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Document Type

Article

Abstract

Regenerative medicine is defined as the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells or tissues. It includes a variety of approaches, such as transplanting cells to promote healing, editing genes in cells to attack cancer, and even building organs from biological materials. Regulating regenerative medicine therapies is no easy task. Finding a balance between competing interests–enabling timely access for needy patients while simultaneously ensuring a positive benefit/risk profile and promoting the development of beneficial innovations–is hard enough at any given point in time. But add in constantly advancing scientific knowledge and increasing commercialization opportunities, and the regulatory system struggles to keep pace.

As new potential therapies have emerged and challenged the existing regulatory structure, stakeholders have prodded Congress and the Food and Drug Administration (FDA) for reforms to make the pathway to the marketplace less rigorous. These efforts include enacted laws, such as a regenerative medicine provision in the 21st Century Cures Act, congressional bills that have been introduced but died, and policy whitepapers. But others oppose loosening the regulatory framework and argue that the current level of premarket testing for safety and efficacy is needed both to ensure public health and to advance the field of regenerative medicine by generating important clinical data. Still others advocate for a middle path that advances some therapies while protecting the public from the most egregious risks. I evaluate these reform proposals based on the dual goals of regulating medical products based on risk: protecting the public by limiting access to therapies where the risks outweigh the benefits, and promoting innovations that improve public health.

This Article first argues that proposals to speed FDA approval through adaptive licensing are premature. Second, the Article considers reform proposals for low and moderate-risk regenerative medicine therapies. Based on recent scientific literature, the Article argues that the current laws and regulations set an appropriate framework for the regulation of regenerative medicine therapies and support incremental reforms.

This Article has four parts. Part I describes the regenerative medicine industry and the existing federal regulatory structure that governs regenerative medicine therapies. Part II addresses the need for regulation as well as the critiques of the current framework. Part III analyzes proposals for progressive licensing of higher-risk regenerative medicine therapies regulated as biologics. Part IV evaluates reforms for regenerative medicine therapies regulated as human cell and tissue products.

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