Simple really. Establish an independent entity to conduct them, and fund those activities as part of the approval process.
Having a vested interest control scientific studies is poor regulatory system design.
Having a vested interest control scientific studies is poor regulatory system design.
Also, drug companies often hire physicians and researchers (often the best ones) to help with drug development far before any trial is run. Would you like to exclude those experts from input on the trial design?
From your comment I get the sense you have a limited understanding of what is really involved in drug development.
However you appear to have retired undefeated as devil's advocate, as if the questions you put are unanswerable.
I would admit that there are more questions and answers that need to be given before we fully implement my HN comment, but that is hardly a refutation of the core idea: that a system free of conflict-of-interest requires independent entities and umpires that are more empowered than the conflicted interests in that system.
A recent Forbes opinion piece has its own take on inserting independent entities into the system [0]:
What we need is a construct with teeth, an established network of industry-independent researchers (not contractors) equipped to evaluate trial design, statistical power, data analysis, and interpretation, not as regulators but as contributors to final research publications. It would be a sort of Congressional Budget Office for clinical trial results.
Admittedly the position outlined in that article does not go as far as a completely independent entity operating all clinical trials for the purposes of regulatory approval, but it's in the right direction.
[0] http://www.forbes.com/sites/emilywillingham/2012/11/26/how-c...
For example, Pfizer was found guilty of promoting Bextra off label, a very serious charge from the viewpoint of the FDA and the Justice Department. Punishment includes banning companies from doing business with CMS (who run Medicare and Medicaid).
Pfizer entered into an agreement with the Justice Department/HHS where a shell company was allowed to plead guilty and be banned from doing business with Medicare. That's right, a shell company that doesn't actually sell any drugs.
http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/index.htm...
I'd agree the unwillingness of the gov't to use the powers it has is a problem. But that's a separate and equally important issue that others in this thread have flagged, filed under the label 'regulatory capture'.
It's not a situation that requires fire and brimstone and outrage. It should just be approached with dispassionate understanding: we have a defective system that is not designed to withstand attacks by self-interested system 'hackers'.
The solution is to design a system that neutralises short-term, narrow self-interest.
Publishing every single trial will probably also make more expensive.