The Food and Drug Administration is facing mammoth demands for its decisions on which drugs are safe and what should be examined more carefully. A new study published last week by the Archives of Internal Medicine offers an ambitious proposal to determine a drug's risks sooner than might otherwise become evident, reports the New York Times.

The authors of the study propose a system to examine widely prescribed drugs through safety analysis. This would pool data as it emerges from clinical trials of a medication, aggregating the information for a fuller picture of a drug's harms and benefits.

The agency also has added staff members in all divisions to monitor drug safety, strengthened its Office of Surveillance and Epidemiology and instituted a postmarket safety tracking system for new drugs. At the same time, Congress has given the FDA authority to require drugmakers to enforce risk management programs for certain drugs, and to conduct postmarket studies.

Nevertheless, there are plenty of experts who think the FDA needs more power and a bigger budget to investigate new drugs and evaluate studies required to gain approval of the drugs.

"There is this kind of dogma in medicine that you shouldn't use any drug for the first seven years after it is released, because it takes that long to figure out its harms and benefits," said Dr. Michael Steinman, an assistant professor of medicine at the medical school of the University of California, San Francisco.

For more on the FDA and technology:
- see this New York Times article

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