On May 24, 2010, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) launched the Safety Reporting Portal (SRP) web site allowing increased accessibility to submit reports concerning FDA regulated products. SRP allows even the concerned citizen to submit a safety report related to foods, drugs, and veterinary products. “As access to this internet tool increases,” says Benjamin L. England, Food and Drug Law professional and founder of FDAImports.com, LLC, “the number of safety reports to FDA will certainly increase as well.” Because some safety reporting is mandatory for certain products by some private manufacturers and processors, ‘required organizations,’ use of the SRP will become the upgraded replacement for all safety reporting to FDA. For instance, the SRP now replaces FDA’s previous Reportable Food Register. One upgrade to the electronic and online reporting system permits consumers to submit reports concerning adverse events and products. Product Manufacturers, Processors, Packers, Warehouses, Researchers, and Health Care Professionals already had the ability (and sometimes the duty) to report safety problems to FDA.
Currently, in order to report an adverse event to FDA, even federal investigators, as well as required organizations, must submit duplicate reports to several federal agencies. Each of these reports requires use of different forms, vocabularies, reporting timeframes and criteria. The SRP standardizes all submitting requirements across commodities, industries and market participants. Previously, multiple agencies were receiving the same safety report in varying formats. This had the potential to cause confusion among government authorities concerning which department should investigate and potentially take enforcement action. “SRP shows that FDA and NIH are serious about taking action toward uniting and coordinating the diverse Federal requirements that are currently in place for the reporting and reviewing of adverse events,” says Benjamin England.
Similar to the old portal system SRP requires certain organizations to submit Mandatory reports relating to Reportable Foods, Animal Drug Safety, and Gene Transfer Research. SRP now enables anyone who has internet access, including consumers, the ability to report a safety concern voluntarily. SRP was created with advanced software that makes reporting a problem or concern simpler than ever before. “This is a very simple system to access,” says Benjamin England, “Simplicity leads to more reports, including those from consumers, which is likely also to lead to a higher number of lower quality reports that FDA must sift through.”
FDAImports.com, LLC is a consulting firm founded by Benjamin L. England who has 17 years of experience working inside the FDA. If you have concerns regarding the safety of your product contact FDAImports.com, LLC to speak with a Food and Drug Law specialist before an adverse events report is submitted targeting your product. FDAImports.com works side-by-side with Federal Regulations and can show you ‘the way through’ the US market while complying with safety guidelines.
