The FDA blows off the GAO

Typically, when the Government Accounting Office says that a government agency should do something, it does so with the best interests of the American people in mind. The Food and Drug Administration (FDA) typically blows them off and does whatever it wants. Which is usually nothing.

The Food and Drug Administration (FDA) is responsible for ensuring the safety of roughly 80 percent of the U.S. food supply, including $417 billion worth of domestic food and $49 billion in imported food annually. Changing demographics and consumption patterns along with an increase in imports have presented challenges to FDA. At the same time, recent outbreaks, such as E. coli from spinach and Salmonella from tomatoes, have undermined consumer confidence in the safety of the food supply.

In November 2007, FDA released its Food Protection Plan, which articulates a framework for improving food safety oversight.

In January 2008, GAO expressed concerns about FDA's capacity to implement the Food Protection Plan and noted that more specific information about the strategies and resources needed to implement the plan would facilitate congressional oversight. This testimony focuses on

(1) FDA's progress in implementing the Food Protection Plan,
(2) FDA's proposal to focus inspections based on risk, and
(3) FDA's implementation of previously issued GAO recommendations intended to improve food safety oversight.

To address these issues, GAO reviewed FDA documents, such as FDA's operations plan, and FDA data related to the plan. GAO also interviewed FDA officials regarding the progress made. GAO also analyzed FDA data on domestic and foreign food firm inspections. GAO also analyzed the status of past recommendations.

So that all sounds well and good, doesn't it? Hundreds of people have been sickened this past week--and the US tomato industry is collapsing.
What is the FDA doing to comply? To protect American citizens?

Since FDA's Food Protection Plan was first released in November 2007, FDA has added few details on the resources and strategies required to implement the plan. FDA plans to spend about $90 million over fiscal years 2008 and 2009 to implement several key actions, such as identifying food vulnerabilities and risk. From the information GAO has obtained on the Food Protection Plan, however, it is unclear what FDA's overall resource need is for implementing the plan, which could be significant.

For example, based on FDA estimates, if FDA were to inspect each of the approximately 65,500 domestic food firms regulated by FDA once, the total cost would be approximately $524 million. In addition, timelines for implementing the various strategies in the plan are also unclear, although a senior level FDA official estimated that the overall plan will take 5 years to complete.

Importantly, GAO has noted that public reporting is the means through which the federal government communicates the results of its work to the Congress and the American people. FDA officials told GAO that they had prepared a draft report on progress made in implementing the Food Protection Plan, but as of June 4, 2008, FDA told GAO that the Department of Health and Human Services had not cleared the report for release. The Food Protection Plan identifies the need to focus safety inspections based on risk, which is particularly important as the numbers of food firms have increased while inspections have decreased.

For example, between 2001 and 2007, the number of domestic firms under FDA's jurisdiction increased from about 51,000 to more than 65,500, while the number of firms inspected declined slightly, from 14,721 to 14,566. Thus, conducting safety inspections based on risk has the potential to be an efficient and effective approach for FDA to target scarce resources based on relative vulnerability and risk. FDA has implemented few of GAO's past recommendations to leverage its resources and improve food safety oversight.

Since 2004, GAO has made a total of 34 food safety related recommendations to FDA, and as of May 2008, FDA has implemented 7 of these recommendations.

Yep--the FDA is in compliance with about 21% of what the GAO recommends. That's a great track record. But--when all is said and done--it's a great metaphor for where we stand today. The American people are in danger because this administration cannot protect them from bad food supply issues that have already been identified and have already been submitted to them as recommendations. We're not talking about unknown threats, variables no one can anticipate or obscure issues that only affect a handful of people. We are talking about major problems facing millions of consumers that have been identified by the GAO.

And, sadly, that's the Bush administration--21% in the approval ratings, and 21% in the compliance ratings.

Congress Blasts the FDA for being Incompetent

This is what oversight is supposed to look like:

(AP) House members chastised the Food and Drug Administration on Tuesday for not doing more inspections of foreign drug manufacturers in the wake of a litany of problems with the blood thinner heparin and other products.

"Last year, this nation's regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people," said Rep. Bart Stupak, D-Mich. "If we don't make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us."

FDA Commissioner Andrew von Eschenbach told a House subcommittee that he has asked the administration for more money to conduct inspections, but he did not specify how much. He agreed that more inspections are needed, but not to the lengths Democrats suggested, which is to inspect every foreign firm every two to three years.

"I don't believe that's the solution to the problem," von Eschenbach said. "It's much more complex, and the solution needs to be much more comprehensive than simply inspecting a facility."

Typical spin from a Bush loyalist--regularly checking out firms is costly, time-consuming and makes everyone pull nervously at their collar, but it's virtually the only way to ensure compliance with the law. What do you get when you "trust" the industry or industries to "self-regulate?" You get cost-cutting, corner-cutting, and dead people.

Spare me that "government is the problem" and that "libertarian" bullshit on this one--the only thing that is going to ensure that we even approach having a safe supply of materials is to have a hard-assed inspector with a clipboard and an eye for detail looking into what these firms are up to.

Republican members of the subcommittee were in agreement with Democrats that the lack of foreign inspections is a big problem.

"We have already heard the numbers that show the imbalance in risk priorities, with most domestic firms inspected about every two years, but literally hundreds of foreign firms that have not seen an inspection, if at all, in a decade," said Rep. John Shimkus, R-Ill. "Clearly these priorities need to be brought closer into balance."

The Government Accountability Office testified Tuesday that the FDA was making progress in conducting more inspections of foreign drug manufacturers, but still inspects relatively few facilities.

The agency conducted 30 such inspections in the last fiscal year and plans to conduct at least 50 this year, according to government auditors.

That's not nearly enough for members of Congress, who point out that there are more than 3,200 foreign drug firms listed by the FDA.

Of course the Republicans agreed--they're not THAT batshit crazy. See, it's not about ideology. It's not about letting the market decide or the individual do for themselves. It's about a safe supply of fucking drugs that actually work. So, out of 3,200 firms, we're inspecting 80 over a two year period? How the hell is that supposed to keep the American people safe? How hard is it to actually do the job? You'd think there wasn't a Bush appointee alive who was even remotely capable of showing up for work.