Promptness is not a virtue at the FDA

With all the concern about contamination of imported food ingredients, especially from a major exporter like China, you'd think the US Food and Drug Administration would be eager to make whatever information it has available to US food producers as quickly as possible. You know what's coming next:

Lee Sanders, a senior vice president with the American Bakers Association, requested FDA documents on imported honey in 2002. The Washington-based association wanted to know about a pesticide in honey imported from China, she said in an interview.

"You would hope that those types of requests would be handled in a more expeditious way," she said. (Bloomberg)

The US has a law -- a good law -- that is relatively uncommon in the world. It is called the Freedom of Information Act, and it allows someone to get information from government agencies, even information that is not public, like reports, records, memos, emails and other internal documents. If you want the information all you need to do is file a Freedom of Information request. US law then requires the agency to release the information "promptly" or tell you why it won't or can't be released. Apparently the Food and Drug Administration uses a different time scale then the rest of us. Requests filed as long as four years ago have yet to be honored. If that's what "promptly" means I'd hate to see what "take your time" would amount to. It's not just a couple of cases, either:

The FDA's 20,365 unfilled requests for information exceed the totals for the departments of Defense and Justice. One company, FOI Services Inc., accounts for 44 percent of the backlog, according to the agency. Researchers, consumer groups and individuals say the delays limit their ability to alert the public to food and drug dangers and to hold the FDA accountable.

[snip]

The FDA's oversight of food and drug safety has come under criticism by advocacy groups and lawmakers. They say the agency failed to act effectively before Vioxx, a Merck & Co. painkiller, was withdrawn in 2004 because of a link to heart attacks and strokes and didn't alert the public more recently to heart risks associated with GlaxoSmithKline Plc's diabetes drug Avandia. They also fault the FDA for failing to prevent contamination of peanut butter, spinach and pet food. (Bloomberg)

Why the huge backlog? Frivolous requests by crazed citizens wearing tinfoil hats? Individuals do make requests -- why shouldn't they? -- but most of the are from drug companies, consumer groups and one particular company: FOI Services, Inc., which accounts for almost half of the backlog. Who are they?

FOI Services, of Gaithersburg, Maryland, says on its Web site that it has collected more than 150,000 FDA documents, amassing what it bills as the ``World's Largest Private Library of FDA-Related Documents & Reports.''

The company seeks material for customers, mostly drug and medical-device companies that don't want their identities revealed because they may be seeking information about a competitor's product, said Marlene Bobka, vice president of FOI.

FOI Services, founded by lawyers whose clients sought information from the FDA, also requests documents to post on its Web site on speculation that the information will attract buyers.

"What we're doing really is aggregating requests from industry," Bobka said. Without her company, the FDA "would still get these requests. They would just come from different firms," she said.

It's impossible to assess independently whether FOI Services has made the FDA's backlog worse than it would be otherwise, and Sadler said he isn't sure.

The company won't reveal its profit on documents. A two- page report on an FDA inspection from 2002 sells for $50.95 on the FOI Services Web site. The FDA billed the company $5.40 to process and provide the document, according to Sadler.

Don't get upset that the FDA has had to put on extra employees to keep from being inundated by this data trawler out to make a buck.

As the FDA's backlog has increased, the agency has cut back the number of workers handling requests. The equivalent of 88 full-time staffers worked on filings last year, down from 123 in fiscal year 1995, according to [Fred Sadler, head of the FDA office that handles the public inquiries].

Meanwhile, parties ranging from private citizens to the consumer watchdog Public Citizen are waiting around with Pfizer and Merck for responses to requests they made years ago.

And your local baker, wondering if the honey he is using is laced with pesticide.

