South-Western Legal Studies in Business

Preventing Terminally Ill Patients Access to Developmental Drugs Violates Due Process
Description

Appeals court held that for the FDA to prevent voluntary access by terminally ill patients to drugs approved for human trials is a violation of the Fifth Amendment right of due process that guarantees protection of life.

Topic

Consumer Protection

Key Words

FDA; Drug Approval; Informed Access; Terminal Illness; Due Process

C A S E   S U M M A R Y
Facts

The Abigail Alliance for Better Access to Developmental Drugs (Alliance) sued to enjoin the FDA from continuing to enforce a policy barring the sale of new drugs that the FDA has approved for trials on humans but not for wider use. The Alliance specifically sought access for potentially life-saving drugs under investigation for use by terminally-ill adults who wish access to such drugs. The Alliance claimed that denial of access to the drugs was a violation of due process rights to privacy, liberty, and life for terminally ill patients. The district court dismissed the suit. The Alliance appealed.

Decision

Reversed and remanded. New drugs that complete Phase I of the FDA process are deemed sufficiently safe to enter Phase II testing on human subjects in trials. This process takes an average of seven years before general use is approved by the FDA. The Due Process Clause of the Fifth Amendment holds that "no person shall be deprived of life, liberty, or property, without due process of law." The Supreme Court has held that this means more than "fair process." It means substantive protection to those rights, especially in matters of "personal dignity." Terminally ill, mentally competent adult patients have a due process right to informed access to potentially life-saving investigational new drugs that have been determined to be sufficiently safe for expanded human trials (Phase II), where there are no alternative government-approved treatment options.

Citation

Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, 445 F.3d 470 (D.C. Cir., 2006)

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