President Biden is expected to quadruple tariffs on electric vehicles from China in an announcement Tuesday, according to a source familiar with the decision.
That’s simply not true. Scale up and manufacturing of even the simplest small-molecule drugs even after all the clinical research has been completed is incredibly complex and hard to manufacture consistently, let alone replicate.
Even with access to all the research and manufacturing and quality testing procedures and records of a successfully manufactured drug (which a generic competitor would not have), I have seen and been part of an expansion facility at the very same location using the exact same raw material suppliers and exact same serial # equipment and even the same cleaning and manufacturing and quality testing lab employees just moved into a new building, take years and dozens of batches to get to the same level of consistent safety, identity, strength, purity, and quality as the previous manufacturing line after it was shut down to make room for a newer product. I’ve seen final product yield drop by nearly half from batch to batch just because the supplier of one raw material used as an excipient switched their own manufacturing process to make a powder slightly more consistently fine-grained and the mixing process no longer worked the same - and it took months of investigation to figure that out, plus much more time and money to find a solution and demonstrate it didn’t change the final product over the next three batches (a regulatory requirement).
Change over to modern large-molecule biologics where you have to grow them up in bioreactors, and things get a lot more complex to get it right and even harder to get consistent. You can’t just follow a recipe and double the ingredients to get twice the product.
Consider an extremely common drug like levothyroxine that’s been around for nearly a century and has many generic manufacturers because it’s one of the “easiest” and most well-understood essential drugs to make. It has such a low therapeutic window that the exact same process between two manufacturers, using the exact same raw material suppliers, passing testing with the exact same results, can result in such drastically inconsistent levels in the same patient at the exact same dose that many people are unable to switch from a one generic or brand manufacturer to another once their doctor has managed to find the right dose to keep their T4 levels stable. Something as mundane as the shape of the tablet press can make a huge difference even when dissolution is the same.
You said, it is easy and inexpensive to manufacture generics and that the expense for drug production goes into research.
Did you not read the article you linked, or did you just not read my comment before downvoting it? It says the exact same thing in the “Controversies in FDA Bioequivalence Testing” section about the efficacy of the drug I listed as a specific example of generics not actually showing bioequivalence…TSH, free T4, and T3 in the blood are how the efficacy of levothyroxine is measured. Here, I’ll quote it for you.
Unresolved concerns surrounding bioequivalence undermine patients’ and health care providers’ confidence in making generic substitutions. Bioequivalence studies do not assess clinical or surrogate markers that directly correlate with efficacy and/or toxicity (e.g., thyroid-stimulating hormone [TSH], seizures, transplant rejection, international normalized ratio). In addition, manufacturers do not undertake comparative studies against other generic products with the same active ingredient, yet the FDA maintains that all approved generic medications are bioequivalent
That’s simply not true. Scale up and manufacturing of even the simplest small-molecule drugs even after all the clinical research has been completed is incredibly complex and hard to manufacture consistently, let alone replicate.
Even with access to all the research and manufacturing and quality testing procedures and records of a successfully manufactured drug (which a generic competitor would not have), I have seen and been part of an expansion facility at the very same location using the exact same raw material suppliers and exact same serial # equipment and even the same cleaning and manufacturing and quality testing lab employees just moved into a new building, take years and dozens of batches to get to the same level of consistent safety, identity, strength, purity, and quality as the previous manufacturing line after it was shut down to make room for a newer product. I’ve seen final product yield drop by nearly half from batch to batch just because the supplier of one raw material used as an excipient switched their own manufacturing process to make a powder slightly more consistently fine-grained and the mixing process no longer worked the same - and it took months of investigation to figure that out, plus much more time and money to find a solution and demonstrate it didn’t change the final product over the next three batches (a regulatory requirement).
Change over to modern large-molecule biologics where you have to grow them up in bioreactors, and things get a lot more complex to get it right and even harder to get consistent. You can’t just follow a recipe and double the ingredients to get twice the product.
Consider an extremely common drug like levothyroxine that’s been around for nearly a century and has many generic manufacturers because it’s one of the “easiest” and most well-understood essential drugs to make. It has such a low therapeutic window that the exact same process between two manufacturers, using the exact same raw material suppliers, passing testing with the exact same results, can result in such drastically inconsistent levels in the same patient at the exact same dose that many people are unable to switch from a one generic or brand manufacturer to another once their doctor has managed to find the right dose to keep their T4 levels stable. Something as mundane as the shape of the tablet press can make a huge difference even when dissolution is the same.
It’s not at all easy to manufacture drugs.
Yeah, because generics don’t save patients hundreds of billions of dollars…
https://www.uspharmacist.com/article/how-generic-drugs-are-made
You said, it is easy and inexpensive to manufacture generics and that the expense for drug production goes into research.
Did you not read the article you linked, or did you just not read my comment before downvoting it? It says the exact same thing in the “Controversies in FDA Bioequivalence Testing” section about the efficacy of the drug I listed as a specific example of generics not actually showing bioequivalence…TSH, free T4, and T3 in the blood are how the efficacy of levothyroxine is measured. Here, I’ll quote it for you.