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From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access, Seema Shah, Patricia Zettler

Yale Journal of Health Policy, Law, and Ethics

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, not courts, 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, and many of the proposals to …