The book in question was unusually well written. Read it cover to cover the first time I picked it up.
TLDR- The active ingredients for most of the US generic drug supply come from India and China. The labs and factories in those countries have an agreement where they are held to the same standards the FDA holds US companies to. The only difference is that know ahead of time when inspections happen and do things by the book while the FDA people are inspecting- the rest of the year is total chaos. As a result our generic drug supply has poor quality active ingredients, is not absorbed into the body in the same way and so much active ingredients for NAME BRAND medications come from these same shoddy factories that we can't even really trust a lot of the medications we are taking these days. Fun stuff.
In other words, it is a hit piece to spread FUD against the indian pharmaceutical and biotech industry that is one of the largest and cheapest suppliers of generic drugs to the world.
Instead of focusing on the regulator and the greed of ethically and morally dubious capitalists, this seems an attempt to deliberately tarnish the reputation of the whole industry.
Big Pharma has an axe to grind with India and China. After all, how is it "capitalism" when India produces and charges only 4% of Big Pharma's price for an HIV drug instead of colluding with them to sell the same drugs for a huge profit? /s
Paywalled. Why? The drug matter isn’t there? There are duff components included with the proper drug matter? The pill colour and logo are wrong?
The patent and the countries drug agency describes how to make the thing. Once off patent this becomes a recipe. Harder for biologics, though. Note that many of the patented drugs are made off shore using outsourced chemistry and materials.
A major thrust of the book is that once off-patent, others can copy a drug -- but the actual process for creating it is not in the patent. The ingredients are, and it's up to the generic manufacturers to create a set of manufacturing steps that result in the same biological impact. An analogy would be getting the ingredients list for a cake, but not the assembly steps.
The manufacturers also need to prove that the impact is the same, but used fabricated evidence to do so. They also operate plants that are not subject to random inspection -- FDA inspections in foreign countries are pre-announced for political and visa reasons, and are under-staffed, leading to additional fraud.
There really are many situations where it works as intended, and FDA also prevents and pre-empts abuses, they just don't get credit for it publicly. I expect they get credit publicly in places few people ever look, like their website.
And, then, there's cases that undermine trust, like OxyContin, specifically accepting Purdue's claim that seven equals twelve.
I learned long ago that I needed to take my health in my own hands and that the FDA was an adversarial force.
I had to face decades of incarceration to access the medicine that would eventually save and transform my life — through an underground provider who was risking the same.
I went on to spend a number of years helping dozens of others do the same.
I’m curious what your story has to do with the fda. If you Are dealing with schedule 1 materials, aren’t they written into law by Congress, not the fda?
You’re probably right, but makes me wonder if it could be an abortion pill or a pricey treatment like hepC treatment.
Or something schedule 2+ and used a little too off-label for insurance to cover it because the fda won’t let it be labelled for OP’s use. But an underground provider might prescribe it the “approved” way.
TLDR- The active ingredients for most of the US generic drug supply come from India and China. The labs and factories in those countries have an agreement where they are held to the same standards the FDA holds US companies to. The only difference is that know ahead of time when inspections happen and do things by the book while the FDA people are inspecting- the rest of the year is total chaos. As a result our generic drug supply has poor quality active ingredients, is not absorbed into the body in the same way and so much active ingredients for NAME BRAND medications come from these same shoddy factories that we can't even really trust a lot of the medications we are taking these days. Fun stuff.