NEW FDA WEBSITE OPENS RECALL DATABASE TO CONSUMERS

A new website that will make U.S. Food and Drug Administration (FDA) data more readily available online may make it easier for consumers to find out about potentially dangerous drugs and faulty medical devices being sold in the American marketplace.

The openFDA website provides APIs (application programming interfaces) that make it easier to obtain raw data and datasets cached by the FDA.

This data supports the approval notices, adverse event reports, recall notices and other public information about drugs and medical devices that the FDA is better known for issuing. Application programming interfaces allow various pieces of software to communicate with one another using standardized data formats.

New Site Should Make Recall Data More Accessible

Taha Kass-Hout of the FDA told the Regulatory Affairs Professionals Society that prior to the debut of openFDA, which is in beta, those in need of this information had to download large amounts of files encoded in various formats or not fully documented, use a browser to point-and-click through databases on the FDA website or file Freedom-of-Information Act (FOIA) requests for documents.

One API available on openFDA has opened the FDA’s Recall Enterprise System (RES) to the public. This is the system that tracks all of the agency’s recall data.

The FDA explains that the new API provides one-call access to all of the agency’s drug, device and food enforcement reports (recalls) dating to 2004.

"The hope is that this API will be useful to developers and researchers interested in FDA enforcement actions,” the agency says. "Developers can now [use] the API to add recalls data to mobile apps or consumer websites. And researchers could use the API to study individual manufacturers, product categories or specific foods or drugs.”

In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices, ranging from bandages and prosthetics to heart valves and robotics.

Data sets available through APIs on openFDA include:

Adverse events – The FDA’s publically available drug adverse event and medication error reports and medical device adverse event reports

Recalls – Enforcement report data, containing information gathered from public notices about certain recalls of FDA-regulated products

Documentation – Structured product labeling data for FDA-regulated human drug products.

Eventually, the agency states, openFDA will provide "a platform for public challenges issued by the FDA and a place for the community to interact with each other and FDA domain experts with the goal of spurring innovation around FDA data.”

Some Are Already Making Use of FDA Information

The Regulatory Affairs Professionals Society says at least one company, Social Health Insights, has launched a website "specifically tailored to making use and sense of the FDA’s data.”

The ResearchAE site provides search tools preset to target recalls and adverse event reports. As of this writing, the site says that search tools for product labels and clinical trials will be coming soon.

Having this information available will assist consumers who have been injured by faulty drugs or medical devices.

Those who have been injured because of a defect the manufacturer knew about, should have known about or should have adequately warned consumers about should consult with an attorney to learn more information about their legal options.