Approval process lowers the number of kids on atypical precriptions (St. Petersburg Times)

None of the atypicals have been approved by the FDA for use on
preschoolers, and Florida Medicaid guidelines recommend they be used on this age
group “only in the most extraordinary of circumstances.” But those warnings
didn’t slow a tsunami of atypical prescribing. Between 2001 and 2004, the number
of kids under 6 taking atypicals increased 300 percent. For all youths under 19,
the increase was about 250 percent.

Memos show FDAers fought preemption

Jane Axelrad, FDA’s associate director of CDER at the time, wrote that, “we
usually find ourselves dealing with situations where sponsors want to minimize
the risk information.” According to Axelrad, preemption wouldn’t be “consistent
with the agency’s role in protecting the public health.” …