(University of Oregon Law School, 2009) Page, Christopher R.
In light of the current regulatory climate, this Comment argues for
a new approach to the regulation of prescription drugs approved by
the FDA for general sale. The author proposes a reorganization of the
agency resulting in the creation of a division of the FDA that focuses
solely on actively making regulatory decisions regarding postapproval
pharmaceutical products. This new division should be granted the
power to effectively gather information and enforce regulations
against pharmaceutical companies without needing to consult with another agency or FDA division. The use of this power by a new
division would significantly ameliorate much of the public distrust
discussed previously.
