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Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters
Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters
Indiana Law Journal
Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened.
This Article analyzes two examples of FDA inertia and compares …