Regulating (for the Benefit of) Future Persons: A Different Perspective on the FDA's Jurisdiction to Regulate Human Reproductive Cloning

Publication Date: January 2003

Publisher: S.J. Quinney College of Law

Author(s): Gail H. Javitt; Kathy Hudson

Research Area: Health; Law and ethics

Keywords: Food and Drug Administation; Reproductive genetics; Cloning

Type: Other

Coverage: United States

Abstract:

The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning.

This Article argues that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born.

This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.

In Utah Law Review, no.4 2003, p.1201-1229.