Protecting the Identities of Reporters of Adverse Events and Patients; Preemption of Disclosure Rules

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The Food and Drug Administration (FDA) is amending its public information regulations to help ensure that the identities of those who report adverse events associated with human drugs, biologics, and medical devices, and the identities of patients are held in confidence and not disclosed by FDA or by manufacturers that possess these reports. This final rule preempts the establishment or continuation in effect of any State or local law, rule, regulation, or other requirement that requires or permits disclosure of such identities. This action is being taken to maintain the agency's ability to collect information about safety risks of FDA-regulated products and is vital to the protection of the public health.