Data Shows Supplement Companies Failing to Report Adverse Events
Many people have most likely read a news headline that featured a horrific story about an individual who had the wrong body part amputated or had an instrument left inside his body cavity after surgery. These extreme surgical medical errors are known as adverse events, or shocking health-related events that should simply never happen.
However, many people may not be aware that adverse events aren’t limited to surgical procedures. These events can also happen as a result of taking a particular drug or dietary supplement.
Unfortunately, new data shows that some dietary supplement companies are failing to report adverse events that happen to consumers taking the drug. Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, companies are obligated to report these events.
Adverse Event Reporting Requirements for Supplement Companies
The Dietary Supplement and Nonprescription Drug Consumer Protection Act, enacted December 2006, requires manufacturers, packers and distributors of dietary supplements to report to the Food and Drug Administration, or FDA, any serious adverse effects of any supplement they market in the U.S. This includes any events reported by consumers ingesting the product.
Under the law, a product is considered a dietary supplement if its goal is to supplement the human diet. The product also must contain, among different ingredients, vitamins, minerals, herbs, or amino acids.
The adverse event can be serious or mild. A serious adverse event is one that results in death, hospitalization, or disability or incapacity. The Dietary Supplement Act outlines instances that constitute adverse events including an overdose or withdrawal of the drug or supplement.
Any company that becomes aware of an adverse event, serious or otherwise, is required to report the occurrence to the FDA within 15 days of becoming informed of the event. The company is obligated under the law to submit what’s known as an adverse event report, or AER.
Reasons Behind the Underreporting
However, the FDA indicates that many of these companies are failing to report these events. The speculation is based on the number of adverse events that are found by the company compared to those reported to the company by consumers.
Essentially, the results indicate that there are fewer instances reported by the company than there are by the consumer. In one occurrence, good manufacturing practice inspections, known as GMP inspections, revealed that over 1,000 consumer adverse events were reported at a particular company yet none were actually reported by the company.
The failure to accurately report these events hinders the ability to accurately inform future victims. Fortunately, the FDA is in the process of reviewing the procedures involved with submitting the AERs.