Patient group seeks overhaul of FDA clinical trial system in court.

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 effi cacy 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. Circuit Court of Appeals for the District of Columbia reversed a lower court dismissal of the suit, reviving the group's argument. " There's no stopping [the lawsuit] now, I mean as far as the legal path, all the way to the Supreme Court if necessary , " said Frank Burroughs, president of the Abigail Alliance, an organization dedicated to getting drugs to patients much sooner than current standards allow. In a parallel tactic, the group worked with Sen. Sam Brownback (R-Kan.) to introduce legislation that would create a new three-tiered approval system for drugs. The bill, S.1956, questions the necessity of placebo-controlled clinical studies and gives greater weight to " clinical judgment " than statistical analysis in evaluation of the safety and effi cacy of drugs, biological products, and devices. The bill also states that seriously ill patients should have access to investiga-tional drugs approved under " Tier I, " in which drugs would be available based " primarily upon clinical evaluation, not statistical analysis. " The bill has been referred to a Senate committee for review. The lawsuit and bill are part of a larger push for expedited review of drugs that would reduce the reliance upon large, blinded, placebo-controlled clinical trials, long the mainstay of the FDA's regulatory system. Under the current clinical trial structure , phase I testing is designed to determine only how much of a drug can be given safely, not whether it effectively treats a disease. Because of the inherent risk to patients …