Friday, January 20, 2017

FDA Writes Very Rapid Report on Drugs that Crashed in Phase III - AKA Why We Need FDA

Since mid November, some of the possible candidates for head of FDA have been long time advocates of a more libertarian stance, "let the market decide," not the FDA.

FDA has just released a detailed and granular 44 page white paper on "22 Case Studies" where drugs worked in Phase 2 but crashed in Phase 3.   That is, FDA argues that rigorous and closely reviewed Phase 3 trials, before market release, kept once-promising drugs from hurting patients through premature access.

The FDA white paper is here.   Coverage at John Carroll's ENDPOINTS is here.

As Carroll notes, the commissioner won't be Califf, as he steps down today.  In contrast, NIH chief Francis Collins remains in place, as least for the near term.

Califf's departure was finalized a few days ago (here, here).