From a Constitutional Right to a Policy of Exceptions: Abigail Alliance and the Future of Access to Experimental Therapy

73 Pages Posted: 8 Apr 2009

See all articles by Patricia J. Zettler

Patricia J. Zettler

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

Seema K. Shah

National Institutes of Health - Department of Bioethics

Date Written: April 7, 2009

Abstract

Although there has been considerable attention to the plight of terminally ill patients with highly sympathetic constitutional and contractual claims that they should be permitted access to unapproved drugs, courts have been appropriately reluctant to grant such claims. Congress and administrative agencies have the requisite institutional competence to decide complex policy issues related to science and health care such as those involved in establishing an expanded access program. Congress and FDA should allow only limited access to unapproved therapies because there are significant concerns about the safety and efficacy of unapproved drugs. Moreover, many of the proposals to widen access may cause delays to the approval process and increased health care costs that are unlikely to be borne in our current climate. Accordingly, we propose limiting access outside of clinical trials, but expanding eligibility for clinical trials in order to ensure that people receive access in a controlled and systematic manner.

Keywords: Health law, ethics, policy

Suggested Citation

Zettler, Patricia J. and Shah, Seema K., From a Constitutional Right to a Policy of Exceptions: Abigail Alliance and the Future of Access to Experimental Therapy (April 7, 2009). Yake Journal of Health Policy, Law, and Ethics, 2010, Available at SSRN: https://ssrn.com/abstract=1374394

Patricia J. Zettler

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

55 West 12th Avenue
Columbus, OH 43210
United States

Seema K. Shah (Contact Author)

National Institutes of Health - Department of Bioethics ( email )

Warren G. Magnuson Clinical Center
Bethesda, MD 20895-1156
United States

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

Paper statistics

Downloads
93
Abstract Views
1,033
rank
327,900
PlumX Metrics