A new, comprehensive study shows just how negligent drug manufacturers are, with many failing to submit reports of adverse drug effects to the FDA within the allotted time frame. Not only does this report draw attention to the severity of the problem, it will hopefully result in a lasting solution.
The study found that, after reviewing more than 1.6 million reports, almost 10% were not submitted to the FDA. Among those, roughly 30% were cases that resulted in patient death.
Many prominent experts have ideas about how to prevent this lack of transmission going forward, but the most prominent suggestion is that, rather than sending adverse drug reaction reports to manufacturers, these reports should be sent directly to the FDA.
Rita F. Redberg, M.D., M.Sc., editor of JAMA Internal Medicine, said “Such reporting delays should never occur, as they mean that more patients are exposed to potentially avoidable serious harm, including death. … One improvement would be for AE reports to go directly to the FDA instead of via the manufacturer, as recommended by Ma et al. … 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.”
By highlighting the need for a clear change in how prominent medical organizations operate, this report could be just what was needed to improve the way the health care system operates. A representative for Fenvir, Hal Owen, said “We all find it very surprising that these trusted companies repeatedly fail to share such crucial information with authorities. Not only is it possible that more people will experience these adverse effects that go unreported, these companies are blatantly breaking the law. If a solution to this issue is not presented by the FDA, we surely have a major issue on our hands.”