FDA, NIH Launch Food-Safety Reporting Site

WASHINGTONThe U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) launched the Safety Reporting Portal (SRP), which eventually will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. The Web site currently can be used to report safety problems related to foods, including animal feed, and animal drugs, as well as adverse events occurring on human gene transfer trials. Consumers also can use the site to report problems with pet foods and pet treats.

The portal will be a key detection tool in improving the countrys nationwide surveillance system and will strengthen our ability to protect the nations health, said FDA Commissioner Margaret A. Hamburg. We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public.

The new Web portal includes different features for different types of reporting:

Reportable Food Registry: Industry will have a more user-friendly electronic portal for submitting reportable food reports that are required by law. This electronic portal collects reports from the food industry and public health officials regarding problems with articles of food, including animal feed, that present a reasonable probability of causing serious adverse health consequences or death to humans or animals.

Pets: Pet owners and veterinarians will be able to use the portal to report product problems with pet foods and pet treats.

Animal drugs: Animal drug manufacturers can report adverse drug events associated with animal drugs.

Clinical Trials: Biomedical researchers involved in human gene transfer clinical trials can report an adverse event, indicating whether it might be an unanticipated consequence of the product being tested. Trial sponsors can use the portal to prepare a report, print it and send it to the agency to satisfy reporting requirements for investigational new drugs.

In the future, the system will encompass other types of clinical trials and, eventually, safety problems arising from products regulated by a broad array of federal agencies. This is a first step toward a common electronic reporting system that will offer one-stop shopping, allowing an individual to file a single report to multiple agencies that may have an interest in the event.