internal Medicine Authors: Perrine Janiaud Telba Irony Estelle Russek-Cohen Steven N Goodman Source Type: research