Access before Approval — A Right to Take Experimental Drugs?

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Abstract
A surprising court decision this past May has advanced an effort to allow terminally ill people to purchase experimental drugs after initial safety testing but before they have been shown to work. A three-judge panel of the U.S. Court of Appeals for the D.C. Circuit was considering a lawsuit by the Abigail Alliance, a patient-advocacy group, against the Food and Drug Administration (FDA). Two members of the panel ruled that patients with life-threatening and otherwise untreatable diseases have a constitutional right to seek experimental treatments for which efficacy is not yet established and that the government cannot interfere unless it proves it has a “compelling interest.” The suit was sent back to a lower court, which had dismissed it. The dissenting judge, Thomas Griffith, wrote that “there is no evidence in this Nation's history and traditions of a right to access experimental drugs.”