The FDA exists because before those regulations were a thing, there were scandals such as the Elixir Sulfanilamide poisoning deaths in 1937:
https://en.wikipedia.org/wiki/Elixir_Sulfanilamide
... And then tighter regulations were required for testing new medicines, after incidents such as the Thalidomide birth defects scandal:
https://en.wikipedia.org/wiki/Thalidomide#Birth_defect_crisi...
Having a regulatory framework for the pharmaceutical industry is essential to public safety. But the framework we currently have, as it has evolved, isn't fit for purpose any more.
Regulating drug development is a complex problem, and the people best qualified to supervise the approvals/licensing process are typically folks who've worked in the industry. But this opens the system up to Regulatory Capture:
https://en.wikipedia.org/wiki/Regulatory_capture
TLDR is, you get a revolving door between the regulated industry and the regulators, and the regulators are co-opted into maintaining barriers to entry that keep insurgents out (thereby providing a profitable oligopoly to their former -- and usually future -- employers).
There is also a toxic interaction with the WTO-endorsed patent system, which is w-a-y too complex to get into in this comment but which ensures that new antibiotics (which we desperately need) are unprofitable but the price of drugs that are decades out of their original patent coverage (such as insulin) can be made to spiral profitably by tweaking the intellectual property playing field.
I'm sorry, but I don't have a simple/easy answer for this: it's a really gnarly problem that will require not only legislation but international treaty negotiations to mitigate, and simplistic attempts to cut the red tape are likely to lead to snake oil scandals and, quite possibly, a considerable death toll, not just new breakthrough treatments.
https://en.wikipedia.org/wiki/Elixir_Sulfanilamide
... And then tighter regulations were required for testing new medicines, after incidents such as the Thalidomide birth defects scandal:
https://en.wikipedia.org/wiki/Thalidomide#Birth_defect_crisi...
Having a regulatory framework for the pharmaceutical industry is essential to public safety. But the framework we currently have, as it has evolved, isn't fit for purpose any more.
Regulating drug development is a complex problem, and the people best qualified to supervise the approvals/licensing process are typically folks who've worked in the industry. But this opens the system up to Regulatory Capture:
https://en.wikipedia.org/wiki/Regulatory_capture
TLDR is, you get a revolving door between the regulated industry and the regulators, and the regulators are co-opted into maintaining barriers to entry that keep insurgents out (thereby providing a profitable oligopoly to their former -- and usually future -- employers).
There is also a toxic interaction with the WTO-endorsed patent system, which is w-a-y too complex to get into in this comment but which ensures that new antibiotics (which we desperately need) are unprofitable but the price of drugs that are decades out of their original patent coverage (such as insulin) can be made to spiral profitably by tweaking the intellectual property playing field.
I'm sorry, but I don't have a simple/easy answer for this: it's a really gnarly problem that will require not only legislation but international treaty negotiations to mitigate, and simplistic attempts to cut the red tape are likely to lead to snake oil scandals and, quite possibly, a considerable death toll, not just new breakthrough treatments.