According to a recent research letter in the Journal of the American Medical Association (JAMA), an analysis of serious adverse event (SAE) reports from January 1, 2004 and June 30, 2014 (with certain exclusions) concluded that drug companies were more likely to delay the reporting of such instances within the required 15 calendar days, if death was the patient outcome. Close to 10% of SAEs were not reported on time.
While the reasons for the reporting delays aren’t clear, it’s plausible that they’re caused by the more comprehensive verification process that’s required for SAEs like patient death. The ramifications of the inaccurate reporting of SAEs and/or drug-event connections could be devastating to patients, as well as companies. For example, safe medications could prematurely be withdrawn from the market.
The analysis also suggests that reporting SAEs directly to the FDA, rather than to drug companies, could help companies better meet the regulatory reporting requirements.
To read the letter in JAMA, click here.
