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Reporting of serious AEs to FDA often delayed by drug companies

Nearly 10% of adverse events are not reported to the FDA within the 15-day period drug companies have to disclose the events, according to recently published data.

“Our analysis provided evidence that drug manufacturers delay reporting of serious [adverse events] to the FDA. Strikingly, [adverse events] with patient death were more likely to be delayed,” Paul Ma, PhD, Carlson School of Management, University of Minnesota, and colleagues wrote.

Ma and colleagues analyzed data from the FDA’s Adverse Event Reporting System from Jan. 2004 through June, 2014, to assess the trends in manufacturers’ delays in submitting expedited reports of adverse events (AEs) to the FDA.

In total, 1,613,079 AEs were included in the study.

Results demonstrated that 9.94% of reports — 119,919 without patient death and 40,464 with patient death — were not received by the FDA in 15 days from the receipt of information. Over 5% of reports were received between 16 to 90 days, 2.19% were received between 91 and 180 days, and 2.47% were received more than 180 days after receipt of AE information.

Of AEs that were reported within the mandated 15-day period, 88.25% included events involving patient death compared with 90.71% not involving patient death.

A correlation between patient death and delayed reporting was found in a multivariable analysis.

The researchers noted delays in reporting may be reduced if AEs are submitted directly to the FDA, rather than to drug manufacturers, as is currently done.

“Our findings are likely an underestimate of overall under-reporting or misreporting, given the anecdotal evidence of FDA warning letters to manufacturers alleging downward misclassification of serious AEs. … Further research is needed to better understand the mechanisms behind the manufacturers’ delayed reporting and the optimal regulatory policy toward mandatory disclosures of AEs,” Ma and colleagues concluded.

Rita F. Redberg

In an editor’s note, Rita F. Redberg, MS, MSc, editor of JAMA Internal Medicine, suggested that the FDA should consider revoking a drug’s approval or suspending sales for companies that do not comply with the regulations regarding reporting of adverse events.

“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,” Redberg wrote.  – by Casey Hower

Disclosure: The researchers report no relevant financial disclosures.