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!