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Editor's Note
September 2015

Improving Manufacturer Reporting of Adverse Events to the US Food and Drug Administration

Author Affiliations

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA Intern Med. 2015;175(9):1566-1567. doi:10.1001/jamainternmed.2015.3574

Our awareness of the potential adverse effects (AEs) of newly approved drugs and devices is limited. Premarket trials are often small and of limited duration, and the patients in clinical trials are healthier than unselected patients in routine clinical practice. Thus, the public and physicians rely on the US Food and Drug Administration (FDA) Adverse Event Reporting System to inform us of unknown or unsuspected risks associated with use of drugs and devices.

In this issue of JAMA Internal Medicine, Ma and colleagues1 reviewed almost 1.27 million AE reports submitted in a 10-year period and found that approximately 10% of these reports, including more than 40 000 reports of patient deaths, were not received by the FDA within the required 15-day time frame for reporting serious AEs. Such reporting delays should never occur, as they mean that more patients are exposed to potentially avoidable serious harm, including death. However, no disciplinary actions have been taken when companies fail to submit reports to the FDA in the time frame required. Clearly, the lack of consequences contributes to a lack of deterrence for these illegal and dangerous delays.

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