FDA PLANS NEW WEB-BASED SYSTEM TO MONITOR PRESCRIPTION DRUG SAFETY

APRIL 01, 2006

Drug safety will remain one of the FDA's highest priorities next year. The agency's 2007 budget proposal calls for an additional $4.7 million in federal funds and user fees "to continue to strengthen our capacity to recognize and act on emerging drug safety concerns."

In outlining the agency's budget plan at congressional hearings, Acting FDA Commissioner Andrew C. von Eschenbach, MD, told a House subcommittee that "US pharmacies fill approximately 3.7 billion prescriptions per year, and?the effect of these medicines on the full spectrum of our population causes unforeseen problems to surface that may not have appeared during the sometimes-lengthy drug-review process."

The extra money in next year's budget will allow federal drug regulators to launch a Web-based system to provide FDA analysts faster access to adverse event reports. Known as AERS II, this system "will allow the FDA to more easily evaluate potential safety issues, and improve our ability to take follow-up actions to protect patients," Dr. von Eschenbach said.




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