12:00 AM
Apr 21, 2008
 |  BioCentury  |  Regulation

Standing sentinel

FDA is putting the finishing touches on a strategy for integrating safety data from the entire life cycle of medical products, from controlled trials to real-world clinical settings. The core of the strategy is an active surveillance system, dubbed the Sentinel System, integrating electronic healthcare data that is intended to produce safety signals more rapidly and reliably than the passive systems that have been in place for decades.

Problems with the current adverse event reporting system have drawn headlines during the recent drug safety controversies, but they have been obvious for a long time.

Adverse events are underreported. There is often insufficient clinical data associated with reports to make judgments about causality. And there is no way to determine the incidence of an event because the system doesn't produce data on the number of individuals exposed to a drug or the percentage of adverse events reported.

In 2007, Congress considered a number of approaches to fixing the drug safety system as part of legislation reauthorizing PDUFA. Mark McClellan, former CMS administrator and FDA commissioner, persuaded members from both sides of the aisle to set aside some proposals for increasing premarket data requirements, which would not have helped identify rare safety events but would have substantially increased the time and cost of drug development.

Instead, the FDA Amendments Act of 2007 (FDAAA) mandated the creation of a system designed to collect more and better data about the performance of drugs once they are on the market (see BioCentury, April 23, 2007).

FDAAA instructed the HHS Secretary to collaborate with public, academic and private entities to "develop validated methods for the establishment of a postmarket risk identification and analysis...

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