FDA, MIT Announce Drug Safety System

In the wake of the Vioxx scandal, the FDA is stepping up efforts to employ IT to monitor the safety of drugs after they are marketed to the public.

At a recent conference held by Massachusetts Institute of Technologys Center for Biomedical Innovation, the university and the Food and Drug Administration announced that they have an agreement to collaborate on the development of a real-time drug safety monitoring system.

Currently, the FDA relies entirely on reporting through its MedWatch program, which receives more than 250,000 adverse event reports from patients and health care providers about FDA-approved medications.

Since this approach is voluntary, however, it often results in the underreporting of incidents.

But the MIT-FDA initiative will go further, according to Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, in Washington.

"In addition to voluntary reports the FDA receives from patients and the health care community, the MIT model uses large health care data sets to recognize patterns that indicate unexpected efficacy or problems with safety," Gottlieb said.

This technique is similar to that employed by public health departments and the Centers for Disease Control and Prevention in the search for incidents of infectious disease or bioterrorism.

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Earlier in 2006, the Government Accountability Office issued a report that was highly critical of the FDAs ability to collect and analyze data about drugs after they have been marketed. The GAO report (PDF) specifically recommended that "the FDA systematically track postmarket drug safety issues."

Gottlieb argued that major research advances have made postmarket drug safety monitoring more of a necessity. "More novelty also brings with it more uncertainty, especially when it comes to evaluating the safety of new drugs. When it comes to very novel molecules whose mechanism is unfamiliar to us … It is sometimes going to be harder to predict a priori what kinds of rare side effects may eventually emerge," he said.

Technology, although long neglected in health care, is becoming an increasingly central part of the FDAs work to improve postmarket safety. Earlier this year, the FDA standardized electronic drug labeling, and is now linking that information as it is updated to a free publicly available database, DailyMed.

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