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NEWS |
Patient Group Seeks Overhaul of FDA Clinical Trial System in Court
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Forces are allied for what could become an epic battle over the U.S. Food and Drug Administration's (FDA) authority to regulate the safety and efficacy of new drugs. In a two-pronged test of the FDA's current new drug standards, would-be reformers are challenging the constitutionality of the FDA's drug approval standards and seeking legislative action that would overhaul the current system of clinical trials.
The movement has both researchers and patient advocates worried about hurting vulnerable, desperate patients with drugs that haven't proven effective and may, in fact, cause harm. Its debate hinges on the point at which terminally ill patients should have access to experimental drugs.
In 2003, the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the FDA on the grounds that patients have a constitutional right to assume the risk of taking an unproven experimental drug. On May 2, the U.S.
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