mouton29

Dendreon: Don't Forget About Risk vs. Reward

The point is clear enough but since this argument about "changing the question" is a common one, I think it is worth flogging a bit more.

The question was clarified, as Keith says, to reflect (i) the language in the FDA's statutory mandate and (ii) to reflect the phrasing that has used been in all prior examples I could find on the FDA website. Specifically, 21 USC 355(d)((5) permits the FDA to refuse an application if it finds that "there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof..."

Thus, the FDA seeks to determine whether the evidence establishes efficacy, but that standard for that is whether there is "substantial evidence."

What happened at the hearing might be likened to a civil trial in which the judge initially instructs the jury to determine whether the plaintiff should prevail in, say, a wrongful death action. The jury makes it clear in their deliberations that they think this means that they must find that the defendant is guilty "beyond a reasonable doubt." The judge clarifies and instructs them that no, as this is a civil trial, the legal standard is, that the plaintiff must establish his case by a preponderence of the evidence.