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Registry to Include Animal Drugs, Pet Food

By Dan Flynn and Suzanna Schreck

Since early September, federal law has required any facility that manufactures, packs, or holds human or animal food to issue an electronic report to the U.S. Food and Drug Administration (FDA) if the company realizes it shipped potentially harmful food into commerce. Yesterday the FDA and National Institutes of Health (NIH) launched a new Website that will eventually accept reporting--from consumers, academia, and industry--on pre- and post-market safety data on a wider variety of products, including animal feed, animal drugs, and pet food.

The new site, called the Safety Reporting Portal, provides "greater and easier access to online reporting," according to a joint agency statement released yesterday.

"The portal will be a key detection tool in improving the country's nationwide surveillance system and will strengthen our ability to protect the nation's health," said FDA Commissioner Margaret 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."

According to the release yesterday, the new Web portal includes a number of different features:

-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," according to the FDA. "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."

The agencies did not release a timeline for when the site will be fully functioning, but did note that, in the meantime, the new portal will redirect individuals seeking to submit reports to the right contact at the appropriate federal agency, including the U.S. Department of Agriculture, the Environmental Protection Agency, or the Consumer Product Safety Commission.

Full post as published by Food Safety News on May 25, 2010 (boomark / email).