You can try to fudge your data but the FDA is the most rigorous science based regulator in America and possibly the world.
And, the FDA monitoring of drugs requires more than Phase 1-3 clinical trials (which cost hundreds of millions of dollars to produce some of the most rigorous science in human history), but they also do post-release data analysis (so called Phase 4), and have even recently pulled drugs which are not meeting the Phase 2 and 3 standards for safety and efficacy over existing treatments (not efficacy over placebo, the results must show efficacy also over existing drugs).
Not to mention, the FDA fines of pharma corporations are some of the largest fines in American history.
So with the FDA you have
* A regulator using science forcing big business to spend 10 years creating scientific evidence that their product is safe and effective. No other industry on the planet has these requirements.
* A regulator using market data to actively govern products and pull products which aren't safe and effect (pretty normal)
You might find this surprising but pharmaceuticals is a money losing industry in the long term. Most of these companies are looking pretty bad, they're spinning off any division which could potentially be profitable (biologics, medical devices maybe) but your average business of finding new drugs? It's not profitable, the regulation is so intense and the work is so hard and competition which ignores intellectual property is so damaging that it's very likely most major pharma companies will go bankrupt in the coming decades.
When you compare how much science the FDA makes drug companies do to any other industry, food, finance, supplements, makeup, cars, houses, anything at all... nothing else compares. A forensic audit is nothing compared to a Phase 3 clinical trial. Far less goes into proving a car is safe than a drug. Etc.
The FDA is doing incredible scientific work with an extremely thin budget.
And, the FDA monitoring of drugs requires more than Phase 1-3 clinical trials (which cost hundreds of millions of dollars to produce some of the most rigorous science in human history), but they also do post-release data analysis (so called Phase 4), and have even recently pulled drugs which are not meeting the Phase 2 and 3 standards for safety and efficacy over existing treatments (not efficacy over placebo, the results must show efficacy also over existing drugs).
Not to mention, the FDA fines of pharma corporations are some of the largest fines in American history.
So with the FDA you have
* A regulator using science forcing big business to spend 10 years creating scientific evidence that their product is safe and effective. No other industry on the planet has these requirements.
* A regulator using market data to actively govern products and pull products which aren't safe and effect (pretty normal)
* A regulator assessing multi-billion dollar fines pretty regularly https://en.wikipedia.org/wiki/List_of_largest_pharmaceutical...
You might find this surprising but pharmaceuticals is a money losing industry in the long term. Most of these companies are looking pretty bad, they're spinning off any division which could potentially be profitable (biologics, medical devices maybe) but your average business of finding new drugs? It's not profitable, the regulation is so intense and the work is so hard and competition which ignores intellectual property is so damaging that it's very likely most major pharma companies will go bankrupt in the coming decades.
When you compare how much science the FDA makes drug companies do to any other industry, food, finance, supplements, makeup, cars, houses, anything at all... nothing else compares. A forensic audit is nothing compared to a Phase 3 clinical trial. Far less goes into proving a car is safe than a drug. Etc.
The FDA is doing incredible scientific work with an extremely thin budget.