In an 8-2 en banc ruling, the D.C. Court of Appeals has held that terminally ill patients do not have a constitutional due process right to access experimental drugs. Specifically, in Abigail Alliance v. von Eschenbach, No. 04-5350, 2007 WL 2238914 (D.C. Cir. Aug. 7, 2007), the court permitted the FDA to restrict access to drugs that have passed only “Phase I” of the FDA’s experimental drug approval process – that is, drugs deemed safe for limited human testing, but not yet approved for more widespread testing or commercial use. In the words of Judge Thomas B. Griffith, writing for the majority, “the FDA’s policy of limiting access to investigational drugs is rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects.”
The en banc ruling reverses a May 2006 three-judge panel decision in this case, which recognized a due process right for terminal patients to assume the risks of receiving experimental drug treatment without FDA interference. Judge Judith W. Rogers, author of the reversed panel decision, dissented from the majority en banc opinion, arguing that it “reflects a flawed conception of the right” sought by those seeking treatment. Instead of a narrow right to access experimental drugs deemed inappropriate for patient use, Judge Rogers argued that the real issue involved “the right to preserve life, a corollary to the right to life enshrined in the Constitution.” Accordingly, Judge Rogers concluded that a strict scrutiny analysis was required.
The Abigail Alliance, an advocacy group for the terminally ill, is expected to seek Supreme Court review. A copy of the D.C. Court of Appeal’s en banc decision is attached here.