As much as I hate regulation, there would have to be something around this.  Independent verification of results, including autopsies by approved facilities, as well as a limit on patient cost would probably be called for.  In exchange we could allow the FDA to prioritize results from these tests to get the drug approved more quickly.    I personally think the FDA should be voluntary but getting FDA approval should also provide better protection against lawsuits.  I mean, if the possible side effects says heart attack and you have one why should you be able to sue?