[Aurornis]

The point was that people are up in arms about either outcome: FDA denies approval, people get angry. FDA allows approval, people get angry.

> The real problem is that it costs too much to bring new treatments through a clinical trial

As opposed to what? Just letting anything go? We basically have that situation in the alternative medicine world and the grifters are out in full force peddling things that we know don’t work the way they claim. Imagine how bad it would be if we waived away clinical trial requirements.

[michaelt]

> 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.

[jostmey]

Finding ways to reduce the costs of a clinical trial does not mean abandoning clinical trials (or something sufficiently similar)

[inglor_cz]

At the very least, FDA should allow use of medications that were approved in Japan or the EU.

Requiring separate US clinical trials is an unnecessary burden for the manufacturer, and will likely result in higher prices or unavailability of some medications.

Even in programming we frown upon "reinventing the wheel". This is reinventing the wheel with a fantastic price tag.