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Does the Constitution Provide a Right of Access to Experimental Drugs?

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Abstract:

The Abigail Alliance case directly poses the question of whether terminally ill patients have a constitutional right of access to unapproved drugs. The case arose following the death of a young woman from cancer. She had failed standard therapies and had unsuccessfully sought access to an unapproved drug in a clinical trial as a last resort. Following her death, her supporters brought a lawsuit asserting a constitutional right of access to such a product. If such a constitutional right exists, it has serious implications for patients, health care providers, the FDA, insurers, and manufacturers. This article reviews the legal basis for the asserted constitutional right, current case law, and the implications for health care providers.

Keywords: ABIGAIL ALLIANCE; ACCESS TO EXPERIMENTAL DRUGS; CLINICAL TRIALS; FDA AND SUBSTANTIVE DUE PROCESS; OFF-LABEL USE; RIGHT TO ACCESS UNAPPROVED DRUGS

Document Type: Research Article

Publication date: December 1, 2007

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