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Sharfstein’s departure–the management connection

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The Wall Street Journal reports today that Dr. Joshua Sharfstein, principal deputy commissioner at the Food and Drug Administration, is leaving to become the top public health official for the State of Maryland.

As the Journal notes, Sharfstein’s departure has possible ramifications for the FDA’s oversight of drugs and medical devices. But there’s also a connection to the Obama administration’s performance management agenda.

As Federal Times wrote back in September, Sharfstein has been the driving force behind creation of FDA-TRACK, a web site that monitors the agency’s performance in dozens of areas and was cited as a model for other agencies by no less than federal Chief Performance Officer Jeffrey Zients.

These kinds of sites require constant attention to stay relevant:  it will be interesting to see whether Sharfstein’s successor (not yet announced) shows the same commitment to keeping this model going.

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Smithsonian warehouse roof collapses

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The roof of the Smithsonian Museum Support Center in Suitland, Md., collapsed this morning, WUSA9 is reporting.

The building is the Smithsonian’s main off-site storage warehouse for museum artifacts. It’s unknown what, if any, artifacts may have been damaged by the roof collapse, according to the report. Firefighters responded to the scene before 7 a.m. and shut off electricity and natural gas to the warehouse.

Officials have been warning about the dangers of roofs collapsing from the weight of all the snow the area has received. According to Michael McGill, spokesman for the General Services Administration’s National Capital Region, damage to buildings maintained by GSA has been minimal so far.  A sprinkler burst in one of the buildings at the Food and Drug Administration’s headquarters campus in White Oak, Md. GSA also had to shore up the roof of its 1 million square foot warehouse in Franconia, Va., which was weakened by damage from December’s storm.

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What you don't know…

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I’ve done a fair amount of reporting on the FDA’s budgetary troubles over the last 18 months. The agency is chronically underfunded, with a rapidly-growing workload and a budget that has fallen 12 percent since 2002.

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.

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Making the case

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Deadline day around here and things are a bit busy, but I wanted to comment on an FDA appropriations hearing I covered this morning.

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?

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One step forward, one step back

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I’m a little surprised at the FDA’s quick reaction to the news of possible salmonella contamination in pistachios. The agency convinced Setton Pistachio, the nation’s second-largest pistachio producer, to recall its entire 2008 crop — even though nobody has reported a confirmed case of salmonella poisoning from those nuts.

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.

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Food, drugs and data

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The Government Accountability Office has a new report out on the Food and Drug Administration: Apparently the agency doesn’t have enough information about the ingredients in dietary supplements to decide if they’re safe.

..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.

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Too many regulators, not enough money

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The recent peanut butter recall — products from the Peanut Corporation of America (PCA) were contaminated with salmonella — makes a strong case for completely overhauling our food safety system.

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.
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Obama wants FDA review after peanut recall

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President Barack Obama wants a review of the Food and Drug Administration after a massive peanut butter recall for salmonella contamination.

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.

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Bill proposes more FDA inspections overseas

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As the Food and Drug Administration issues a massive recall of peanut products, a new bill could give the FDA stronger investigative powers.

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.

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Foreign challenges at the FDA

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The FDA announced this week that it will start opening foreign offices – first in China and India, and eventually in Latin America, Europe and the Middle East.

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.)

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