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Editor's Note
September 2015

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

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.

There is another enforcement tool that the FDA could begin to deploy immediately: suspending drug sales or withdrawing drug approval. Federal regulations give the FDA the power to withdraw drug approval “if an applicant fails to establish and maintain records and make [timely] reports [as] required under this section....”2(p3) One improvement would be for AE reports to go directly to the FDA instead of via the manufacturer, as recommended by Ma et al. This would address the delay problem, although additional efforts to make the data available and take appropriate actions are still necessary. Physicians and their patients must be knowledgeable of benefits, harms, and alternatives for a wide choice of treatments, especially those recently approved for which clinical experience is limited.

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Article Information

Conflict of Interest Disclosures: None reported.

Correction: This article was corrected for a typographical error in the second paragraph on July 27, 2015.

Ma  P, Marinovic  I, Karaca-Mandic  P.  Drug manufacturers’ delayed disclosure of serious and unexpected adverse events to the US Food and Drug Administration [published online July 27, 2015]. JAMA Intern Med. doi:10.1001/jamainternmed.2015.3565.
US Food and Drug Administration. CFR—Code of Federal Regulations, Title 21, Volume 5 (21CFR314.80). http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.80. Updated September 1, 2014. Accessed June 5, 2015.