Oregon Law Review : Vol. 88 No. 4, p. 1189-1220 : These Statements Have Not Been Approved by the FDA: Improving the Postapproval Regulation of Prescription Drugs
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.