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 proposing to amend 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, as provided in current agency rules, or by manufacturers that possess these reports. The proposed rule is intended to preempt 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 that is vital to protection of the public health.