Dear President-Elect Obama, The FDA Is Mismanaged. Sincerely, The FDA
A letter to President-Elect Obama from nine FDA scientists makes alarming charges of mismanagement at the FDA, alleging incompetence, intimidation, and inappropriate industry influence.
According to the letter:
- Scientists and doctors have been threatened and told, on occasion, to ignore FDA regulations.
- Devices have not been properly labeled.
- Managers without appropriate experience have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns.
- FDA experts have been excluded from product meetings because manufacturers felt that they were "biased."
- Manufacturers have been allowed to market their products without FDA approval.
For some reason, we weren't given a copy of this letter, but an apparently similar letter from concerned FDA employees to Congress last fall is available here (PDF).
FDA Scientists Allege Mismanagement at Agency [CNN, via Public Citizen]
(Photo: Scott M)
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Comments:
Nice. I deal with the FDA (in particular the Center for Devices & Radiological Health) every day. I know their address by heart. I would really like to get my hands on a copy of that letter.
This doesn't come as a shock. The FDA needs a good cleaning and restructuring.
I will give them credit on the last point. There was the guy who marketed his "prescription" pistol for the elderly. [gizmodo.com]
this doesnt surprise me at all. after seeing that absurd hfcs syrup on commercial, im fully prepared to accept the fact that if a "fact" comes from a corporation or area of government, it is a lie.
bribery: the great unequalizer.
@bohemian: I had a professor in college who went on sabbatical and spent it working at different places as a consultant. The FDA was one and Pratt and Whitney was another. He said he would trust flying on a plane much more than consuming anything cleared by the FDA due to there being much more money spent on safety and testing in the aerospace industry compared to what the FDA has in its budget and the actual power it has for ensuring the safety of food and drugs.
The shortcomings of the FDA will only truly become clear when the New Orleans levees break, allowing roux and gumbo to spill out all over America.
When you elect a government whose sole purpose is to grease the wheels of capitalism, this is what you get.
There should have been no surprise when the FDA, CPSC, EPA, and so on, complained of political interference and mismanagement.
This isn't to be written off as incompetence. Offices in the executive branch were intentionally deconstructed to render them less effective. The by-product of mistrust was by design. People expect less from offices they don't trust. Moreover, they are willing to be taxed less when they perceive their government as less effective.
Huh? Where is the inappropriate industry influence in Chicago politics?
One this is certain. Trains run on time in Chicago, and the working class is quite strong there.
Given that Obama has so far appointed an RIAA lawyer to head up the justice department, and a Raytheon lobbyist as the dep. Secretary of Defense, I really don't think I think he's going to give a damn about the "inappropriate industry influence". Hell at this rate he'll appoint a pharmaceutical lobbyist to head up the FDA.
@Joshua Willis: He probably would. It is the same man who said he would turn to Former Generals, conservatives, and Republicans to "figure out his Foreign Policy", and Warren Buffett for Economic Policies.
@sarabadara: Amen to that. I worked in the bio-tech industry right around the corner from their headquarters.
"Managers without appropriate experience have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns."
Just about every job I've ever had has similar stories. When Obama gets done cleaning house with government jobs, he needs to work on the private sector.
Our Companies are being run by morons and assholes.
Thanks for your insight, the consumerist has benefited from your expertise on matters of Chicago politics and how they pertain to the FDA.
For more like this, visit www.redstate.com
/sarcasm
Can I have my Vioxx back now?
@IrvCrapper: And it's the greenest city in the US! San Francisco and Portland come to Chicago for tips! Srsly!
I guess when you're Daley and you've been Daley as long as you have been, you can just INFORM people they're putting green roofs on everything in sight and not really have to worry about whether people like it or not.
Point #4 ("experts ... excluded ... because ... they were biased") reminds me of an all-too-easy-to-forget fact: Biased opinions are not necessarily wrong opinions.
@se7a7n7:
"When Obama gets done cleaning house with government jobs, he needs to work on the private sector."
Wow, socialism at its best. Yes, that's exactly what we need - the government to appoint managers for the PRIVATE sector.
Meh, give them some bail-out money and be done with it...
@Joshua Willis: Who better to reform something than someone who knows how to exploit it?
Once you remove the ability to directly profit from something, the person can be invaluable.
@se7a7n7: Welcome to the US government!
Once you're hired it's too much of a pain to fire you, so your managers in order to make themselves look better promote you rather than discipline you. Once you get high enough in the chain people are impressed at how quickly you've risen so they pick you for more important tasks.
