The report, issued February 10, 2016, describes information required to be provided to the agency by drug manufacturers as “poor” because it contains holes in key categories.
The U.S. Food and Drug Administration Adverse Event Reporting System, or FAERS, exists to protect consumers by providing them with an online listing of harmful reactions, injuries and pain and suffering caused by approved products. But the system’s effectiveness only is as good as its accuracy.
Out of 528,192 FAERS submissions in 2014, a total of 503,154, or 95 percent, came from drug manufacturers. The rest of the submissions came voluntarily from doctors and patients. That’s the good news. The bad news is that, out of the 95 percent, less than half included the key categories of patient age and gender, event date and medical term explaining the problem.
“The FDA needs to update reporting requirements and compliance policies to help industry capture better adverse event information from new forms of manufacturer interactions with health professionals and consumers,” states the Pharmacoepidemiology & Drug Safety report, titled “Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014.”
Without the key categories, the FDA is hindered in its ability to create correct warnings. Without correct warnings, the public is at risk.
“With increasing pressure for the FDA to approve drugs fast but with less clinical testing, it is a major concern that postmarket surveillance has major problems that are not being addressed,” Thomas Moore, of the Institute for Safe Medicine Practices, told the health and medicine Web site STAT.
Moore said FAERS, a well-intentioned “critical tool,” has not evolved with the ever-changing marketing techniques of the pharmaceutical industry. The system last was upgraded in 2001.
“It is time for the FDA, the medical community, and industry to start work on a badly needed modernization…,” he said.
Consumers can learn about FAERS by visiting its FAQ Web site or calling 855-543-3784.