Publication Title
Yale Journal of Health Policy, Law, and Ethics
Document Type
Article
Publication Date
2010
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.
Recommended Citation
Seema Shah & Patricia Zettler, From a Constitutional Right to a Policy of Exceptions: Abigail Alliance and the Future of Access to Experimental Therapy, 10 Yale J. Health Pol'y, L. & Ethics 135 (2010).
Institutional Repository Citation
Patricia J. Zettler & Seema K. Shah,
From a Constitutional Right to a Policy of Exceptions: Abigail Alliance and the Future of Access to Experimental Therapy,
Faculty Publications By Year
2028
(2010)
https://readingroom.law.gsu.edu/faculty_pub/2028
Volume
10
Issue
1
First Page
135
Last Page
196
Included in
Administrative Law Commons, Bioethics and Medical Ethics Commons, Food and Drug Law Commons, Health Law and Policy Commons, Science and Technology Law Commons
Comments
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