A US Court of Appeals has ruled that terminally-ill patients have no constitutional right of access to potentially life-saving drugs which are not yet approved by the Food and Drug Administration, even though a treatment’s safety has been established and doctors believe it offers the best chance of improving their patients’ health.
The 8-2 ruling by the Court of Appeals for the District of Columbia Circuit reverses an appeal court decision this year, in a long-running case first brought against the FDA by patient advocacy group The Abigail Alliance for Better Access to Experimental Drugs and the free-market Washington Legal Foundation (WLF) back in 2003.
In the new ruling, Judge Thomas Griffith rejected the plaintiffs’ claim that terminally-ill patients have the fundamental right to access experimental drugs. “There is no such right,” he said, adding: “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.”
While terminally-ill patients “desperately need curative treatments…their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit,” he added. Moreover, commenting on the WLF’s claim that a terminally-ill patient’s constitutional right to take experimental drugs is a right to engage in self-defence, in which the FDA should not interfere, Judge Griffith said that the right of self-defence “cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgement expressed through the clinical testing process.”
However, in a strongly dissenting opinion, two judges stated that denying a terminally-ill patient the only chance to survive, “without even a strict showing of government necessity” for such a decision, “presupposes a dangerous brand of paternalism.” In the minority opinion, Judge Judith Rogers wrote that, while the courts have established the right “to marry, to fornicate, to have children, to control the education and upbringing of children, to perform varied sexual acts in private and to control one’s own body even if it results in one’s own death or the death of a foetus, the right to try to save one’s life is left out in the cold, despite its textual anchor in the right to life.”
The judgement suggested that the plaintiffs should pursue their demands through Congress rather than the courts, but the WLF and Frank Burroughs - who founded the Alliance in 2001 after his daughter Abigail died because she was denied access to drugs that her oncologist believed could save or prolong her life – have said they will now seek a review of the decision in the Supreme Court.
“We’re obviously disappointed by the court’s ruling, but we believe that the strong dissent by Judge Judith Rogers, joined by Chief Judge Douglas Ginsburg, will carry the day when we take the case to the Supreme Court,” said Paul Kamenar, the WLF’s senior executive counsel. If the decision is not overturned, an FDA bureaucrat can continue to slam the door in the face of a dying cancer patient, said the WLF, in a statement.
FDA officials welcomed the court ruling and pointed out that some patients and doctors do now have limited access to therapies which are still in development. They added that agency is currently reviewing comments on its proposal, issued last December, to make expanded access to experimental drugs available to individual patients and larger groups, for a fee, “when there is no satisfactory alternative therapy to diagnose, monitor or treat the disease or condition.”
The proposal aims to encourage companies to make such drugs available and to reduce barriers for healthcare practitioners in obtaining them, said FDA deputy commissioner for operations, Janet Woodcock. By Lynne Taylor