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.
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
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."
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