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TechnoratiLives are at risk because the U.S. Food and Drug Administration is woefully behind in the latest scientific advances and is under funded, a panel of advisers to the agency said at a public meeting on Monday.
Inadequate staffing, poor retention, out-of-date technology and a lack of resources mar the FDA's ability, the report by a subcommittee of the agency's Science Board said.
(A copy of the 60-page report, FDA Science and Mission at Risk, can be found here.)
"FDA's inability to keep up with scientific advances means that American lives are at risk," the report said.
The panel, chaired by Gail Cassell, vice president for scientific affairs at Eli Lilly & Co., and representatives from Genentech Inc and Wyeth, among others presented their findings to FDA Commissioner Andrew Von Eschenbach and other agency officials.
Eschenbach asked the Science Board to examine the problems that have plagued the agency in recent years including recalls of drugs, contaminated food and toxic toothpaste. The agency regulates products from drugs to food and cosmetics representing about $1 trillion, or a quarter of every dollar spent in the United States, according to the report.
The U.S. Congress passed more than 100 laws expanding the FDA's authority since 1988, but has not increased the funding appropriately, the report found.
Among its recommendations, the panel suggested hiring more scientific talent, naming a chief scientific officer and reorganizing how the agency handles science issues.
The FDA is requesting $2.1 billion in its fiscal year 2008 budget, a 5.3 percent increase over the current budget.
"Without a significant increase in resources," the "recommendations will be superfluous," the report warned.
The panel's report said the agency's track record in regulating the safety of the food supply - noting a systems failure during a recent E. coli food contamination inquiry - " has drawn attention and resources away from FDA's ability to develop the science base and infrastructure needed to efficiently support innovation in the food industry."
Public health is at risk as "reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still hand written," the report said.
Poor retention of critical staff was faulted. The report noted the turnover rate of the science staff is twice that of other government agencies.
The agency lacks a good system of talking to scientists outside the agency, "thus limiting infusion of new knowledge and missing opportunities to leverage resources," it said.
The panel "was extremely disturbed" at the state of the agency's information technology infrastructure, calling it the "weakest but most critical link."
(Reporting by Kim Dixon; Editing by Leslie Gevirtz)
© 2007 Reuters
16 Comments so far
Show AllI do not feel any pity for them. They will just have to hire more educated people to perform the work. Maybe do some outsourcing.
These people can go to college free and get reimbursed by the government. What do they do with their time?
I understand this is not about helping the citizens of the usa.
dlp67 December 5th, 2007 9:59 am
"Wow, a group of corporate types were this critical of the big Pharma-loving FDA; can you imagine how bad the situation must really be?"
The follow-up article will be one which alerts us that these "corporate types",otherwise known as Milton Friedmanites are more than willing to step in to rescue us from a "crisis" which Congress created in the first place by not allocating the necessary funds needed by the FDA to protect the citizens of this country. The behavioral pattern becomes clear once you've read "The Shock Doctrine" by Namoi Klein!
I'm surprised that communities in the US haven't started keeping their own docs, and to hell with the insurance companies.
As for Andrew Jackson, that story is almost certainly false, just like all those other anecdotes that it sounds identical to.
"The panel, chaired by Gail Cassell, vice president for scientific affairs at Eli Lilly & Co., and representatives from Genentech Inc and Wyeth, among others presented their findings to FDA Commissioner Andrew Von Eschenbach and other agency officials."
Interesting, isn't it, that there's no mention of a public health expert on the so-called "Science Board", only Big Pharm.
I don't know if throwing money at this problem is the answer. But the current system favors the suppliers and gives no protection to consumers. FDA, and USDA for that matter, use the information given to them by the makers of drugs, pesticides, cloned animals, genetically modified foods and plants that grow pharmaceuticals. The government doesn't do its own testing.
If Monsanto, or Lilly or Archer Daniels Midland says its product is safe, it goes on the market. Simple as that.
Who's watching the watchdog?
