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:

• identities may be disclosed if both the voluntary reporter and the person identified in an adverse event report or that person's legal representative consent in writing to disclosure, but neither the FDA nor any manufacturer in possession of such reports shall be required to seek consent for disclosure from the voluntary reporter or the person identified in the adverse event report or that person's legal representative
• identities of the voluntary reporter and the person who experienced the reported adverse event may be disclosed pursuant to a court order in the course of medical malpractice litigation involving both parties
• the report, excluding the identities of any other individuals, shall be disclosed to the person who is the subject of the report upon request

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