Compassionate Use of Experimental Therapies: Who Should Decide?

4 Pages Posted: 26 Jul 2015 Last revised: 10 Oct 2015

See all articles by Patricia J. Zettler

Patricia J. Zettler

Ohio State University (OSU) - Michael E. Moritz College of Law

Date Written: July 22, 2015

Abstract

In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include more specific criteria for authorizing compassionate use. But even where regulatory agencies make decisions based on clear rules, difficult questions will arise.

Keywords: bioethics, administrative law, regulation, agencies, compassionate use, regenerative medicine, food and drug law, science and technology, stem cell therapy, experimental therapy, experimental medicine

JEL Classification: I10, I28, I29, K00, K32, K23

Suggested Citation

Zettler, Patricia J., Compassionate Use of Experimental Therapies: Who Should Decide? (July 22, 2015). EMBO Molecular Medicine, Vol. 7, No. 10, 2015., Georgia State University College of Law, Legal Studies Research Paper No. 2015-29, Available at SSRN: https://ssrn.com/abstract=2634543

Patricia J. Zettler (Contact Author)

Ohio State University (OSU) - Michael E. Moritz College of Law ( email )

55 West 12th Avenue
Columbus, OH 43210
United States

Do you have a job opening that you would like to promote on SSRN?

Paper statistics

Downloads
33
Abstract Views
631
PlumX Metrics