Welcome to Dubyuh's "Faith Based" FDA. It is no surprise that poisonings and epidemics are exploding since no one with scientific credentials has been hired in the last 7 years. Who has been hired? Dozens of graduates of the until recently obscure Regent University. It is Pat Robertson's baby and didn't exist until 1978. Just pray and have faith that you don't come down with anthrax or unchecked E.coli.
Make sure to stay away from hospitals- even emergency rooms, since with Dubyuh's health care plan, there will be no coverage for little people like you. It's the Yo-Yo plan, as in You're On Your Own!
The Republicans, beginning especially with Reagan, think of science as political fast food; they want to have it their way, cooked up to order in a hurry.
NSPIRE: Jackson also kept slaves. Your point?
By the way, there is a difference between semi-literacy (Jackson) and willful ignorance (Bush).
Both were and are presidents.
Jackson was technically Christian, but disapproved of the blind fanatacism of his co-religionists. Bush is an Armageddonist Christian who 'talks to God'.
Jackson fought in the wars his country often started with the original inhabitants of the land the US occupies (gee, sound familiar?). Bush did everything he could to get out of military service.
Jackson took pride in being a child of the Enlightenment. Bush smiles approvingly as creationist museums open, and 'Intelligent Design' skulks into the classroom.
"The FDA is requesting $2.1 billion in its fiscal year 2008 budget, a 5.3 percent increase over the current budget."
And George Bush is requesting another $50 billion supplemental for the disaster in Iraq.
Will the FDA get its miniscule request to help protect the health of U.S. citizens?
GALEN -- Ever hear of the story of ALL CORRECT?
Andrew Jackson's presidency was challenged by his less than complete education, but he was sure a great military thinker, in fact most people don't realize how often they indirectly quote this great man.
His advisor's were constantly amazed by how well he could grasp the complexity of DC politics, which was likely from all of his time as an Indian fighter, and commanding his troops.
After several weeks of noticing a new habit of his, while reviewing documents where he placed a couple of letters next to many paragraphs and at the end. The staff were perplexed, and while not wanting to insult the most powerful man around, their curiosity got the better of their caution. "Mr. Prez why don't you use your initials (AJ) when reviewing and approving someone's document?"
Have you yet guessed the answer? Andrew leaned back and explained that he was letting everyone know that what he had read was
"O l K orrect"
So O.K. ~ All Correct
Does this remind you of anyone?
Namaste … … … … … … … … … … … … … … … … … Mahatma Gandhi … … … … … … … … … …
« We must be the change we wish to see in the world »
« There is a sufficiency in the world for man's need but not for man's greed »
Congress, over the last 12 years or so has gutted all of our watchdog and social welfare programs in order to spend more and more money on "defense". Today we spend over half of our anual fiscal budget on military programs. These agencies don't have the funding or the manpower to do more than a token inspections.
Fund peace, nor war.
Vote for Kucinich!
Overheard in the US twenty years from now:
'Don't need me no bath. Bathing makes ya weak, and hain't no such things as germs. Hit's all evil spirits sent by them devil worshiping Ay-rabs over in the oilpatch where our brave boys is supportin' D'mockerasee...'
Max profits coupled with "virtually" zero impacts.
Too bad we live in this other world, associated with reality, that has real impacts.
Namaste … … … … … … … … … … … … … … … … … Mahatma Gandhi … … … … … … … … … …
« We must be the change we wish to see in the world »
« There is a sufficiency in the world for man's need but not for man's greed »
Corporations want zero regulation, zero oversight, and zero accountability.
So, the FDA is doing exactly what the corporate politicians want it to do. Nothing. From that point of view, it's an extremely successful agency.
Bush says we are safer from terrorism, but what are your chances on being caught by a terrorist in comparison to having dangerous medicine, toys, pet food, bad water, bad air, bad roads, etc. put you in a danger? Much more likely
Wow, a group of corporate types were this critical of the big Pharma-loving FDA; can you imagine how bad the situation must really be?