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I have been a "victim" of this particular little item too, but under Clintons Administration. It was finally honored this past year when I requested information on what nuclear weapons information specifically had been de-classified and sold to the Chinese as "space technology" from the Dept of Commerce. Most of this related to the equipment used in a re-entry. Now folks Revere is right about the stuff above and you might have doughnuts laced with pesticides. On the other hand, how many things sold as satellite technology need a re-entry vehicle? Hell, they try to keep them up there rather than bringing them down. You only need a re-entry vehicle and processes to ensure it lands somewhere. So its a Clinton Bash I am throwing up on this one. I wont veil this one at all.

But for us all there is a push to modify the FOIA in short order that will require "prompt" responses to those calls. You might have to pay for the copying costs, but indeed everyone should get stuff more timely. Had we known that this stuff was likely being sold for campaign contributions a good part of the left would have been all over them as the right would have. It would also have slowed the process for Iraq a bit under requisite declassification of the documents that none of us got to see. Might not have gone in there without a lot better evidence.

So we meet in the middle on this one. Neither side likes what we are looking at.

By M. Randolph Kruger (not verified) on 22 Jun 2007 #permalink

The backlogs have been getting worse. Some of it is rapacious companies like FOI. But much of it is government agencies that don't want the rest of us to know what's going on. That's why we had to have a law (FOIA). That law already requires promptness but it isn't honored. I am for opening the doors and windows. I don't care whether the Republicans or Democrats do it and I am deeply disappointed, so far, with the Dems failure to open up the earmarking process. They are better than the Republicans but no where near as good as we need them to be and if they don't get themselves in gear the netroots will be all over them and for good reason.

The honey was laced with chloramphenicol, an antibiotic banned in North America in the late 1980's...as far as I know they have never stopped using it and in Canada...Canada #1 honey is a grade and does not indicate Country of Origin...oh the web we weave.

This is spot on. I sat in on a closed doors government medical meeting recently. When someone brought up that some potentially injurious data (to private industry) could be attained under the FOIA, the response from the parties involved was: "we'll make sure it takes long enough to process so that it won't really matter."

Kind of defeats the whole purpose doesn't it?

By DollarsandDisease (not verified) on 22 Jun 2007 #permalink


So its a Clinton Bash I am throwing up on this one. I wont veil this one at all.

Far be it from me to defend Bill Clinton about anything at all, but the story has a bunch of villains. Yes, the Chinese PLA really did take the US to the cleaners over sensitive rocket and missile technology during the 1990s. I have seen estimates that China saved as much as $100B in developmental and experimental costs by acquiring key technologies directly. And this does in fact have enormously damaging implications for US national security now and in the future.

However, a huge measure of blame for this has to be placed on the shoulders of executives at Lockheed, Loral, Motorola and Hughes. All of these firms eventually pled guilty to having violated the US Arms Export Control Act and the International Traffic in Arms Regulations in their dealings with China. And if you look at the technologies provided, and the circumstances under which they were given out, it would have been crystal-clear to the officers of the corporations in question that important laws were being broken.

What these companies opted to do was to do the deals, cash the checks, and hope no one found out, with the assumption that even if anyone did find out, a lackadasiacal American public and a bought-off American political class would allow them to skate away with minimal consequence.

They did in fact get found out, and they were in fact allowed to escape with token fines and no jail time. I would myself have chosen to hold a short ceremony on the steps of the Capitol and to hang those executives by their necks until dead. A personal preference.

Anecdotally, I went out drinking once with a guy who had worked for more than a decade during the Cold War as a high-level defense sector lobbyist in DC. After having had a few, he related his suspicions that certain critical technologies had been leaked to the Soviets by American companies. Not enough to let the USSR catch up, but to keep them close enough on American heels as to justify to the Congress that further massive expenditures on big-ticket weapons systems be funded.

He offered no proof of this and I can likewise offer none, other than to accurately relay his comments. I wish I could say that the motives of American big business are sufficiently pure in my estimation as to preclude such ugly scenarios of betrayal for profit. I cannot in truth say so. Witness how casually Corporate America resorted to treasonous malfeasance in the cases which we do know about.

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