Incompetence can be more of a + than a hindrance, especially for managers. The best part is, once you've been in there for 20+ years you get your pension and then you get hired to be a consultant/contractor for twice what you were getting paid in and you still get your pension.
@bohemian: "good cleaning & restructuring"
completely agree. & i think the procedure should be performed blindfolded by 2nd-year dental degree students. without anesthetic. & utilizing some of those improperly labeled devices.
@IrvCrapper: Exactly. What's to be expected of government, when those elected to run it, actually hate government, and foreswear to "drown it in a bathtub"?
We reap what we sow, and the 8-year harvest is coming now to fruition... and it's very very very very poor.
@savvy9999: Absolutely right. History may look back and decide that Bush was the president who made working for the government a for profit industry.
@Triborough: I'm not sure I follow. The letter is talking about the current administration, not Obama. If you recall, Obama has made it clear that he would be reintroducing "science" back into science based agencies such as the EPA, CDC, FDA, etc.
@snowburnt: Actually, I think the circumstances are different. Bush intentionally appointed anti-regulation, anti-science ideologues to senior positions- essentially putting the fox in charge of the hen-house. This was done for two reasons: 1) To give big business whatever they wanted. 2) To intentionally get people to not trust the government, so that when they propose cutting budgets, programs, etc. and letting the industry "regulate itsself" then people would be OK with it.
@bohemian: Yeah, I'm pretty sure any competent consumer has known about this for nearly a decade. The reason I say that is because I have seen things about this on the news, on TV, that box people watch all the time. Remember when the FDA didn't want to irradiate chicken? There was a huge investigation that revealed someone had greasy money. Don't remember why but I definitely remember watching something about that on 60 minutes. This isn't Bush's fault. The FDA has been corrupt for a very long time. No one has had the guts to do anything about it because some big companies have big money in FDA members. Big farming and drug corporations.
@snowburnt: So you are asserting that Obama is turning a black hat hacker into a white hat?
Flipping from good to evil and back again is common. Look at Tony Snow.
@aftercancer: Teddy Roosevelt, where are you when we need you?
(Sure, I know he is dead, but he was sure a pro-consumer president for his time and being a wealthy man.)
@Joshua Willis: What do you expect when the journalism industry fails to report on other viable alternative political party candidates and then says "those candidates will not be covered because they have no chance in winning".
@meechybee: sure thing, just autograph this novel entitled "A New Hope - The Defeat of Arthritis: Heart Attacks and Strokes Strike Back"
oh and by the way, you're most likely going to die sooner and we aren't liable
@Skiffer: full speed ahead on the U.S.S. Dollar - powered by me, you, and the ability to print endless amounts of money
Half ass work and mismanagement from the top????
Seems like the American way to me!
It has long been known that the pharmaceutical industry and FDA have a revolving door policy. It is also known that big pharma funds the FDA pursuant to legislation (PUDFA - Prescription User Drug Fee Act). How can you regulate a business that funds your paychecks?
Higher walls need to be put in place between businesses and the FDA. Very very high walls that not even ninjas can get over! =P
@ARP:
"To intentionally get people to not trust the government, so that when they propose cutting budgets, programs, etc. and letting the industry "regulate itsself" then people would be OK with it"
I agree with this theory. It is very solid and sound and is quite in line with what the powers to be generally do. Interestingly, Noam Chomsky would probably say the same thing.
If you wish to read an interesting case, read Dr. David Graham's full story. He is the FDA scientist who went against the FDA and brought down Vioxx. Quite a good read if one would like some more insight into the specific FDA problems and what he faced and still faces.
-Phex
-3rd Year PharmD/MBA Candidate
We all know the FDA really represents and protects the health of the Food and Drug companies. Why it is taking so long for anyone to do anything about it is the frustrating part. When Bush took office I knew it was going to be at least 8 years before things MIGHT get better. I knew they were going to get worse if anything. I don't know how low his administration has driven this once great public defender agency. Pity.
They're all (gov't agencies) just the personification of the "Peter Principle".
Already knew this due to their agenda to use their religions to regulate women's bodies. They are more concerned about politics than health.
Heck right around 2005 they appointed a VETERINARIAN to head the Women's Health department. Because what, women are cows?!!
The FDA, FCC and the food industry all work together to make sure we are unhealthy and ripe for the doctors to give us prescription drugs and make us more sick. Why is Aspertame, MSG, and high fructose corn syrup still on the market? Because they make us sick and eventually diseased, just what the AMA wants. It's a travesty of huge importance, but most people just don't see it this way!!
Incompetence, intimidation, and inappropriate industry influence - those are some of the basic tools of Chicago politics!