New Report Highlights Alarming Flaws in FDA’s Drug Reporting System

A new report from the Institute of Safe Medication Practices (ISMP) has noted some concerning gaps in the FDA’s current drug reporting system. The dangerous drug lawyers at Edelman, Krasin & Jaye are concerned that those gaps could leave patients vulnerable to drug side effects without receiving proper warning about the risks.

The new report from ISMP studied 12 months of reporting to the FDA’s Adverse Event Reporting System (FAERS) between 2013 and 2014. The total number of reports examined during that time was 847,039. Some of those reports were submitted directly to FAERS, while the large majority (96.6%) came through drug manufacturers. Upon further scrutiny, a significant discrepancy in reporting accuracy was noted between the two.

Inconsistencies in reporting

Reports from drug manufacturers were much less likely to be complete than those submitted directly to FAERS. More than one-third of reports from manufacturers failed to include the patient’s age, and even more neglected to note the date of the adverse event. Less than half of the manufacturer reports included sufficient information to be considered “complete” by ISMP. On the other hand, 85 percent of reports submitted directly to the FDA were complete.

Inconsistencies in reporting also left some portions of the population more vulnerable to drug side effects than others. For example, adverse events were much less likely to be reported when they involved newborns and children than adults. Possible birth defects linked to certain drugs were also less likely to be reported. Reports also came in more frequently for newer brand name drugs, rather than their older, generic counterparts. This is particularly unfortunate considering 86 percent of prescriptions written are now filled by generic medications.

About the FAERS

The FAERS is a database of information about all types of drugs and medical devices. The system is crucial in the tracking of potential dangerous drugs that allows the FDA to take further action involving those drugs in the future. Since its inception, the system has been improved to allow for reporting on a global level by standardizing basic terminology and definitions involved with adverse event reporting.

Despite its benefits, FAERS is far from ideal, as the ISMP has revealed. Gaps in reporting mean inconsistent information that may keep the agency from acting on newly discovered side effects in a timely fashion. Without that critical information, patients may unknowingly be exposed to risks and side effects that could have devastating consequences.

Getting help from a drug side effects attorney

At Edelman, Krasin & Jaye, our product liability lawyers work with clients that have been injured by medications they believed to be safe. In some cases, those injuries can be life-changing or even deadly. Lack of sufficient warning about possible side effects from the drug manufacturer often makes the circumstances that much more tragic. In those situations, victims are often entitled to compensation for their injuries and non-economic losses.

If you are injured by a drug prescribed by your physician, help is available. Contact the legal team at Edelman, Krasin & Jaye at 1-800-469-7429 today to get a free review of your case and learn your legal options.