> The point was that people are up in arms about either outcome: FDA denies approval, people get angry. FDA allows approval, people get angry.
What people want is approval through a fair, orderly process.
If the tests and reports and expert opinions and panel decisions are needed, their results should be respected - for every drug maker.
If the tests and reports &c. aren't needed - they shouldn't be required.
If there's some more nuanced approach required, like experimental exceptions for drugs specifically for people who are otherwise terminally ill, it should be codified.
The approach of "spend a load of money on studies, then maybe the boss ignores the results" seems very open to corruption.
What people want is approval through a fair, orderly process.
If the tests and reports and expert opinions and panel decisions are needed, their results should be respected - for every drug maker.
If the tests and reports &c. aren't needed - they shouldn't be required.
If there's some more nuanced approach required, like experimental exceptions for drugs specifically for people who are otherwise terminally ill, it should be codified.
The approach of "spend a load of money on studies, then maybe the boss ignores the results" seems very open to corruption.