July 1995 Bulletin

New FDA rule protects IDs in MedWatch report

A new rule amending the U.S. Food and Drug Administration's public information regulation is scheduled to go into effect July 3 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 the FDA or by manufacturers that possess the reports.

The final rule preempts the establishment or continuation in effect of any state or local law, rule, or regulation that requires or permits disclosure of such identities.

The exceptions to the prohibition against disclosure are that:

The FDA announced it would strengthen the protection of confidentiality of voluntary reports when it launched the MedWatch program in June 1993.

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