Regular megapharm medicine takes time in the development for quite straight-forward reasons: you need an idea; you need some chemical or biochemical leads; you need to test out your best ideas against The Evidence; until you can convince the money-people in your company to fund a big study . . . in mice; and two blinks later two years have passed and $10,000,000 has been 'burnt' and your not even on human trials. At each stage in this development process promising leads will crash and burn and you have to start again. Or at least retreat several steps and try a different direction. The deeper everyone gets in, the more temptation there is to massage the data into a more positive state
At some stage, the Feds get involved in a quite confrontational way: you have to prove that your new meds are a) safe and b) efficacious. By the time the new therapy is ready for the big launch, and all your drug reps are primed with brochures, the company has spent $1.2 billion [average cost of pipeline] and more than half of the patent window has expired. No wonder drugs cost so much. Statins, which give some slight benefits against heart attack can be sold to millions of fat white Westerners . . . for the rest of their lives; so the $1.2bn is spread over a
With generic medicines, the challenges are different and, according to what I heard in Wexford, peculiar. When you apply for a licence to sell a generic drug you have to show that your yellow-pack product has precisely the same effect as the just off-patent original. There's a whole other palaver if your reverse engineered medication is better than the original. That led to a whole discussion about how hard it is to follow the instructions to make a rip-off. The thing about patents is that they are 'open': patent ductus arteriosus is a congenital disease which manifest as an open hole between two blood-vessels that should be closed. Patents are a deal struck between creators of intellectual property and the community. The patent owners set out in detail what they have discovered and in return get exclusive access to the new idea for a set period of time.
It's devilish difficult to follow the protocol and make a copy-cat drug. It's the same as the Materials & Methods section of a scientific paper: this should contain just enough detail that a rival who is skeptical about your results can precisely follow your process to replicate the experiment and see if s/he gets the same result. Many's the time in my days in a real immunology lab when the Effectives couldn't get the some new protocol to work, no matter how closely they followed the M&M. A visit to the lab which wrote the original paper often cleared the log-jam: a key nugget of information - too 'obvious' to state explicitly - never made it to the printed page.
And everyone, except the Feds, is in it for profit. MegaPharm and YellowPack both want a return on their investment, so they pay their employees as little as possible and charge whatever the market will bear. The first generic to market tends to charge 3/4 of the price of the original although their costs are lower [no original ideas to have, test and cull for starters]. Eventually The Market will force down the price as more competitors pass through the FDA. Apparently, the production facilities don't easily get shipped to India because there is that magic, barely quantifiable, know-how that makes one factory able to produce the goods reliably. And the inside advice is do not buy drugs over the internet. There are coliform bacteria on those cheap shirts you buy in the local store, because the hand-washing facilities are not-so-good in Bangladesh, but you don't pop them in your mouth