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

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