Business

FDA can't estimate its needs

The Food and Drug Administration -- which has struggled to fulfill its mission of regulating food, drugs and other consumer goods that make up nearly a quarter of the U.S. economy -- does not have the expertise to forecast its own budget needs, according to congressional investigators.

While many lawmakers and consumer advocates have long complained that the agency lacks the staff and equipment to accomplish its mission, the Government Accountability Office says the agency doesn't even have "the data to develop a complete and reliable estimate of the resources it needs."

The GAO places some of the blame on the FDA's lopsided budget -- which dedicates significant resources to approving new products but far less to tracking their safety once they've reached the market.

FDA officials acknowledged the problems uncovered by the GAO, saying they are working to get a better picture of the agency's spending and how much additional funding it needs.

The GAO report, released Monday, is the latest in a series to document the problems facing the agency. The FDA has spent the last few years careening from one public health crisis to the next. They have included the recall of the painkiller Vioxx -- which was linked to heart attacks -- contaminated blood thinners imported from China and an investigation into a salmonella outbreak that dragged on for weeks before peppers were identified as the culprit.

The agency's product review program is largely funded by user fees from drug and medical device companies, while the company's safety inspections are funded by taxpayer dollars. Over the last 10 years, funding from private companies increased nearly 270 percent, while funds from the U.S. government grew less than 70 percent.

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