[JURIST] The US Court of Appeals for the District of Columbia Circuit ruled [opinion, PDF] Tuesday that terminally ill patients do not have a constitutional right to use experimental drugs that have passed limited safety trials but have not been proven safe and effective under requirements from the Food and Drug Administration [official website]. According to the appeals court, the plaintiffs - the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation (WLF) [advocacy websites] - argued in their lawsuit [case materials] that the FDA's "lengthy clinical trials, combined with the 'FDA's restrictions on pre-approval availability, amount to a death sentence for ... [terminally ill] patients.'" The plaintiffs also argued that "the FDA's exceptions to the clinical testing process" do not "provide the terminally ill the access they need." The court upheld a lower court ruling rejecting the plaintiffs arguments and wrote:
Although 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. Thus, we must conclude that, prior to the distribution of a drug outside controlled studies, the Government has a rational basis for ensuring that there is a scientifically and medically acceptable level of knowledge about the risks and benefits of such a drug. We therefore hold that 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 court urged the Abagail Alliance, an nonprofit organization that seeks to expand access to experimental drugs for the terminally ill, to advance its "arguments about morality, quality of life, and acceptable levels of medical risk" in the legislature, saying that the courts should not be injected "into unknown questions of science and medicine."
The WLF has indicated it plans to appeal the decision to the US Supreme Court. The New York Times has more.