WLF Asks Supreme Court to Hear Abigail Alliance Case on Access to Experimental Drugs

October 1, 2007

On September 28, 2007, the Washington Legal Foundation (“WLF”) asked the Supreme Court to review the U.S. Court of Appeals for the District of Columbia Circuit’s recent ruling in Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach concerning access to experimental therapies.  As we previously reported, the full D.C. Court of Appeals ruled on August 7, 2007 that “there is no fundamental right ‘deeply rooted in this Nation’s history and tradition’ of access to experimental drugs for the terminally ill.”  The decision reversed a May 2006 D.C. Court of Appeals panel decision.

WLF’s petition to the Supreme Court caps off an effort that began in 2003 when the organization filed suit on behalf of itself and the Abigail Alliance for Better Access to Developmental Drugs to establish a right for terminally ill patients to gain access to investigational drugs.  The organization is asking the Supreme Court to reinstate the May 2006 D.C. Court of Appeals panel decision that where there are no other FDA-approved treatment options, a terminally ill patient’s access to investigational new drugs is a “fundamental right” protected under the Due Process Clause of the U.S. Constitution.

WLF requests the Supreme Court’s consideration of the following question:

Whether the Due Process Clause protects the right of a terminally ill patient with no remaining approved treatment options to attempt to save her own life by deciding, in consultation with her own doctor, whether to seek access to investigational medications that the Food and Drug Administration concedes are safe and promising enough for substantial human testing.

The organization contends in its petition that:

The D.C. Circuit [] held that FDA regulations interfering with the medical judgment of terminally ill patients and their doctors do not implicate fundamental rights, and should be subjected to nothing but rational basis review.  That is a profound and important error.  This Court has rightly urged caution in substantive due process cases, but as the dissent below noted “[t]o deny the constitutional importance of the right to life and to attempt to preserve life is to move from judicial modesty to judicial abdication.”  The D.C. Circuit’s decision abandons the textual commitment to “life” in the Due Process Clause, creates bizarre inconsistencies with this Court’s cases, and denies thousands of Americans their most important rights. [(citation omitted)]

The Supreme Court will likely decide whether or not to hear the case by January 2008.

Categories: Drug Development