Right to Experimental Treatment: FDA New Drug Approval, Constitutional Rights, and the Public's Health

Abstract

Do terminally ill patients who have exhausted all other available, government-approved treatment options have a constitutional right to experimental treatment that may prolong their lives? On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held "Yes." The plaintiffs, Abigail Alliance for Better Access to Developmental Drugs and Washington Legal Foundation, sought to enjoin the Food and Drug Administration ("FDA") from refusing to allow the sale of investigational new drugs that had not yet been FDA-approval for marketing.

The Abigail Alliance decision generated considerable interest from various constituencies. On one side, libertarian, free market scholars support the panel's decision as a strong recognition of individual rights. On the other side, public health and consumer safety advocates are concerned that the decision may do more harm than good and urge the en banc court to adopt a more paternalistic or pro-regulatory stance with respect to the FDA's legitimate authority over new drug development. Meanwhile, in step with the panel decision, FDA proposed amendments to regulations on pre-market access to experimental drugs, beyond the existing "compassionate use" case-by-case exceptions. In addition, both sides of the aisle in Congress have urged regulators and pharmaceutical companies to allow more liberal access, in some case, more liberal than either the D.C. Circuit opinion or agency guidelines would allow.

Perhaps motivated by overwhelming compassion for terminally ill patients, proponents of expanding access to experimental drugs fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of current, future, and potential patients who might benefit from the deliberate, careful process of new drug approval, as it currently operates under FDA's auspices.