Under the healthcare reform of 2010, the FDA was given the authority to regulate generic versions of genetically engineered (GE) drugs. Furthermore, some genetically engineered drugs may not even receive human or animal testing — it all depends on whether or not the FDA deems it necessary.
The FDA is proposing new guidelines — an ‘abbreviated pathway’ — for generic drug makers to make similar, but not necessarily identical, generic drugs called ‘biosimilars’. The FDA will accept the drug studies from the original GE drug for approval, and will only require animal or human testing if the FDA deems it appropriate. This policy is greatly lacking because the ingredients and amounts of the ingredients may be different. Never mind that GE product testing standards are woefully deficient to begin with, especially regarding long-term organ damage and other dangers. Or that different ingredients may have a negative synergistic effects.
The excuse given for this new policy is to open competition in the free market, which is quite hard to believe as Big Pharma monopolies control healthcare in America and cost-effective natural therapies are unfairly maligned. The government is really boosting the GE biotech drug market which was valued at $243 million in 2010 and is expected to grow to $3.7 billion in sales by 2015. The government says that GE generic biosimilars will save them $25 billion over 10 years.
Ironically, GE biotech drug makers even argued against GE biosimilar generic drugs, saying that the formulas were too complex to duplicate, but meanwhile they are simultaneously pursuing copy-cats of their competitor’s GE drugs. There is a lot of money to be made in the GE drug market. For example, Roche’s Avastin (a GE biotech cancer drug) costs $100,000 a year. Amazingly, people are paying these high prices of cancer drugs that have been found in the past to be not only ineffective, but kill the patient more quickly.
It seems quite apparent that the FDA is ignoring the established longterm risks that go along with genetic engineering (and even many common drugs), and unloading them on the public to boost sales — all without necessary animal and human trial!
5 thoughts on “Genetically Engineered Generic Drugs to Be Unleashed Without Mandatory Testing”
To quote an old saying "somethin' ain't kosher" with this deal. It does not sound good at all!!A wild thought would be,that it could be an attempt to lower the population,especially the older generation. Just a thought!!This, because of the oddballs in Washington–especially one!!
Same old same old. FDA is more interested in protecting drug industry profits than it is in protecting the public.
There are natural supplements for many things that are as effective as patent drugs, but much more cheaply and without the toxic side effects. And yet the FDA is doing everything it can to try to put a damper on them.
Tampering with genes is the most dangerous thing man has done since inventing the atom bomb. Maybe more so, as these genetic modifications, once released into the environment, have the potential to corrupt the entire gene pool around the world. Nobody can possibly know what the long term effects of these GE products will be, and the FDA is going to allow their release without even testing them? God forbid!
I think you gentlemen are both correct, unfortunately. I think the FDA/gov't. has turned against the people and this is nothing short of annilihation of the human race…..
My hope is that unlike the hidden assault on the food chain through GMO, attack on nature can be avoided with labeling.
"The government says that GE generic biosimilars will save them $25 billion over 10 years."
The only way they will save is that the GE biosimilars will probably kill people before causing greater organ damage that would be costly to treat.
Sad situation that we the people have allowed ourselves to be put in.