GAO: FDA can’t estimate its own budget needs

WASHINGTON (AP) — 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.

“We have to be able to talk about the funds we need, and how we’re using the money, with more detail than FDA has in the past,” said Dr. Joshua Sharfstein, the agency’s deputy commissioner.

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.

Currently, the federal government pays for just over 30 percent of the FDA’s medical products budget. As a result, the FDA is approving more new products but is spending far less to make sure they are being used safely.

“The approval of new products has increasingly become the beneficiary of the agency’s budget,” according to the GAO report.

Between 2004 and 2008 the agency failed to inspect all U.S. drug manufacturing plants every two years, as required by law. In other areas, such as reviewing reports of negative drug side effects, the FDA could not even say how much money and manpower it spent.

Investigators recommended the FDA conduct a comprehensive assessment of its current workload and use that to develop future budget requests.

Sens. Ted Kennedy, D-Mass., and Charles Grassley, R-Iowa, and Rep. Henry Waxman, D-Calif., requested the GAO probe.

“This report makes it clear that the FDA has to get a handle on its own resource requirements and how to use resources more effectively,” Grassley said in a statement.

Under the Bush administration, FDA officials often insisted the agency had sufficient funding, even when its own advisers said it desperately needed more. In 2007, the agency’s independent group of science advisers said the FDA was in danger of failing in its mission due to a lack of expertise and resources.

“American lives are at risk,” the group concluded.

Sharfstein said President Barack Obama is aware of the agency’s funding woes and is working to boost its budget for safety and inspection activities. The administration’s fiscal year 2010 budget proposal would increase FDA’s federal funding by more than 14 percent, to $2.35 billion from $2.06 billion. The spending bill passed the House earlier this month and is moving through the Senate.

Obama tapped Sharfstein to fill the FDA’s No. 2 position in March. A pediatrician and former Baltimore Health Commissioner, he reports to FDA Commissioner Margaret Hamburg, who was confirmed by the Senate in May.

FDA officials already are working to keep better track of how the agency uses its funding.

“We’ve actually been working on this since we started here, but it’s a big agency and it’s going to take some work to get to the level of detail people want,” Sharfstein said.