The Social Production of Evidence: Regenerative Medicine and the 21st Century Cures Act

Abstract

Regenerative medicine (RM) has experienced uncertainty in regulatory review since the beginning. Political and social environments always affect policy: consistency and interoperability across societies has been hard to achieve, and over time, extreme precaution has largely been replaced with optimism and high expectations from patients, politicians and investors. Like all novel therapies, disputes about what sort of evidence matters and how it should best be produced dogged the field's early days. With little expertise from regulators or industry, and few standards to go on, safety and effectiveness requirements were negotiated. More recently, assumptions about what counts as acceptable evidence are being up-ended in light of new tools and techniques for the collection and analysis of data, but also decades of discontent with evidence-based medicine (EBM). Patients are also demanding to have a say in clinical research and may be willing to take greater risks. All this is happening in a political climate in which funding is being cut for scientific research and governmental oversight.