On August 18, 2014, the U.S. Food and Drug Administration (FDA) announced on their official blog the release of a drug labeling application programming interface (API) on openFDA, an online database made available to the public in June 2014. The new API offers statistics regarding drug labeling and enforcement, like the number of drug label submissions each year and the breakdown of who reports adverse events.
In the context of the drug labeling API, an adverse event refers to when a person experiences an undesirable response associated with the use of a prescription or over-the-counter drug, such as a serious side effect or poor product quality. Those experiences can be submitted to FDA through an adverse event report. According to the new API, the number of annual adverse drug event reports has increased substantially in ten years. In January 2004, 12,978 adverse drug events were reported to FDA. In January 2013, the number of reports was 81,588. Not surprisingly then, the number of FDA monitored drug product recalls has risen substantially as well. In January 2014 there were 17 drug recalls. In January 2013 there were 383.
Labeling and manufacturing violations of FDA requirements account for 21% of drug product recalls. In the blog, FDA’s Chief Health Informatics Officer Taha A. Kass-Hout referred to approved drug labeling as a “living document” because, even after approval, labels need to be updated as new information about the safety and effectiveness of a drug unfolds.
“In some cases, the approved labeling for a prescription drug can be extensive, consisting of 20,000 words or more,” Kass-Hout said in the blog. “It can be a daunting task to study more than one labeling to better understand a class of drugs, or to compare drugs, and to keep up with their regular changes.”
Classifying a drug and ensuring a label contains all required elements can be difficult. Registrar Corp’s Labeling and Ingredient Review Service helps drug companies determine the likely classification of their products and helps ensure their drug labeling is in compliance with FDA requirements. For more information about FDA drug regulation, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.
See the FDA blog here.