Diesel Brothers
https://www.duramaxforum.com/threads/‘diesel-brothers’-shop-to-pay-850k-for-violating-clean-air-standards.1006062/#post-12265409?utm_source=threadloom&u
Forum Discussion
I will give you another example where just because a government entity says so does not mean it is for the best. My wife is a senior formulation scientist for a large pharmaceutical company and has to deal with the FDA along with the EU and other countries drug regulators. Due to the FDA's overly strict rules and regulations, the cost for the same medication is exorbitantly high for people in the US versus the rest of the world. The testing requirements and red tape needed just to bring a drug to market is much longer(in years) and increases the time and cost ten or even twenty fold versus other markets.
Not only that, but the added regulation for making the drug is ridiculous too. When making a drug, you generally make them in batches on an assembly line with bulk chemicals. Per regulation, you have to test the quality of these bulk chemicals before they go into the batch. With the EU and other countries regulations, the amount of quality testing required is much less and you only have to test if not used within a certain amount of days so if you run the batch again in a few weeks while the active ingredient is still good, then you don't have to test again. With the FDA, you have a lot more tests(many are redundant) and you have to perform these test every time you make a batch of that product. This is why her company has three shifts of QC labs(about 10-15 people per shift) working around the clock to keep up with these required FDA tests. If they went by the EU test, they would likely only need one shift.
The same goes for quality assurance which is testing after the final product is made. For the EU, there are not as many tests which do not require that many labs to run. For the FDA, there are a lot more tests(again, many are redundant from old laws) and require three shifts of labs to keep up. Just these two things alone(QC and QA testing) increases the cost by a considerable margin on top of the extra tens of millions from the FDA's added testing process before it even gets to the manufacturers stage.
This is why that even though a manufacturer makes the exact same product for oversees markets for much less. They cannot sell it in the US because it does not meet all of the FDA requirements even though it went down the same production line. Many of these FDA requirements are old and outdated, but have never been changed. Instead of looking at the old rules when making new ones, the new ones are made doing the very same thing which creates for a lot of redundancy.
You are seeing a lot of this red tape and regulation with the current corona virus. There is medication that seems to be a cure for it in France that is also used to treat other illnesses. However, due to FDA regulations, this drug will have to go through all of the testing all over again, but this time to specifically treat the new illness. Yes, you heard that right. Even though it was quality assured to treat one illness, it has to go through all of the years of testing and regulation for the new illness in order for it to be prescribed for the new illness. Luckily, the president is cutting this red tape and trying to fast track a process that takes several years into just a few weeks.
All this bureaucracy, wasteful redundancies, politically motivated regulation, and overreach is just not confined to the FDA and EPA either. So no, I don't just take what the EPA says as gospel because I know that while many regulations were made for the betterment of the people, many are not.
Not only that, but the added regulation for making the drug is ridiculous too. When making a drug, you generally make them in batches on an assembly line with bulk chemicals. Per regulation, you have to test the quality of these bulk chemicals before they go into the batch. With the EU and other countries regulations, the amount of quality testing required is much less and you only have to test if not used within a certain amount of days so if you run the batch again in a few weeks while the active ingredient is still good, then you don't have to test again. With the FDA, you have a lot more tests(many are redundant) and you have to perform these test every time you make a batch of that product. This is why her company has three shifts of QC labs(about 10-15 people per shift) working around the clock to keep up with these required FDA tests. If they went by the EU test, they would likely only need one shift.
The same goes for quality assurance which is testing after the final product is made. For the EU, there are not as many tests which do not require that many labs to run. For the FDA, there are a lot more tests(again, many are redundant from old laws) and require three shifts of labs to keep up. Just these two things alone(QC and QA testing) increases the cost by a considerable margin on top of the extra tens of millions from the FDA's added testing process before it even gets to the manufacturers stage.
This is why that even though a manufacturer makes the exact same product for oversees markets for much less. They cannot sell it in the US because it does not meet all of the FDA requirements even though it went down the same production line. Many of these FDA requirements are old and outdated, but have never been changed. Instead of looking at the old rules when making new ones, the new ones are made doing the very same thing which creates for a lot of redundancy.
You are seeing a lot of this red tape and regulation with the current corona virus. There is medication that seems to be a cure for it in France that is also used to treat other illnesses. However, due to FDA regulations, this drug will have to go through all of the testing all over again, but this time to specifically treat the new illness. Yes, you heard that right. Even though it was quality assured to treat one illness, it has to go through all of the years of testing and regulation for the new illness in order for it to be prescribed for the new illness. Luckily, the president is cutting this red tape and trying to fast track a process that takes several years into just a few weeks.
All this bureaucracy, wasteful redundancies, politically motivated regulation, and overreach is just not confined to the FDA and EPA either. So no, I don't just take what the EPA says as gospel because I know that while many regulations were made for the betterment of the people, many are not.
