"FDA's handing of Genasense lays bare the all too common, aggressive incompetence of the FDA's cancer-drug division and should lead to an immediate examination of its policies and leadership, followed by swift corrective action," Steven Walker, co-founder and chief adviser for the Abigail Alliance for Better Access to Developmental Drugs, writes in a Wall Street Journal opinion piece. Walker details FDA's handling of the melanoma and chronic lymphocytic leukemia drug Genasense, manufactured by Genta. Walker writes, "Despite compelling evidence that Genasense is making progress in fighting both" melanoma and CLL, FDA "appears determined to kill the drug."

The Abigail Alliance filed a lawsuit against the agency to challenge its "refusal to grant access to investigational drugs, even as a last resort for terminally ill patients," Walker writes. FDA last year lost the case in front of a three-judge panel, which found that the agency "is violating the due-process rights of terminally ill patients" through its experimental drug access policy, according to Walker. The agency has requested a rehearing by the full Washington, D.C., Court of Appeals. Walker writes that "we can only hope the appeals court disagrees" that FDA has "unlimited" power "to control us and even deny us the pursuit of life itself." He concludes, "An agency that blocks progress against deadly diseases -- while arguing that its power to do so is above challenge -- is in dire need of a court supervised review" (Walker, Wall Street Journal, 5/4).

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