American Journal of Law & Medicine

Right to Access Experimental Drugs: Terminally Ill Patients Have the Right to Access Experimental Drugs Pending Final FDA Approval--Abigail Alliance v. Von Eschenbach (1).(Select Recent Court Decisions)

Right to Access Experimental Drugs: Terminally Ill Patients Have the Right to Access Experimental Drugs Pending Final FDA Approval--Abigail Alliance v. Von Eschenbach, 445 F.3d 470 (D.C. Cir. 2006).

The United States Court of Appeals for the District of Columbia Circuit recently held that terminally ill patients have a due process right to access potentially life-sustaining drugs that the Food and Drug Administration ("FDA") has approved as safe for expansive testing on human subjects, but has not yet approved to be commercially marketed. (2)

The FDA has the exclusive authority, under the Food, Drug, and Cosmetic Act ("FDCA"), (3) to approve new drugs before they are brought into the interstate market. (4) The FDCA instructs the FDA to create standardized rules for approving these new drugs. (5) Under this authority, the FDA has promulgated a three-phase requirement for the testing of new drugs. (6) Phase I involves the testing of the experimental drug on twenty to eighty human subjects to determine potential side effects and safety for further human testing. (7) Phase II focuses more on the effectiveness of the drug while also evaluating further safety risks by testing the drug on several hundred human subjects. (8) Finally, Phase III involves the testing of the drug in expanded trials on thousands of human subjects. (9)

The Abigail Alliance for Better Access to Developing Drugs ("Alliance") submitted a proposal to the FDA encouraging new regulations to give terminally ill patients access to investigational drugs that have only passed Phase I testing. …

Log in to your account to read this article – and millions more.