Reforming Regenerative Medicine Regulation

Abstract

The FDA’s regulation of regenerative medicine therapies, such as stem cell treatments, bioengineering and cell and tissue therapies, is an area of intense interest in Congress and the FDA and is the subject of current reform proposals. Vocal critics of the FDA’s current regulatory structure assert contradictory charges: some complain that the FDA over-regulates regenerative medicine therapies thereby impeding innovation and harming needy patients, while others charge that the FDA’s regulation is too loose and allows unsafe products to reach the marketplace. This article evaluates recent reform proposals that have arisen in proposed bills, policy reports, and public hearings. Relying on the recent scientific literature on regenerative medicine therapies, I argue that the FDA should incrementally reform its regulation of moderate-risk products to address technological and scientific developments, but that proposals to overhaul the regulation of higher-risk regenerative medicine therapies are unworkable and normatively unwise. The main thrust of these proposals is permit early licensing based on less robust clinical evidence but require substantial post-marketing studies. By applying a theoretical framework on iterative regulatory action that first arose in environmental law, I conclude that the current regime leads to a superior balance between the FDA’s dual goals of protecting public health and encouraging innovation.

Keywords: Regenerative, RMAT, FDA, Stem Cell, Progressive, Iterative