Many, many observers have noticed that the risk assessment process within the FDA is something like this:
15,000 people die of a disease while a treatment is in the paper pushing process - “well, good science takes time, don’t you know? You’ll just have to be understanding.”
15 people die of an unexpected reaction to a treatment while 14,985 have their lives saved - “OMGWTFBBQ, someone did not review this thoroughly enough, heads must roll!!!”
Change is needed.
