Like
Prescription Drug User Fee Act (
PDUFA) the
Animal Drug User Fees Act (ADUFA) puts the economy of the FDA and it's duties to the people squarely at odds. And like PDUFA the ADUFA, the big fees are up front on a per item basis.
There is also an annual sponsor fee of $43,900.
The Animal Drug User Fee Act of 2003 (ADUFA), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and authorized FDA to collect fees to support the review of animal drugs. These additional resources support FDA's responsibilities under the Act to ensure that new animal drug products are safe and effective for animals as well as human consumers with respect to animals intended for food consumption.
This one pretty much covers the food supply because everything we eat either eats or gets eaten.
So now you and I are both thinking about not having a hamburger this weekend and wondering if this was the point everything got broken right? Well it's a long story. It was actually already broken at this point, this was just another nail in the coffin.
We have to go all the way back to 1937. The administration of BST was shown to increase the milk yield in
lactating cows by preventing mammary cell death in dairy cattle. Until the 1980s, there was very limited use of the compound in
agriculture as the sole source of the hormone was from bovine
cadavers.
Monsanto developed a
recombinant version of
BST,
brand named Posilac, in 1994,
[4] which is produced through a
genetically engineered E. coli.
Now don't get all crazy because you see E. coli it's a good choice for doing this. I'm not a scientist so I won't try to explain why, trust me it's safe. And according to the FDA rBST is safe too.
But what's with the baby 'r' this is America and we like out acronyms big. The little 'r' stands for
recombinant DNA and it's only a small part of the story. But an important part because the use of cloning is interrelated with Recombinant DNA
In other words they cloned BST, using E. coli as a host. But it was already broken. More or less this statement is true depending on how you want to look at things. But no matter which side of the cloning argument you are on the implications are pretty big.
Monsanto is by far the leading producer of
genetically engineered (GE)
seed, holding 70%–100% market share. Including
Roundup Ready soybean seed. It is the world's leading producer of the
herbicide glyphosate, marketed as "
Roundup".
But this isn't about Monsanto, it's about the FDA and money and ideology.
In January 2005, Monsanto agreed to pay a $1.5m fine for
bribing an Indonesian
official. Monsanto admitted a senior manager at Monsanto directed an Indonesian
consulting firm to give a $50,000 bribe to a high-level official in Indonesia's environment ministry in 2002, in a bid to avoid
Environmental impact assessment on its
genetically modified cotton. Monsanto told the company to disguise an invoice for the bribe as "
consulting fees". Monsanto also has admitted to paying bribes to a number of other high-ranking Indonesian officials between 1997 and 2002. Monsanto faced both
criminal and
civil charges from the
Department of Justice and the
SEC. Monsanto has agreed to pay $1m to the Department of Justice and $500,000 to the
SEC to settle the bribe charge and other related violations.
[23]
Monsanto has a partnership with
BASF's Agricultural Products & Nutrition, supply chemicals for agriculture and animal nutrition. The big push here is
Nutrigenomics. As a point of interest I'll mention here that BASF is a very old and reputable company praised by the Climate Leadership Index for their efforts in problems with climate change and greenhouse gasses in our world.
Under the leadership of
Carl Bosch, BASF founded
IG Farben together with
Hoechst,
Bayer and three other companies, thus losing its independence.
I should probably mention at this point that Monsanto is owned by Bayer.
In 2002 Bayer AG acquired
Aventis CropScience and fused it with their own agrochemicals division (Bayer Pflanzenschutz or "Crop Protection") to form Bayer CropScience. The company is now one of the world's leading innovative
crop science companies in the areas of crop protection (i.e.
pesticides), non-
agricultural pest control,
seeds and
plant biotechnology. In addition to conventional agrochemical business it is involved in
genetic engineering of food. The
Belgian biotech company
Plant Genetic Systems, became part of the company by the acquisition of Aventis CropScience.
Bayer AG sponsored the experiments of
Nazi Dr.
Josef Mengele. In 1956 Fritz ter Meer became chairman of Bayer
after having been sentenced at the
Nuremberg trials to seven years' imprisonment for his part in carrying out experiments on human subjects at
Auschwitz.
Through a confusing series of transactions, the Monsanto that existed from 1901–2000 and the current Monsanto are legally two different corporations. Although they share the same name, corporate headquarters, many of the same executives and other employees, and responsibility for liabilities arising out of its former activities in the industrial chemical business, the agricultural chemicals business is the only segment carried forward from the pre-1997 Monsanto Company to the current Monsanto Company.
These aren't evil companies it's not a great conspiracy. They simply have an ideology that is not compatible with a regulatory system that have anything to do with funding.
Justice
Clarence Thomas worked as an attorney for Monsanto in the 1970s. Thomas wrote the majority opinion in the 2001 Supreme Court decision
J. E. M. AG SUPPLY, INC. V. PIONEER HI-BREDINTERNATIONAL, INC. which found that "newly developed plant breeds are patentable under the general utility patent laws of the United States." This case benefitted all companies which profit from genetically modified crops, of which Monsanto is one of the largest.
[64][65][66]
In August 2006, it became apparent that the United States rice crop had been contaminated with unapproved genetically engineered Bayer CropScience rice as undisclosed amounts were found in commercial rice supplies.
[6]
Michael R. Taylor was an assistant to the F.D.A. commissioner before he left to work for a law firm on gaining F.D.A. approval of Monsanto’s artificial growth hormone in the 1980s. Taylor then became deputy commissioner of the F.D.A. in 1991.
[67]
Dr. Michael A. Friedman was a deputy commissioner of the F.D.A. before he was hired as a senior vice president of Monsanto.
[68]
Linda J. Fisher was an assistant administrator at the E.P.A before she was a vice president at Monsanto from 1995 - 2000. In 2001, Fisher became the deputy administrator of the E.P.A.
[69]
Former Secretary of Defense
Donald Rumsfeld was chairman and chief executive officer of G. D. Searle & Co., which Monsanto purchased in 1985. Rumsfeld personally made at least $12 million USD from the transaction.
[70]
We can literally run the
Small world experiment here forever. But this isn't our cell phones or our automobiles this is our food supply and we should error on the side of caution in it's regard.
The answer to who broke the FDA is, we did.