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

Pharmacy Times, Volume 0,0

Drug safety will remain one of the FDA's highest prioritiesnext year. The agency's 2007 budget proposal calls for an additional$4.7 million in federal funds and user fees "to continue tostrengthen our capacity to recognize and act on emerging drugsafety 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 fillapproximately 3.7 billion prescriptions per year, and?the effectof these medicines on the full spectrum of our population causesunforeseen problems to surface that may not have appearedduring the sometimes-lengthy drug-review process."

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