According to a federal appeals court ruling, patients with terminal illnesses do not have a constitutional right to use medicines that have not yet won regulatory approval.
The 8-to-2 decision by the Court of Appeals for the District of Columbia Circuit came after a closely watched and emotional case that saw desperate patients willing to try unproven, even risky, therapies come against those arguing that drugs should be proved safe and effective before they are made available.
The decision preserves the current regulatory system. If it had gone the other way “it would have undermined the entire drug approval process,” opines William B. Schultz, a former deputy commissioner of the Food and Drug Administration.
The case was filed against the Food and Drug Administration in 2003 by the Abigail Alliance for Better Access to Developmental Drugs, a group founded by a man whose daughter Abigail died from cancer after a long battle to receive treatment with experimental drugs that were eventually approved.
The group, joined by the Washington Legal Foundation, argued that forcing patients to wait years for a drug to go through the process of clinical trials deprived dying patients of their right to self-defense and violated the Fifth Amendment clause stating that people cannot be deprived of life, liberty or property without due process of law.
A district court ruled against the Abigail Alliance. Though an appeals court panel reversed the decision, the full appeals court yesterday upheld the original district court decision.