Through recently deployed initiatives, FDA is taking advantage
of new data systems to gather and assess drug risk data and promote
easier public access to adverse event and recall information. The
two projects, Mini-Sentinel and openFDA, offer greater efficiencies
than existing methods, such as the voluntary reporting process and
Freedom of Information Act requests.
The openFDA initiative focuses on enhancing the Agency's public
disclosure of information on adverse events, medication errors, and
product recalls. In a recent blog post, FDA Chief Health Informatics
Officer Taha Kass-Hout discusses the rollout of an application
programming interface that provides software developers and
researchers access to millions of drug and device recall reports.
Several companies are already integrating this data into their
products and services, and at least one new website allows users to
query adverse event information. The San Francisco Gate outlines other
potential benefits of the interface for startup companies, such as
using its information to improve existing technologies and learning
to avoid mistakes others have encountered during the FDA review
process.
Mini-Sentinel, a $116 million pilot program partnering FDA with
private companies, actively pursues adverse event data by mining medical record databases for signs that
drugs may be linked to problems. Before this initiative, FDA
had to rely on voluntary reports from manufacturers, health care
providers, patients, and caregivers—a method that yields
copious amounts of information but has limited value because of its
random reporting. Mini-Sentinel's standardized approach for
gathering data directly from the 18 health plans and insurance
companies participating in the program enables FDA scientists to
hone in on the root causes of an adverse symptom, and the Agency
has already required new warning labels as a result of these
analyses. Although the pilot contract ends in September 2014, FDA
officials and many industry leaders would like to see some form of
Mini-Sentinel adopted as a permanent program.
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