Medical treatments that are intended to repair or replace damaged cells, tissues, or organs make up the field of regenerative medicine. Examples include stem cell therapies, tissue grafts, and organ transplants.
The field has great potential, but as the U.S. Food and Drug Administration noted last year, “A small number of unscrupulous actors … have seized on the clinical promise of regenerative medicine” to offer patients unproven treatments. FDA and other regulators and stakeholders face a challenge to provide adequate assurances of safety and efficacy for these therapies without stifling their practice and development.
This white paper, commissioned by The Pew Charitable Trusts and prepared by Sidley Austin LLP, provides background on the legal and regulatory framework governing regenerative medicine, the history of how it has been implemented and enforced by regulators, and the current legal landscape for these treatments.