Backing the terminally ill	November 2008

Patients rights groups continue to lobby on behalf of terminally ill patients for legal rights to expanded access programs.

The U.S. Supreme Court issued an order in January, declining to take up the issue of whether terminally ill patients have a fundamental right – protected by the U.S. Constitution – to access experimental drugs that have not yet been fully approved by FDA. The denial was a setback for the Washington Legal Foundation, which filed the review petition on behalf of itself and the Abigail Alliance for Better Access to Developmental Drugs, a patients rights group. Expanded access programs, also referred to as compassionate use programs, early access programs, and named patient programs, treat patients who cannot enroll in controlled trials or wait until a drug is commercially available.

In 2003, the Abigail Alliance for Better Access to Developmental Drugs sued FDA to gain greater access to unapproved drugs. The Alliance was founded by Frank Burroughs, the father of Abigail Burroughs, a woman who was diagnosed with squamous cell carcinoma of the head and neck. After conventional therapies failed, she campaigned hard for access to experimental drugs. She did not meet entry criteria for clinical trials of two unapproved cancer drugs – Eribitux from ImClone Systems Inc. (imclone.com) and Iressa from AstraZeneca (astrazeneca.com). Ms. Burroughs died while waiting for newer treatment. Erbitux was later approved for head and neck cancer and Iressa for lung cancer.

In August 2007, the U.S. Court of Appeals for the District of Columbia Circuit ruled in an 8-2 decision that terminally ill patients do not have a constitutional right to have access to life-saving drugs that are being tested by FDA in clinical trials where it already has been established that the experimental drugs are safe to use. The ruling by the full court, written by Judge Thomas Griffith, reversed an earlier 2-1 decision in favor of the Washington Legal Foundation and the Abigail Alliance, that there is a right of access to such life-saving drugs.

The Washington Legal Foundation had urged the court to hold that once FDA has determined, after Phase I trials, that a potentially life-saving investigational new drug is sufficiently safe for expanded human trials, terminally ill patients have a constitutional right to seek treatment with the drug if there are no other FDA-approved drugs available to the patient.

The Washington Legal Foundation argued that the Fifth Amendment’s Due Process Clause encompasses a right, recognized throughout American history, of all individuals facing terminal illnesses to make fundamental decisions regarding whether to seek or not to seek medical treatment. The Washington Legal Foundation argued that if FDA wishes to prevent such patients from gaining access to investigational drugs that have completed Phase I trials, it bears the burden of demonstrating that its restrictions are narrowly tailored to serve governmental interest.