FDA, NIH Launch Web-based Safety Reporting Portal
The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) last week launched the Safety Reporting Portal (SRP) Web site to better enable consumers and industry members to submit reports concerning FDA regulated products.
“As access to this internet tool increases, the number of safety reports to FDA will certainly increase as well,” said Benjamin L. England, food and drug law professional and founder of FDAImports.com, LLC,
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 example, 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.
Previously, in order to report an adverse event to FDA, required organizations – and even federal investigators – had to submit duplicate reports to several federal agencies. Each of these reports required use of different forms, vocabularies, reporting timeframes, and criteria. This had the potential to cause confusion among government authorities concerning which department should investigate and potentially take enforcement action. The SRP standardizes all submitting requirements across commodities, industries, and market participants.
“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,” added England.
As with 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.
“This is a very simple system to access,” said 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.”
“As access to this internet tool increases, the number of safety reports to FDA will certainly increase as well,” said Benjamin L. England, food and drug law professional and founder of FDAImports.com, LLC,
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 example, 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.
Previously, in order to report an adverse event to FDA, required organizations – and even federal investigators – had to submit duplicate reports to several federal agencies. Each of these reports required use of different forms, vocabularies, reporting timeframes, and criteria. This had the potential to cause confusion among government authorities concerning which department should investigate and potentially take enforcement action. The SRP standardizes all submitting requirements across commodities, industries, and market participants.
“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,” added England.
As with 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.
“This is a very simple system to access,” said 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.”