Intractable Delay and the Need to Amend the Petition Provisions of the FDCA

43 Pages Posted: 23 Mar 2014 Last revised: 16 Jun 2015

See all articles by Diana R. H. Winters

Diana R. H. Winters

Indiana University Robert H. McKinney School of Law

Date Written: March 3, 2014

Abstract

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 private enforcement under the Food, Drug, and Cosmetic Act (FDCA) to more successful private party activity under several environmental statutes. These comparisons highlight several weak spots in the FDCA that contribute to the difficulties faced by private party oversight in attempting to compel FDA action. The Article then proposes solutions suggested by these problems. Congress should amend the Act to include more specific petition provisions with statutory deadlines and to strengthen the general citizen petition provision of the FDCA. Interested parties should also be able to petition the Office of Information and Regulatory Affairs (OIRA) for the review of the denial of rulemakings. These steps will restore the vitality of a critical part of the administrative enforcement scheme — private party oversight — and thereby benefit both the public health and the regulatory state.

Keywords: Food and drug law, environmental law, administrative law

Suggested Citation

Winters, Diana R. H., Intractable Delay and the Need to Amend the Petition Provisions of the FDCA (March 3, 2014). 90 Ind. L.J. 1047 (2015); Indiana University Robert H. McKinney School of Law Research Paper No. 2014-8. Available at SSRN: https://ssrn.com/abstract=2412662

Diana R. H. Winters (Contact Author)

Indiana University Robert H. McKinney School of Law ( email )

530 West New York Street
Indianapolis, IN 46202
United States

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