The US Food and Drug Administration is overhauling how it identifies and evaluates safety issues related to drugs and biologics,
as required by provisions in the FDA Amendments Act (FDAAA). The legislation instructs FDA to establish a system that can
access drug safety data on 25 million patients by 2010 and 100 million by 2012. Instead of relying on passive, unreliable
adverse event reports sent to the FDA by doctors and pharmacists, the agency will establish an active postmarket safety surveillance
and analysis system that is able to detect safety signals much more quickly.
This expanded pharmaceutical assessment program, dubbed the Sentinel System, also aims to generate more adverse event reporting
by health professionals, to analyze health information more effectively, and to enhance FDA methods for communicating new
safety information to providers and patients. "We may be entering a new era for determining how drugs should be used on the
market," said Mark McClellan, former FDA commissioner and Medicare chief, now at the Brookings Institution, where he chaired
a June forum on postmarket evidence.
More active postmarket surveillance further promises to have a broad impact on biomedical research and drug development, as
improved understanding of how drugs affect patients in realworld settings informs drug discovery. This creates an opportunity
to use the delivery of healthcare as a discovery platform, commented FDA Commissioner Andrew von Eschenbach at the Brookings
forum. Johnson & Johnson Corporate Vice President Garry Neil predicted that this development can "revolutionize the entire
healthcare system" by supporting new medical products that are more effective and safer and less costly.
McClellan further explained at the June annual meeting of the Drug Information Association (DIA) that an active postmarket
surveillance system reflects a move away from distinct pre- and postmarket regulatory processes and towards a lifecycle approach
to drug development and regulation. Rising FDA concerns about drug safety are "not just a pendulum swing," he commented, but
reflect higher public expectations about drug safety.
One important component of the Sentinel System is a more modern and expanded FDA spontaneous adverse event reporting system
(AERS). Although passive voluntary reporting fails to capture many events or to explain the cause of a medical problem, it
is useful for detecting rare but serious safety signals. To boost voluntary reporting, the FDA is collaborating with the Centers
for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) on standards and a common format for
reporting adverse events for all FDA-regulated products. The FDA also plans to combine safety-signal detection and analysis
for drugs, biologics, medical devices, and other regulated products into an agency-wide FDA adverse event reporting system
(FAERS). And a user-friendly MedWatch Plus portal will allow anyone—healthcare providers, patients, clinical researchers—to
electronically report adverse events on all regulated medical products.
"Spontaneous reporting won't vanish," said Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER),
at the Brookings forum. But it will be conducted more efficiently and linked to broader analytical resources.