There is something which is very hard to estimate about drug regulation.

It's relatively easy to estimate how much the regulation costs in added delay, and the amount of lives that could be saved if the (finally found to be efficient) drug was available earlier.

It's a bit harder, but still possible, to estimate how much the regulation protects by looking at the drugs that were finally found to be dangerous, and estimating how much people they would have killed or damaged if they would have been released.

But it's almost impossible to estimate how much the existing regulation will make the drug corporations to change their own internal practice. That's the most efficient kind of regulations : regulation that, most of the time, aren't enforced by cops and courts, but by people directly. Drug companies taking more care about preventing side-effects in the drugs in the whole process, just because they know that at the end the FDA will veto a drug that's too dangerous.

Like with traffic regulation : the real effect of speed limits and red light is not measured by the number of people who end up being without a drivers' license because they got caught too many times, and can't endanger others anymore. But about the people who respect the red light and speed limits because of the law, but wouldn't without it. And it's very hard to estimate those.