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Congress may limit or even eliminate a necessity defense that might otherwise be available. That is precisely what the Food, Drug, and Cosmetic Act has done. Congress has prohibited general access to experimental drugs, 21 U.S.C.S. § 355(a), and has prescribed in detail how experimental drugs may be studied and used by the scientific and medical communities, 21 U.S.C.S. § 355(i). The United States Supreme Court has concluded that the common law defense of necessity remains controversial and cannot override a value judgment already determined by the legislature.
The Abigail Alliance for Better Access to Developmental Drugs (the "Alliance") was an organization of terminally ill patients and their supporters seeking expanded access to experimental drugs for the terminally ill. The Food, Drug, and Cosmetic Act ("FDCA" or "Act"), however, would generally prohibit access to new drugs unless and until they have been approved by the Food and Drug Administration. Concluding that the FDA's current process for early access to new drugs was inadequate to meet the needs of its terminally ill members, the Alliance submitted its own proposals to the FDA. Those proposals culminated in a "citizen petition" to the FDA arguing that there was a different risk-benefit tradeoff facing patients who are terminally ill and who have no other treatment options. The FDA denied the petition. Consequently, the Alliance instituted an action before the court, arguing that the United States Constitution provided a right of access to experimental drugs for its members. The district court held that there was no such right. A divided appellate panel had reversed the district court, holding that a constitutional right of informed access to unapproved drugs existed and concluding that where there were no alternative government-approved treatment options, a terminally ill, mentally competent adult patient's informed access to potentially life-saving investigational new drugs determined by the FDA after Phase I trials to be sufficiently safe for expanded human trials warranted protection under the Due Process Clause.
Did the Constitution provide terminally ill patients a right of access to experimental drugs that have passed limited safety trials but have not been proven safe and effective?
On en banc review, the appellate court affirmed the district court's decision, holding that the nation's history and tradition did not establish a fundamental substantive due process right of access to experimental drugs for the terminally ill. Further, neither the common law doctrine of necessity, the tort of intentional interference with rescue, nor the right to self-defense established a self-preservation right giving the terminally ill access to experimental drugs. Finally, the FDA's policy of limiting access to investigational drugs was rationally related to the legitimate state interest of protecting patients from potentially unsafe drugs with unknown therapeutic effects.