But apparently that isn’t the only problem, according to a new report (pdf) from the GAO:

FDA could not provide data showing its workload and accomplishments in some areas, such as its review of reports identifying potential safety issues with specific medical products. Without such information, FDA cannot develop complete and reliable estimates of its resource needs.

If I’m reading this right, the problem isn’t just that the FDA doesn’t have enough money — but that it doesn’t even know how much money it doesn’t have.

The agency is getting a huge boost in the president’s 2010 budget proposal — $511 million, or 19 percent. Much of that money will pay for more than 1,200 new hires. That means a 30 percent staffing boost over two years, when you include the 1,500 new employees hired this year.

The numbers prompted some back-and-forth with legislators, as you might expect. A few Republicans thought they were too large; Democrats hinted they might be too small.

But the Goldilocks-esque search for a middle ground can seem very arbitrary. The FDA says, for example, that it needs money to hire 220 new food safety investigators, which will allow it to conduct 4,000 additional inspections every year. But why is 4,000 the right number? Why not 3,000, or 5,000, or 10,000?

Obviously there are political realities at work. The FDA can’t ask for too much extra money, but it has to ask for something extra, because Congress (and the public) is deeply unhappy with its performance over the last few years. Still, the figures often seem arbitrary, and that encourages Congress to poke holes in the budget. If there’s no solid reason for doing 4,000 extra inspections, why pay for them?

So it was encouraging to hear Joshua Sharfstein, the agency’s acting commissioner, talk about developing new metrics for the food and drug safety programs. He said, essentially, that it doesn’t make sense to measure the agency’s progress by the number of inspections it conducts.

A key management goal is to connect the investments that you are making, and the American public is making, to clear public health outcomes… we have to measure our success by how many people are dying or getting sick, not how many people we’re hiring or how many buildings we’re building.

If the FDA could quantify the impact of 220 new food inspectors on public health, it would probably have an easier time getting that request through Congress.

(Incidentally, the public health outcomes Sharfstein mentioned have actually gotten worse in recent years, according to data from the Centers for Disease Control.)

Contrast that with the peanut recall earlier this year, where almost a month elapsed between the initial reports of contamination and a complete recall of the Peanut Corporation of America’s product line.

FDA officials say they’re taking a harder line with food producers, and that’s a positive development.

Still, the pistachio story highlights some of the ongoing gaps in our food safety system. The FDA learned about possible contamination from Kraft Foods, which found salmonella in trail mix made with Setton pistachios. It turns out, though, Kraft found salmonella in trail mix on four other occasions, dating back to December 2007.

But private labs don’t have to report their findings to the FDA — so the agency never learned about those tests.

..a lack of information is one of the most significant factors that limit the FDA’s ability to identify and properly act on safety concerns regarding dietary supplements and foods with added dietary ingredients.

I think there’s an important point to draw from this report. We talk a lot about the FDA’s budget and staffing woes. And the agency is certainly underfunded — you can’t expect the FDA to properly regulate foreign food producers when it has less than a half-dozen foreign offices.

But I think we’re also learning that the FDA does a poor job gathering and analyzing data.

We saw this during the peanut recall last month: The FDA didn’t even know Peanut Corporation of America had a facility in Texas, nor did it know the company’s products had repeatedly tested positive for salmonella.

We saw it during last year’s salmonella outbreak, when the FDA struggled to trace tainted produce back to farms in Mexico. And we’re seeing it again now with GAO’s report on dietary supplements.

The FDA has to regulate two huge global industries. It can’t possibly hope to inspect every food/drug producer on an annual basis — not unless its staff grows exponentially. But if the agency is going to build a risk-based inspection system, it needs to do a much better job with data collection.

Google, for example, can identify a flu outbreak up to two weeks before the Centers for Disease Control identifies it. How? By aggregating search data: When lots of people in the same city or state start searching for “flu” and other related keywords, there’s an outbreak starting.

That’s not to say ensuring food and drug safety is as simple as analyzing search keywords. Obviously it’s not. But the FDA needs to think about its own creative ways to analyze data. Are certain food producers riskier than others — based on what they produce, where they’re located, how they’ve performed in the past? Are clusters of prescription drug users reporting similar symptoms?

The Internet makes it incredibly easy to gather and analyze huge volumes of data — but only if agencies decide what they want to analyze.

First, I think it underscores the need to merge FDA’s food safety functions with those of the Agriculture Department’s Food Safety and Inspection Service — in other words, creating a single food regulator. 

Why? We’ve learned that USDA bought peanuts from PCA and used them for school lunch programs. In fact, it was one of the company’s two biggest customers. And it regularly sent inspectors to review records at PCA’s processing facility. But so did the FDA, the agency in charge of regulating peanut products.

So we had two federal agencies inspecting the same facility — a consequence of our splintered regulatory system.

What’s more upsetting, though, is that neither agency prevented this outbreak. The FDA found problems at the PCA plant in 2001 — among them, that plant workers used insecticides near food-processing equipment — but it was eight years before the agency could do another inspection.

This shouldn’t come as a surprise. The agency lost more than 1,000 employees in the last decade. It receives about 25 percent of the nation’s food safety budget, and regulates 80 percent of its food supply. (The Agriculture Department visited PCA more often, but the agency is also understaffed and underfunded, relative to its workload.)

So if the Obama administration is serious about food safety reform, it needs to provide a bigger budget and better staffing.

In an interview with The Today Show’s Matt Lauer before Sunday’s Super Bowl, Obama said he isn’t happy with FDA’s inspections process.

Well, I think that the FDA has not been able to catch some of these things as quickly as I expect them to catch. And so we’re going to be doing a complete review of FDA operations. I don’t want to prejudge this particular case, but there have been enough instances over the last several years –- and at bare minimum we should be able to count on our government keeping our kids safe when they eat peanut butter.

HR 758, the FDA Globalization Act, was introduced Wednesday by Reps. John Dingell, D-Mich., Bart Stupak, D-Mich., and Frank Pallone, D-N.J.

The bill would require foreign factories that produce drugs and medical devices to be inspected at least every two years, the standard for domestic companies. New fees on imports would help pay for more inspections, and the bill would also give the FDA more room to impose larger fines on companies for faulty imported and domestic products.

In a statement, Dingell said,

“Every few months brings another crisis — E. coli in spinach, contaminated heparin, tainted peppers, and now salmonella in peanut butter that has killed eight people and sickened more than 483 people. The time to act is now.”

The bill has been referred to the House Energy and Commerce Committee.

It’s a promising step for the agency, which is simply terrible at inspecting foreign plants: Less than 30 percent of foreign drug plants, for example, are checked on schedule. So the FDA deserves a lot of credit for starting the program and investing $30 million to open those offices.

But the announcement leaves some unanswered questions. In the United States, FDA inspectors can walk into any food or drug plant, unannounced, and conduct an inspection. Will they have the same access in countries like China and India, which don’t have a strong regulatory culture? It’s doubtful.

Certainly this is an improvement over the current system: The FDA has to fly personnel into each country for inspections, which are often announced weeks in advance. It’s not perfect, though, and it will require strong cooperation from the host countries. (FDA sources say China and India are receptive to the agency’s efforts.)